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Meds A-Z

Hydrocortisone Aceponate

Detailed information about Hydrocortisone Aceponate

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 the treatment of otitis externa in dogs associated with susceptible strains of yeast Malassezia pachydermatis and bacteria Staphylococcus pseudintermedius ).

What it does:

For the treatment of otitis externa in dogs associated with susceptible strains of yeast Malassezia pachydermatis and bacteria Staphylococcus pseudintermedius ).

When it's needed:

Federal law restricts this drug to use by or on the order of a licensed veterinarian. For Otic Use in Dogs Only. Do not use in dogs with known tympanic membrane perforation.

Call your vet sooner if you notice:

  • Federal law restricts this drug to use by or on the order of a licensed veterinarian. For Otic Use in Dogs Only. Do not use in dogs with known tympanic membrane perforation.

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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Hydrocortisone Aceponate

Hydrocortisone Aceponate

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

Species: Both

Manufacturer: MSK

Quick Facts

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

Species: Both
Manufacturer: MSK
Form: Otic Suspension
Identifiers:
NADA: 141330 NDC Package: 51311-360-10 NDC Product: 51311
Source metadata:

Warnings / Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian. For Otic Use in Dogs Only. Do not use in dogs with known tympanic membrane perforation.

  • High: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For Otic Use in Dogs Only. Do not use in dogs with known tympanic membrane perforation.
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
28
Serious reports
25
Species represented
2
Most Reported Reactions
Reaction Cases Species Serious cases
1 Cat 1
1 Cat 1
1 Cat 1
1 Cat 1
1 Dog 1
1 Cat 1
1 Cat 1
1 Dog 1

Species coverage: Cat (23) Dog (9)

View detailed reaction table
Reaction Species Seriousness Frequency Reports
Cat Serious - 1
Cat Serious - 1
Dog Non-serious - 1
Cat Serious - 1
Cat Serious - 1
Cat Serious - 1
Cat Serious - 1
Dog Non-serious - 1
Cat Serious - 1
Cat Serious - 1
Cat Serious - 1
Cat Serious - 1
Cat Serious - 1
Cat Serious - 1
Dog Serious - 1
Cat Serious - 1
Cat Serious - 1
Dog Non-serious - 1
Cat Serious - 1
Dog Serious - 1
Dog Serious - 1
Cat Serious - 1
Cat Serious - 1
Dog Serious - 1
Cat Serious - 1
Cat Serious - 1
Cat Serious - 1
Cat Serious - 1
Cat Unknown - -
Cat Unknown - -
Dog Unknown - -
Dog Unknown - -
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: 2 • Secondary summaries: 0

Official label facts
Secondary summaries

No source yet.

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, 11:05 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:22 AM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: Easotic®
Case-reported brands (openFDA): MSK
Catalog species: Both FDA-labeled species: Dog
Rx/OTC: RX
Form/route: Otic Suspension Otic
Applications: NADA 141-330
Documents: 1 (FOI: 1) • SPL: 1 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
Related conditions: Otitis Externa (Ear Infection)
Linked using: Fda_Label (0.95)

Diagnosis Codes
ICD10_CM: H60.90
Otitis externa, unspecified ear

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
  • Federal law restricts this drug to use by or on the order of a licensed veterinarian. For Otic Use in Dogs Only. Do not use in dogs with known tympanic membrane perforation. (Contraindication, High)
Top reaction signals
Abnormal radiograph finding (1) Administration error NOS (1) Application site scratching (1) Ataxia (1) Blood in vomit (1) Bloody diarrhoea (1) Bradycardia (1) Chewing - pruritus (see also Oral cavity disorders) (1) Decreased appetite (1) Decreased drinking (1) Diarrhoea (1) Ear infection NOS (1) Ear pain (1) Emesis (multiple) (1) Hives (see also Skin) (1) Hypoglycaemia (1)

Identifiers & Packages

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

Identifiers
NADA: 141330 NDC Package: 51311-360-10 NDC Product: 51311
Package NDC Product NDC Form / Route Status
51311-360-10 51311 -

Enriched Documents

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

  • UCM287927.pdf • FOI summary • Official • May 14, 2024
    FDA FOI summary for application 141330

