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Lufenuron

Detailed information about Lufenuron

Official label facts Owner quick guide first Marketing clearly labeled
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Pet Owner Quick Guide

Start here: what this medicine is for, what it does, and when it's usually needed.

Usually used for:

For use in dogs and puppies for the prevention of heartworm disease caused by Dirofilaria immitis , for prevention and control of flea populations, control of adult Ancylostoma caninum (hookworm), and removal and control...

What it does:

For control of flea populations. For use in cats and kittens, 4 weeks of age and older, for the control of flea populations. Lufenuron controls flea populations by preventing the development of flea eggs and does not kil...

When it's needed:

For oral use in cats 6 weeks of age or older, once a month, mixed with food. Administer in conjunction with a full meal to ensure adequate absorption. Treat all cats in the household to ensure maximum benefits. Because t...

Call your vet sooner if you notice:

  • For oral use in cats 6 weeks of age or older, once a month, mixed with food. Administer in conjunction with a full meal to ensure adequate absorption. Treat all cats in the household to ensure maximum benefits. Because the drug has no affect on adult fleas, the concurrent use of insecticides that kill adults may be necessary depending on the severity of the infestation. Administer tablet(s) after or in conjunction with a full meal to ensure adequate absorption. Administer tablet(s) once a month. All cats in a household should be treated to achieve maximum efficacy. Administer tablet(s) after or in conjunction with a full meal to ensure adequate absorption. Administer tablet(s) once a month.. All dogs in a household should be treated to achieve maximum efficacy.

Commonly reported reactions:

  • (1 reports)
  • (1 reports)
  • (1 reports)

What to ask your vet today:

  • Is this medicine the right fit for my pet’s current symptoms?
  • Which warning signs mean I should call back right away?
  • How should I handle missed doses or refusal to take the medicine?
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Lufenuron

Lufenuron

Drug type: Generic ingredient • Branded profile • FDA branded products available

Species: Both

Manufacturer: Elanco US Inc.

Quick Facts

Official label facts first, then secondary summaries. Marketing content is separated below.

Species: Both
Manufacturer: Elanco US Inc.
Form: Chewable Tablets, Liquid (Suspension), Tablet, Tablet (Chewable)
Identifiers:
NADA: 141026 NADA: 141035 NADA: 141062 NADA: 141084 NADA: 141105 NADA: 141204 NADA: 141205 NADA: 141333 NDC Package: 0061-5350-01 NDC Package: 0061-5350-02 NDC Package: 0061-5351-01 NDC Package: 0061-5351-02 NDC Package: 0061-5352-01 NDC Package: 0061-5352-02 NDC Package: 0061-5353-01 NDC Package: 0061-5353-02 NDC Package: 0061-5354-01 NDC Package: 0061-5354-02 NDC Package: 0061-5355-01 NDC Package: 0061-5355-02
Source metadata:

Warnings / Contraindications

For oral use in cats 6 weeks of age or older, once a month, mixed with food. Administer in conjunction with a full meal to ensure adequate absorption. Treat all cats in the household to ensure maximum benefits. Because the drug has no affect on adult fleas, the concurrent use of insecticides that kill adults may be necessary depending on the severity of the infestation. Administer tablet(s) after or in conjunction with a full meal to ensure adequate absorption. Administer tablet(s) once a month. All cats in a household should be treated to achieve maximum efficacy. Administer tablet(s) after or in conjunction with a full meal to ensure adequate absorption. Administer tablet(s) once a month.. All dogs in a household should be treated to achieve maximum efficacy.

  • High: For oral use in cats 6 weeks of age or older, once a month, mixed with food. Administer in conjunction with a full meal to ensure adequate absorption. Treat all cats in the household to ensure maximum benefits. Because the drug has no affect on adult fleas, the concurrent use of insecticides that kill adults may be necessary depending on the severity of the infestation. Administer tablet(s) after or in conjunction with a full meal to ensure adequate absorption. Administer tablet(s) once a month. All cats in a household should be treated to achieve maximum efficacy. Administer tablet(s) after or in conjunction with a full meal to ensure adequate absorption. Administer tablet(s) once a month.. All dogs in a household should be treated to achieve maximum efficacy.
Source metadata:

Adverse Reactions

Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.

Tap or hover a reaction to see what it means in plain language.

Tracked signals
32
Reported cases
32
Serious reports
26
Species represented
2
Most Reported Reactions
Reaction Cases Species Serious cases
1 Dog 1
1 Dog 1
1 Dog 1
1 Dog 1
1 Dog 1
1 Dog 1
1 Dog 1
1 Dog 1

Species coverage: Dog (25) Cat (7)

View detailed reaction table
Reaction Species Seriousness Frequency Reports
Dog Serious - 1
Dog Serious - 1
Dog Serious - 1
Cat Serious - 1
Dog Serious - 1
Dog Serious - 1
Dog Serious - 1
Dog Serious - 1
Dog Serious - 1
Dog Serious - 1
Dog Serious - 1
Dog Serious - 1
Dog Serious - 1
Dog Serious - 1
Cat Non-serious - 1
Cat Non-serious - 1
Cat Non-serious - 1
Cat Non-serious - 1
Dog Serious - 1
Cat Non-serious - 1
Dog Serious - 1
Dog Serious - 1
Dog Serious - 1
Dog Serious - 1
Dog Serious - 1
Dog Serious - 1
Cat Non-serious - 1
Dog Serious - 1
Dog Serious - 1
Dog Serious - 1
Dog Serious - 1
Dog Serious - 1
Source metadata:

Storage & Handling

No storage/handling guidance is linked yet.

Source metadata: No source yet.

Documents

Official label facts are separated from secondary summaries.

Official documents: 24 • Secondary summaries: 0

Official label facts
Secondary summaries

No source yet.

Source metadata:

Promotional Materials (Marketing)

This content is marketing material and not clinical guidance.

No marketing assets are linked yet.

No source yet.

Source metadata: No source yet.
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Technical appendix (vet reference)

Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.

At a Glance

Quick facts and links to official labeling and safety signals.

Data freshness
  • Medication catalog: Source PetWisePlus | Refreshed Feb 12, 2026, 10:44 PM UTC
  • Animal Drugs @ FDA: Source FDA | Refreshed Feb 16, 2026, 11:00 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Feb 16, 2026, 11:00 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Feb 16, 2026, 11:02 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:20 AM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: Program® Cat Flavor Tabs™ Program® Flavor Tabs® Program® Flavor Tabs® and Capstar® Flea Management System™ Program™ 6 Month Injectable for Cats Program™ Suspension Sentinel® Flavor Tabs® Sentinel® Flavor Tabs® and Capstar® Flea Management System™ Sentinel® Spectrum®
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: Cat And Kitten, Cats and kittens, Dog, Dogs and puppies
Rx/OTC: OTC, RX
Form/route: Chewable Tablets, Liquid (Suspension), Tablet, Tablet (Chewable) • Oral, Subcutaneous
Applications: NADA 141-084 • NADA 141-204 • NADA 141-333 • NADA 141-035 • NADA 141-026 • NADA 141-105 • NADA 141-062 • NADA 141-205
Documents: 16 (FOI: 16) • SPL: 8 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 56 • Cat 8 • View
Case summaries: 10 (showing 8) • View
openFDA reports are unverified and do not prove causation.
Explore
Linked using: Fda_Label (0.95), Fda_Label (0.95)
Diagnosis Codes
ICD10_CM: B74.8 ICD10_CM: B88.1
Other filariases

Counseling and Monitoring Highlights

Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.

Owner-facing counseling points
  • For oral use in cats 6 weeks of age or older, once a month, mixed with food. Administer in conjunction with a full meal to ensure adequate absorption. Treat all cats in the household to ensure maximum benefits. Because the drug has no affect on adult fleas, the concurrent use of insecticides that kill adults may be necessary depending on the severity of the infestation. Administer tablet(s) after or in conjunction with a full meal to ensure adequate absorption. Administer tablet(s) once a month. All cats in a household should be treated to achieve maximum efficacy. Administer tablet(s) after or in conjunction with a full meal to ensure adequate absorption. Administer tablet(s) once a month.. All dogs in a household should be treated to achieve maximum efficacy. (Contraindication, High)
Top reaction signals
Anaphylaxis (1) Appetite loss (1) Behavioural disorder NOS (1) Death (1) Decreased bowel movements (1) Diarrhoea (1) Digestive tract disorder NOS (1) Elevated creatinine (1) Facial swelling (see also Skin) (1) Haematuria (1) Haemorrhagic diarrhoea (1) High pancreatic-specific lipase (1) Hives (see also Skin) (1) Hyperphosphataemia (1) Injection site abscess (1) Injection site mucopurulent discharge (1)

Identifiers & Packages

Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.