Data Sources & Revision History

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

Official 4 Clinical 0 Manufacturer 0 Marketing 0
Current Field Facts
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For Otic Use in Dogs Only. Do not use in dogs with known tympanic membran… (Official, 2026-02-12)
  • side_effects: Top reported reactions (openFDA): Loss of hearing, Lack of efficacy - NOS, Deafness, Lack of efficacy (bacteria) - NOS, Vomiting, Pinnal erythema. (Official, 2026-02-12)
  • usage: For the treatment of otitis externa in dogs associated with susceptible strains of yeast Malassezia pachydermatis and bacteria Staphylococcus pseudintermedius … (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
Easotic®
RX
Gentamicin Sulfate Hydrocortisone aceponate Miconazole Nitrate
Otic Suspension Otic
Virbac AH, Inc. NADA 141-330 Approved May 14, 2024

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, No Use Class Stated Or Implied
Composition / specifications
1.11 mg/mL hydrocortisone aceponate, 17.4 mg/mL miconazole nitrate, 1.5 mg/mL gentamicin sulfate
Dogs
Indication
For the treatment of otitis externa in dogs associated with susceptible strains of yeast Malassezia pachydermatis and bacteria Staphylococcus pseudintermedius).
Dosage
Verify that the tympanic membrane is intact. Carefully insert the canula into the affected external ear canal(s) and apply 1 mL (a single pump) once per day for 5 days. Wash hands after usage.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. For Otic Use in Dogs Only. Do not use in dogs with known tympanic membrane perforation.

FDA page: Open in Animal Drugs @ FDA

Official Documents (FDA)

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

Documents
  • Summary
    Easotic® suspension is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis) and bacteria ( Staphylococcus pseudintermedius).
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Usage

For the treatment of otitis externa in dogs associated with susceptible strains of yeast Malassezia pachydermatis and bacteria Staphylococcus pseudintermedius ).

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian. For Otic Use in Dogs Only. Do not use in dogs with known tympanic membrane perforation.

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 (14)
Skin & allergy
Chewing - pruritus (1) Chewing - pruritus (1) Chewing - pruritus (1) Chewing - pruritus (1) Chewing - pruritus (1) Chewing - pruritus (1) Hives (1) Hives (1) Hives (1) Hives (1) Hives (1) Hives (1) Localised rash (1) Localised rash (1) Localised rash (1) Localised rash (1) Localised rash (1) Localised rash (1)
Behavior
Behavioral disorder (unspecified) (9)
Effectiveness
Lack of efficacy - NOS (44) Lack of efficacy (bacteria) - NOS (15) Lack of efficacy - NOS (1) Lack of efficacy - NOS (1) Lack of efficacy - NOS (1) Lack of efficacy - NOS (1) Lack of efficacy - NOS (1) Lack of efficacy - NOS (1)
Other
Loss of hearing (210) Deafness (18) Pinnal erythema (11) Head shake - ear disorder (10) Loss of hearing (7) Loss of hearing (7) Loss of hearing (7) Loss of hearing (7) Loss of hearing (6) Loss of hearing (6) Application site scratching (1) Application site scratching (1) Application site scratching (1) Application site scratching (1) Application site scratching (1) Application site scratching (1) Ear discharge (1) Ear discharge (1) Ear discharge (1) Ear discharge (1) Ear discharge (1) Ear discharge (1) Pinnal ulcer (1) Pinnal ulcer (1) Pinnal ulcer (1) Pinnal ulcer (1) Pinnal ulcer (1) Pinnal ulcer (1)
Cat
Digestive
Blood in vomit (2) Bloody diarrhoea (2) Decreased appetite (2) Diarrhea (2)
Other
Ear infection NOS (2) Hypoglycaemia (2) Abnormal radiograph finding (1) Administration error NOS (1)

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, ['Pit Bull', 'Dog (unknown)'], Male, 7 year, 20.865 kilogram • Drug: MSK, Suspension, Auricular (Otic), Dose: 1 dose per dose, Frequency: 1 per day • Reactions: Loss of hearing • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-055761
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Male
  • Age: 7.00 Year
  • Weight: 20.865 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Suspension
  • Dose: 1 dose per dose
  • Frequency: 1 per day
Reactions Reported:
Loss of hearing
Outcomes: Outcome Unknown