Identifiers
NADA: 141026 NADA: 141035 NADA: 141062 NADA: 141084 NADA: 141105 NADA: 141204 NADA: 141205 NADA: 141333 NDC Package: 0061-5350-01 NDC Package: 0061-5350-02 NDC Package: 0061-5351-01 NDC Package: 0061-5351-02 NDC Package: 0061-5352-01 NDC Package: 0061-5352-02 NDC Package: 0061-5353-01 NDC Package: 0061-5353-02 NDC Package: 0061-5354-01 NDC Package: 0061-5354-02 NDC Package: 0061-5355-01 NDC Package: 0061-5355-02 NDC Package: 0061-5356-01 NDC Package: 0061-5356-02 NDC Package: 0061-5357-01 NDC Package: 0061-5357-02
Package NDC Product NDC Form / Route Status
0061-5350-01 0061 -
0061-5350-02 0061 -
0061-5351-01 0061 -
0061-5351-02 0061 -
0061-5352-01 0061 -
0061-5352-02 0061 -
0061-5353-01 0061 -
0061-5353-02 0061 -
0061-5354-01 0061 -
0061-5354-02 0061 -
0061-5355-01 0061 -
0061-5355-02 0061 -
0061-5356-01 0061 -
0061-5356-02 0061 -
0061-5357-01 0061 -
0061-5357-02 0061 -
62157-587-01 62157 -
62157-588-01 62157 -
72969-114-10 72969 -
73377-136-01 73377 -

Enriched Documents

Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.

  • UCM292003.pdf • FOI summary • Official • Aug. 3, 2020
    FDA FOI summary for application 141333
  • FOI Summary sN-141-333 Approved September 28, 2017.pdf • FOI summary • Official • Aug. 3, 2020
    FDA FOI summary for application 141333
  • ucm117654.pdf • FOI summary • Official • Aug. 3, 2020
    FDA FOI summary for application 141204
  • N141084_Orig_4_10_1997.pdf • FOI summary • Official • Aug. 3, 2020
    FDA FOI summary for application 141084
  • N141084_Supp_6_17_1998.pdf • FOI summary • Official • Aug. 3, 2020
    FDA FOI summary for application 141084
  • ucm117024.pdf • FOI summary • Official • Aug. 3, 2020
    FDA FOI summary for application 141084
  • UCM487821.pdf • FOI summary • Official • Nov. 26, 2018
    FDA FOI summary for application 141035
  • N141035_Supp_12_31_1996.pdf • FOI summary • Official • Nov. 26, 2018
    FDA FOI summary for application 141035
  • UCM472708.pdf • FOI summary • Official • Nov. 26, 2018
    FDA FOI summary for application 141035
  • N141035_Supp_8_1_1998.pdf • FOI summary • Official • Nov. 26, 2018
    FDA FOI summary for application 141035
  • N141035_Supp_6_11_2003.pdf • FOI summary • Official • Nov. 26, 2018
    FDA FOI summary for application 141035
  • UCM487816.pdf • FOI summary • Official • Dec. 7, 2017
    FDA FOI summary for application 141026
  • N141026 Supp_12_31_1996.pdf • FOI summary • Official • Dec. 7, 2017
    FDA FOI summary for application 141026
  • N141105 Orig_3_31_1998.pdf • FOI summary • Official • Aug. 24, 2017
    FDA FOI summary for application 141105
  • ucm117656.pdf • FOI summary • Official • June 1, 2016
    FDA FOI summary for application 141205
  • UCM455993.pdf • FOI summary • Official • June 1, 2016
    FDA FOI summary for application 141062

Data Sources & Revision History

Every non-trivial field is expected to include provenance and update timestamps.

Official 19 Clinical 0 Manufacturer 0 Marketing 0
Current Field Facts
  • contraindications: For oral use in cats 6 weeks of age or older, once a month, mixed with food. Administer in conjunction with a full meal to ensure adequate absorption. Treat al… (Official, 2026-02-12)
  • side_effects: Top reported reactions (openFDA): INEFFECTIVE, HOOKS, Vomiting, Lack of efficacy (endoparasite) - heartworm, Diarrhoea, Lack of efficacy (heartworm), Lack of e… (Official, 2026-02-12)
  • usage: For control of flea populations. For use in cats and kittens, 4 weeks of age and older, for the control of flea populations. Lufenuron controls flea population… (Official, 2026-02-12)
Recent Revisions
  • side_effects updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields

FDA Products & Applications (Animal Drugs @ FDA)

Official sponsor/proprietary-name/application-status records linked by active ingredient.