Dog, Terrier (unspecified), Female, 14 year, 6.985 kilogram • Drug: MSK, Suspension, Auricular (Otic), Dose: 1 Other per dose, Frequency: 1 per day • Reactions: Loss of hearing • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-055553
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Female
  • Age: 14.00 Year
  • Weight: 6.985 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Suspension
  • Dose: 1 Other per dose
  • Frequency: 1 per day
Reactions Reported:
Loss of hearing
Outcomes: Outcome Unknown

Dog, Chihuahua, Female, 1.5 year, 5.443 kilogram • Drug: MSK, Suspension, Auricular (Otic), Dose: 1 dose per animal, Frequency: 1 per day • Reactions: Chewing - pruritus, Application site scratching, Lack of efficacy - NOS • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-055857
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 1.50 Year
  • Weight: 5.443 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Suspension
  • Dose: 1 dose per animal
  • Frequency: 1 per day
Reactions Reported:
Chewing - pruritus Application site scratching Lack of efficacy - NOS
Outcomes: Outcome Unknown

Dog, Shepherd Dog - Australian, Male, 1.7 year, 18.688 kilogram • Drug: MSK, Suspension, Auricular (Otic), Dose: 1 dose per animal, Frequency: 1 per day • Reactions: Hives, Localised rash • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-054269
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 1.70 Year
  • Weight: 18.688 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Suspension
  • Dose: 1 dose per animal
  • Frequency: 1 per day
Reactions Reported:
Hives Localised rash
Outcomes: Recovered/Normal

Dog, Shih Tzu, Female, 8 year, 4.627 kilogram • Drug: MSK, Suspension, Auricular (Otic), Dose: 1 Other per dose, Frequency: 1 per day • Reactions: Pinnal ulcer • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-052998
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Female
  • Age: 8.00 Year
  • Weight: 4.627 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Suspension
  • Dose: 1 Other per dose
  • Frequency: 1 per day
Reactions Reported:
Pinnal ulcer
Outcomes: Recovered/Normal

Cat, Domestic Shorthair, Female, 6.1 year, 8.21 kilogram • Drug: MSK, Suspension, Auricular (Otic), Dose: 1 mL per dose, Frequency: 1 per day • Reactions: Vestibular disorder NOS, Unable to stand, Wobbliness • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2024-US-035205
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Female
  • Age: 6.10 Year
  • Weight: 8.210 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Suspension
  • Dose: 1 mL per dose
  • Frequency: 1 per day
Reactions Reported:
Vestibular disorder NOS Unable to stand Wobbliness
Outcomes: Outcome Unknown

Cat, Maine Coon, Female, 15 year, 2.722 kilogram • Drug: MSK, Suspension, Auricular (Otic), Dose: 1 Other per dose, Frequency: 1 per day • Reactions: Ear pain, Ear infection NOS, Lack of efficacy (bacteria) - NOS, Administration error NOS • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2023-US-031866
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Female
  • Age: 15.00 Year
  • Weight: 2.722 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Suspension
  • Dose: 1 Other per dose
  • Frequency: 1 per day
Reactions Reported:
Ear pain Ear infection NOS Lack of efficacy (bacteria) - NOS Administration error NOS
Outcomes: Outcome Unknown

Cat, Cat (unknown), Male, 10 year, 8.165 kilogram • Drug: MSK, Suspension, Auricular (Otic), Dose: 1 mL per animal, Frequency: 24 per hour • Reactions: Blood in vomit, Diarrhea, Decreased appetite, Decreased drinking, Bloody diarrhoea… • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2022-US-059489
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 10.00 Year
  • Weight: 8.165 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Suspension
  • Dose: 1 mL per animal
  • Frequency: 24 per hour
Reactions Reported:
Blood in vomit Diarrhea Decreased appetite Decreased drinking Bloody diarrhoea Hypoglycaemia Abnormal radiograph finding Weight loss Vomiting Ear infection NOS
Outcomes: Outcome Unknown

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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