Product Sponsor Application Status Published
Sentinel® Flavor Tabs®
RX
Lufenuron Milbemycin Oxime
Tablet • Oral
Label highlights
Official documents
Intervet, Inc. NADA 141-084 Approved Aug 3, 2020
Sentinel® Flavor Tabs® and Capstar® Flea Management System™
RX
Lufenuron Milbemycin Oxime Nitenpyram
Tablet • Oral
Label highlights
Official documents
Intervet, Inc. NADA 141-204 Approved Aug 3, 2020
Sentinel® Spectrum®
RX
Lufenuron Milbemycin Oxime Praziquantel
Chewable Tablets • Oral
Label highlights
Official documents
Intervet, Inc. NADA 141-333 Approved Aug 3, 2020
Program® Flavor Tabs®
OTC
Lufenuron
Tablet • Oral
Label highlights
Official documents
Elanco US Inc. NADA 141-035 Approved Nov 26, 2018
Program™ Suspension
OTC
Lufenuron
Liquid (Suspension) • Oral
Label highlights
Official documents
Elanco US Inc. NADA 141-026 Approved Dec 7, 2017
Program™ 6 Month Injectable for Cats
RX
Lufenuron
Liquid (Suspension) • Subcutaneous
Label highlights
Official documents
Elanco US Inc. NADA 141-105 Approved Aug 24, 2017
Program® Cat Flavor Tabs™
OTC
Lufenuron
Tablet (Chewable) • Oral
Label highlights
Official documents
Elanco US Inc. NADA 141-062 Approved Jun 1, 2016
Program® Flavor Tabs® and Capstar® Flea Management System™
RX
Lufenuron Nitenpyram
Tablet • Oral
Label highlights
Official documents
Elanco US Inc. NADA 141-205 Approved Jun 1, 2016

Data source: FDA Animal Drugs @ FDA (public search export).

What It's For (FDA Label Highlights)

Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.

Species: Dog, Excluding Under 2 Pounds • Dogs and puppies, excluding puppies under 4 weeks age
Composition / specifications
Tablets containing: 2.3 milligrams milbemycin oxime/46 milligrams lufenuron, 5.75 milligrams/115 milligrams, 11.5 milligrams/230 milligrams, and 23 milligrams/460 milligrams.
Dogs and Puppies (4 Weeks and Older; 2 Lbs or Greater)
Indication
For use in dogs and puppies for the prevention of heartworm disease caused by Dirofilaria immitis, for prevention and control of flea populations, control of adult Ancylostoma caninum (hookworm), and removal and control of adult Toxocara canis, Toxascaris leonine (roundworm), and Trichuris vulpis (whipworm) infections. Lufenuron controls flea populations by preventing the development of flea eggs and does not kill adult fleas. Concurrent use of insecticides may be necessary for adequate control of adult fleas. The concurrent use of flavored milbemycin oxime and lufenuron tablets is indicated to kill adult fleas and prevent flea eggs from hatching.
Dosage
SENTINEL FLAVOR TABS are given orally, once a month, at the recommended minimum dosage of 0.23 mg/lb (0.5 mg/kg) milbemycin oxime and 4.55 mg/lb (10mg/kg) lufenuron.
Limitations
Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Administer tablets once a month, preferably on the same date each time. All dogs in a household should be treated to achieve maximum efficacy. Do not use in dogs less than 4 weeks of age and less than 2 pounds body weight To ensure adequate absorption, always administer sentinel® flavor tabs® to dogs immediately after or in conjunction with a normal meal..

FDA page: Open in Animal Drugs @ FDA

Species: Dogs and puppies, excluding puppies under 4 weeks age
Composition / specifications
Flavored tablets containing: 2.3 milligrams milbemycin oxime and 46 milligrams lufenuron, 5.75 milligrams milbemycin oxime and 115 milligrams lufenuron, 11.5 milligrams milbemycin oxime and 230 milligrams lufenuron, or 23 milligrams milbemycin oxime and 460 milligrams lufenuron.
concurrent with
Tablet contains 11.4 or 57 milligrams nitenpyram.
Dogs
Indication
The concurrent use of flavored milbemycin oxime and lufenuron tablets with nitenpyram tablets is indicated to kill adult fleas and prevent flea eggs from hatching.
Dosage
0.5 milligram milbemycin oxime and 10 milligrams lufenuron per kilogram of body weight, once a month. used concurrently with One 11.4-mg tablet for dogs weighing less than 25 lb or one 57 mg tablet for dogs weighing more than 25 lbs, once or twice weekly.
Limitations
The concurrent use of nitenpyram tablets and flavored milbemycin/lufenuron tablets shall be by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
Each chewable tablet contains: 2.3 mg milbemycin oxime/46 mg lufenuron/22.8 mg praziquantel; 5.75 mg milbemycin oxime/115 mg lufenuron/57 mg praziquantel; 11.5 mg milbemycin oxime/230 mg lufenuron/114 mg praziquantel; 23.0 mg milbemycin oxime/460 mg lufenuron/228 mg praziquantel
Dogs
Indication

For the prevention of heartworm disease caused by Dirofilaria immitis; for the prevention and control of flea populations (Ctenocephalides felis); and for the treatment and control of adult roundworm (Toxocara canis, Toxascaris leonina), adult hookworm (Ancylostoma caninum), adult whipworm (Trichuris vulpis), and adult tapeworm (Dipylidium caninum,Taenia pisiformis, Echinococcus multilocularis and Echinococcus granulosus) infections in dogs and puppies two pounds of body weight or greater and six weeks of age and older.

Dosage

SENTINEL SPECTRUM is given orally, once a month, at the minimum dosage of 0.23 mg/pound body weight (0.5 mg/kg) of milbemycin oxime, 4.55 mg/pound (10 mg/kg) of lufenuron, and 2.28 mg/pound (5 mg/kg) of praziquantel. For heartworm prevention, give once monthly beginning within 1 month of the dog’s first seasonal exposure to mosquitoes and continuing until at least 6 months after the dog’s last seasonal exposure.

Limitations

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Dog, Excluding Under 6 Weeks Age • Cats and kittens, excluding kittens under 6 weeks age
Composition / specifications
Each tablet contains either 45, 90, 204.9, or 409.8 milligrams of lufenuron.
Cats and Kittens (4 Weeks of Age and Older)
Indication
For use in cats and kittens, 4 weeks of age and older, for the control of flea populations. Lufenuron controls flea populations by preventing the development of flea eggs and does not kill adult fleas. Concurrent use of insecticides may be necessary for adequate control of adult fleas.
Dosage
Minimum of 30 milligrams of lufenuron per kilogram (13.6 milligrams per pound) of body weight.
Limitations
Administer tablet(s) after or in conjunction with a full meal to ensure adequate absorption. Administer tablet(s) once a month. All cats in a household should be treated to achieve maximum efficacy.
Dogs (4 Weeks of Age and Older)
Indication

For use in dogs and puppies, 4 weeks of age and older, for the prevention and control of flea populations. Lufenuron controls flea populations by preventing the development of flea eggs and does not kill adult fleas. Concurrent use of insecticides may be necessary for adequate control of adult fleas.

Dosage
Minimum of 10 milligrams of lufenuron per kilogram (4.5 milligrams per pound of body weight).
Limitations
Administer tablet(s) after or in conjunction with a full meal to ensure adequate absorption. Administer tablet(s) once a month.. All dogs in a household should be treated to achieve maximum efficacy.

FDA page: Open in Animal Drugs @ FDA

Species: Cats and kittens, excluding kittens under 6 weeks age
Composition / specifications
Each individual dose pack contains either 135 or 270 milligrams of lufenuron.
Cats and Kittens (6 Weeks of Age and Older)
Indication
For control of flea populations.
Dosage
Minimum of 13.6 milligrams per pound of body weight (30 milligrams per kilogram). Recommended dose of 135 milligrams for up to 10 pounds of body weight or 270 milligrams for 11 to 20 pounds. Cats over 20 pounds are provided the appropriate combination of packs.
Limitations
For oral use in cats 6 weeks of age or older, once a month, mixed with food. Administer in conjunction with a full meal to ensure adequate absorption. Treat all cats in the household to ensure maximum benefits. Because the drug has no affect on adult fleas, the concurrent use of insecticides that kill adults may be necessary depending on the severity of the infestation.

FDA page: Open in Animal Drugs @ FDA

Species: Cats and kittens, excluding kittens under 6 weeks age
Composition / specifications
Each milliliter of sterile aqueous suspension contains 10 milligrams of lufenuron.
Cats (6 Weeks of Age and Older)
Indication
For use in cats 6 weeks of age and older, for control of flea populations. Lufenuron controls flea populations by preventing the development of flea eggs and does not kill adult fleas. Concurrent use of insecticides may be necessary for adequate control of adult fleas.
Dosage
PROGRAM 6 Month Injectable for Cats is injected subcutaneously once every six months at the recommended minimum dosage of 4.54 mg lufenuron per pound (10 mg/kg) of body weight.
Limitations
Do not use in dogs. A severe local reaction may occur in dogs that is not seen in cats.

FDA page: Open in Animal Drugs @ FDA

Species: Cats and kittens, excluding kittens under 6 weeks age
Composition / specifications
Each flavor tablet contains 135 or 270 milligrams lufenuron.
Cats and Kittens (6 Weeks of Age and Older)
Indication
For control of flea populations.
Dosage
Minimum of 13.6 milligrams lufenuron per pound of body weight (30 milligrams per kilogram). Recommended 90 milligrams regular tablet for cats up to 6 pounds of body weight, 204.9 milligrams regular tablet for 7 to 15 pounds, 135 milligram flavor tablet for up to 10 pounds, 270 milligram flavor tablet for 11 to 20 pounds. Cats over 15 pounds (regular tablet) or over 20 pounds (flavor tablet) are provided the appropriate combination of tablets.
Limitations
For oral use in cats or kittens 6 weeks of age or older, once a month, directly or broken and mixed with wet food. Administer in conjunction with a full meal to ensure adequate absorption. Treat all cats in the household to ensure maximum benefits. Because the drug has no affect on adult fleas, the concurrent use of insecticides that kill adults may be necessary depending on the severity of the infestation.

FDA page: Open in Animal Drugs @ FDA

Species: Dogs and puppies, excluding puppies under 4 weeks age • Cat And Kitten, Excluding Under 4 Weeks Of Age
Composition / specifications
PROGRAM® Flavor Tabs : 45 mg, 90 mg, 204.9 mg and 409.8 mg lufenuron
CAPSTAR® Tablets: 11.4 mg and 57 mg nitenpyram
Cats
Indication
In cats and kittens, the concurrent use of PROGRAM® Flavor Tabs® and CAPSTAR® Tablets is indicated to kill adult fleas and prevent flea eggs from hatching. The effects of PROGRAM® Flavor Tabs®, which control flea populations, and CAP STAR® Tablets, which treat flea infestations, are combined to provide a FLEA MANAGEMENT SYSTEM™.
Dosage
Minimum of 30 mg lufenuron per kilogram (13.6 milligrams per pound ) of body weight, once a month. Concurrently with One 11.4-milligram tablet nitenpyram, once or twice weekly.
Limitations
For use in cats and kittens 4 weeks of age and older. The concurrent use of flavored milbemycin oxime and lufenuron tablets with nitenpyram tablets shall be by or on the order of a licensed veterinarian.
Dogs
Indication
In dogs and puppies, the concurrent use of PROGRAM® Flavor Tabs® and CAPSTAR® Tablets is indicated to kill adult fleas and prevent flea eggs from hatching. The effects of PROGRAM® Flavor Tabs®, which prevent and control flea populations, and CAPSTAR® Tablets, which treat flea infestations, are combined to provide a FLEA MANAGEMENT SYSTEM™.
Dosage
Minimum of 10 mg lufenuron per kilogram (4.5 milligrams per pound ) of body weight, once a month. Concurrently with One 11.4-milligram tablet for dogs weighing less than 25 lb or one 57 mg tablet for dogs weighing more than 25 lbs, once or twice weekly.
Limitations
For use in dogs and puppies 4 weeks of age and older. The concurrent use of flavored milbemycin oxime and lufenuron tablets with nitenpyram tablets shall be by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Official Documents (FDA)

Direct links to FDA-hosted PDFs and SPL packages (when available).

Documents
  • Summary

    Approval of this supplemental NADA will change the labeling for NADA 141-084.
    1. There are some minor revisions to clarify the currently approved text in the package insert.
    2. Use of the Client Information insert will be discontinued.
    3. The package insert is revised to include reference to the concurrent use of CAPSTAR® (nitenpyram) Tablets (NADA 141-175) to kill adult fleas. The information supporting approval for this concurrent use is documented in NADA 141-204.
    4. The unit dose cartons are revised to refer to concurrent use with CAPSTAR® Tablets.
    5. Each unit dose carton will contain an additional “FLEA MANAGEMENT SYSTEM™” package insert that provides specific information for using CAPSTAR® Tablets with SENTINEL® Flavor Tabs®.

  • Summary

    Supplement for the addition of a flavored tablet formulation with the same indications. The flavored tablets (in three tablet sizes) will replace the swallow tablets for dogs > 11 pounds. The swallow tablet will remain for dogs between 2-10 lbs.

  • Summary

    SENTINEL Tablets are indicated for use in dogs and puppies four weeks of age and older and two pounds body weight or greater, for the prevention of heartworm disease caused by Dirofilaria immitis, for the prevention and control of flea populations, the control of adult Ancylostoma caninum (hookworm), and the removal and control of adult Toxocara canis, Toxascaris leonina (roundworm) and Trichuris vulpis (whipworm) infections.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    For use in dogs 4 weeks and older to kill adult fleas and to prevent flea eggs from hatching.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    This supplement provides for the addition of the treatment and control of adult tapeworm (Dipylidium caninum) infections in dogs and puppies two pounds of body weight or greater and six weeks of age and older.

  • Summary
    For the prevention of heartworm disease caused by Dirofilaria immitis; for the prevention and control of flea populations (Ctenocephalides felis); and for the treatment and control of adult roundworm (Toxocara canis, Toxascaris leonina), adult hookworm (Ancylostoma caninum), adult whipworm (Trichuris vulpis), and adult tapeworm (Taenia pisiformis, Echinococcus multilocularis and Echinococcus granulosus) infections in dogs and puppies two pounds of body weight or greater and six weeks of age and older.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    PROGRAM Flavor Tabs are indicated for use in dogs and puppies six weeks of age and older for the prevention and control of flea populations and in cats and kittens, six weeks of age and older for the control of flea populations. Lufenuron controls flea populations by preventing the development of flea eggs and does not kill adult fleas. Concurrent use of insecticides may be necessary for adequate control of adult fleas.

  • Summary

    This supplemental provides for adding a flavored tablet formulation with the same indications as the non-flavored tablets.

  • Summary
    Approval of the supplemental NADA will change NADA 141-035 by adding the indication for the use of lufenuron tablets in cats and kittens, six weeks of age or older, at a minimum dose of 30 mg/kg for the control of flea populations. The cat [sic] will have labeling separate from the original dog approval.
  • Summary

    This supplemental provides for changing from Rx to OTC and addition of an Adverse Reactions section to the product labeling.

  • Summary
    PROGRAM Tablets are indicated for use in dogs, six weeks of age and older, for the prevention and control of flea populations.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    Change from Rx to OTC and addition of an Adverse Reactions section to the product label.

  • Summary
    Program® Suspension is indicated for use in cats, six weeks of age and older, for the control of flea populations.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    For use in cats, six weeks of age and older, for the control of flea populations. Lufenuron controls flea populations by preventing the development of flea eggs and does not kill adult fleas. Concurrent use of insecticides may be necessary for adequate control of adult fleas.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    Program Cat Flavor Tabs are indicated for use in cats and kittens, six weeks of age and older, for the control of flea populations.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    For use to kill adult fleas and to prevent flea eggs from hatching.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Usage

For control of flea populations. For use in cats and kittens, 4 weeks of age and older, for the control of flea populations. Lufenuron controls flea populations by preventing the development of flea eggs and does not kill adult fleas. Concurrent use of insecticides may be necessary for adequate control of adult fleas. For use in dogs and puppies, 4 weeks of age and older, for the prevention and control of flea populations. Lufenuron controls flea populations by preventing the development of flea eggs and does not kill adult fleas. Concurrent use of insecticides may be necessary for adequate control of adult fleas.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

For oral use in cats 6 weeks of age or older, once a month, mixed with food. Administer in conjunction with a full meal to ensure adequate absorption. Treat all cats in the household to ensure maximum benefits. Because the drug has no affect on adult fleas, the concurrent use of insecticides that kill adults may be necessary depending on the severity of the infestation. Administer tablet(s) after or in conjunction with a full meal to ensure adequate absorption. Administer tablet(s) once a month. All cats in a household should be treated to achieve maximum efficacy. Administer tablet(s) after or in conjunction with a full meal to ensure adequate absorption. Administer tablet(s) once a month.. All dogs in a household should be treated to achieve maximum efficacy.

Side Effects

No approved side-effect narrative is linked yet.

openFDA reaction signals are available for Dog 56 and Cat 8 (view top reported reactions).

Top Reported Reactions (openFDA)

Aggregated reaction terms from FDA openFDA reports (not verified; does not prove causation).

Dog
Digestive
Vomiting (870) Diarrhea (410) Appetite loss (1) Appetite loss (1) Appetite loss (1) Appetite loss (1) Appetite loss (1) Appetite loss (1)
Neurologic
Tiredness (lethargy) (320) Tiredness (lethargy) (1) Tiredness (lethargy) (1) Tiredness (lethargy) (1) Tiredness (lethargy) (1) Tiredness (lethargy) (1) Tiredness (lethargy) (1)
Effectiveness
Lack of efficacy (endoparasite) - heartworm (808) Lack of efficacy (400) Lack of efficacy (356)
Other
INEFFECTIVE, HOOKS (1387) INEFFECTIVE, HEARTWORM LARVAE (355) Elevated creatinine (1) Elevated creatinine (1) Elevated creatinine (1) Elevated creatinine (1) Elevated creatinine (1) Elevated creatinine (1) Haematuria (1) Haematuria (1) Haematuria (1) Haematuria (1) Haematuria (1) Haematuria (1) High pancreatic-specific lipase (1) High pancreatic-specific lipase (1) High pancreatic-specific lipase (1) High pancreatic-specific lipase (1) High pancreatic-specific lipase (1) High pancreatic-specific lipase (1) Hyperphosphataemia (1) Hyperphosphataemia (1) Hyperphosphataemia (1) Hyperphosphataemia (1) Hyperphosphataemia (1) Hyperphosphataemia (1) Proteinuria (1) Proteinuria (1) Proteinuria (1) Proteinuria (1) Proteinuria (1) Proteinuria (1) Pyuria (1) Pyuria (1) Pyuria (1) Pyuria (1) Pyuria (1) Pyuria (1)
Cat
Digestive
Vomiting (15)
Neurologic
Tiredness (lethargy) (15)
Effectiveness
Lack of efficacy (25) Lack of efficacy (ectoparasite) - flea (22)
Other
Injection site lump (25) Product Defect, General (16) Product problem (15) Other abnormal test result NOS (11)

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Adverse Event Case Summaries (openFDA)

These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.

Dog, Beagle, Female, 10.8 year • Drug: MSK, Unknown • Reactions: Vomiting, Appetite loss, Tiredness (lethargy), Urine abnormalities NOS, Elevated creatinine… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-051292
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 10.80 Year
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Vomiting Appetite loss Tiredness (lethargy) Urine abnormalities NOS Elevated creatinine Hyperphosphataemia Proteinuria High pancreatic-specific lipase Haematuria Pyuria
Outcomes: Ongoing

Dog, ['Retriever - Labrador', 'Dog (unknown)'], Male, 12.3 year, 23.678 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Lack of efficacy (endoparasite) - heartworm • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-030555
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Male
  • Age: 12.30 Year
  • Weight: 23.678 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Lack of efficacy (endoparasite) - heartworm
Outcomes: Ongoing

Dog, ['Shih Tzu', 'Poodle (unspecified)'], Female, 1.33 year, 5.98 kilogram • Drug: MSK, Unknown • Reactions: Uncomfortable, Hives, Scratching, Anaphylaxis, Facial swelling (possible allergy)… • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-017856
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Female
  • Age: 1.33 Year
  • Weight: 5.980 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Uncomfortable Hives Scratching Anaphylaxis Facial swelling (possible allergy) Diarrhea Haemorrhagic diarrhoea Not eating Loose stool Decreased bowel movements Tiredness (lethargy) Pinnal erythema Behavioral disorder (unspecified) Digestive tract disorder NOS
Outcomes: Outcome Unknown

Dog, Alaskan Klee Kai, Female, 14 year, 5.443 kilogram • Drug: MSK, Tablet, Oral, Dose: 0 per unknown • Reactions: Diarrhea • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2024-US-078231
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 14.00 Year
  • Weight: 5.443 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 0 per unknown
Reactions Reported:
Diarrhea
Outcomes: Outcome Unknown

Dog, ['Poodle (unspecified)', 'Retriever - Labrador'], Female, 10 year, 22.3 kilogram • Drug: MSK • Reactions: Lack of efficacy (fungi) - NOS • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2024-US-055123
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 10.00 Year
  • Weight: 22.300 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
Reactions Reported:
Lack of efficacy (fungi) - NOS
Outcomes: Ongoing

Cat, Cat (unknown), Unknown • Drug: MSK, Suspension, Unknown • Reactions: Death • Outcome: Died

  • Report ID: USA-USFDACVM-2022-US-033402
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Unknown
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Suspension
Reactions Reported:
Death
Outcomes: Died

Cat, Domestic Shorthair, Female, 17 year • Drug: MSK, Tablet, Oral, Dose: 1 tablet per unknown • Reactions: Lack of efficacy (ectoparasite) - flea • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2021-US-029231
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 17.00 Year
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 1 tablet per unknown
Reactions Reported:
Lack of efficacy (ectoparasite) - flea
Outcomes: Outcome Unknown

Cat, Domestic Longhair, Female, 9 year, 3.856 kilogram • Drug: MSK, Suspension, Subcutaneous, Dose: 1 dose per unknown, Frequency: 6 per month • Reactions: Injection site swelling, Injection site abscess, Purulent lesion, Injection site mucopurulent discharge • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2021-US-027911
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 9.00 Year
  • Weight: 3.856 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Subcutaneous
  • Form: Suspension
  • Dose: 1 dose per unknown
  • Frequency: 6 per month
Reactions Reported:
Injection site swelling Injection site abscess Purulent lesion Injection site mucopurulent discharge
Outcomes: Recovered/Normal

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Overdose Information

No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.

Storage & Handling

No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.

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