Meds A-Z

Hydrocortisone Aceponate

Detailed information about Hydrocortisone Aceponate

Official label facts Owner quick guide first Marketing clearly labeled

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Reviewed / Updated / Sources

Reviewed: Not available

Updated: February 12, 2026, 10:44 PM UTC

Sources:

FDA application profile · official_label
Medication usage source · fda_animal_drugs
openFDA case USA-USFDACVM-2022-US-059489 · adverse_reaction
FOI · document
SPL · document

Pet Owner Quick Guide

Start here first for the simple next-step summary.

Used for:

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

What to watch for:

For Otic Use in Dogs Only
Do not use in dogs with known tympanic membrane perforation
Wobbliness (1 reports)
Weight loss (1 reports)
Vomiting (1 reports)

When to call the vet:

Repeated vomiting or diarrhea.
Severe lethargy (hard to wake, very low energy).
Collapse or fainting.
Trouble breathing.
Facial swelling or hives.
Blood in vomit or stool.

Regulatory restrictions are shown in Vet View.

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?

Safety & side effects

What to watch:

For Otic Use in Dogs Only
Do not use in dogs with known tympanic membrane perforation
Wobbliness
Weight loss
Vomiting

Most reported reactions:

Wobbliness (1 reports)
Weight loss (1 reports)
Vomiting (1 reports)

When to call your vet:

Repeated vomiting or diarrhea.
Severe lethargy (hard to wake, very low energy).
Collapse or fainting.
Trouble breathing.

Talk to a Vet / Find a Vet Near You Start Symptom Intake

Data freshness: source data appears current.

Latest refresh: Mar 21, 2026, 10:05 a.m.

Data freshness

Medication catalog: Source Roxee | Refreshed Feb 12, 2026, 10:44 PM UTC
Animal Drugs @ FDA: Source FDA | Refreshed Mar 21, 2026, 10:01 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 Mar 21, 2026, 10:01 AM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).
openFDA reaction terms: Source FDA openFDA | Refreshed Mar 21, 2026, 10:05 AM UTC
openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:22 AM UTC

Image coming soon

Hydrocortisone Aceponate

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

Species: Both

Manufacturer: Not available (source)

Quick Facts

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

Species: Both

Manufacturer: Not available

Form: Otic Suspension

Identifiers:

NADA: 141330 NDC Package: 51311-360-10 NDC Product: 51311

Source metadata:

https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/141330 · official_label · FDA application profile
https://animaldrugsatfda.fda.gov · fda_animal_drugs · Medication usage source

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:

https://animaldrugsatfda.fda.gov · fda_animal_drugs · Contraindication source

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

Reported cases

Serious reports

Species represented

Grouped by Body System

Digestive (5) · Vomiting, Diarrhea, Decreased appetite Skin & allergy (4) · Localised rash, Hives, Chewing - pruritus Neurologic (2) · Unsteady walking (ataxia), Tiredness (lethargy) Behavior (1) · Behavioral disorder (unspecified) Effectiveness (2) · Lack of efficacy - NOS, Lack of efficacy (bacteria) - NOS Other (16) · Wobbliness, Weight loss, Vestibular disorder NOS

Most Reported Reactions

Body system	Cases	Species	Serious cases
Other	1	Cat	1
Other	1	Cat	1
Digestive	1	Cat	1
Other	1	Cat	1
Neurologic	1	Cat	1
Other	1	Cat	1
Neurologic	1	Cat	1
Other	1	Dog	1

Species coverage: Cat (21) Dog (9)

View detailed reaction table

Body system	Species	Seriousness	Frequency	Reports
Other	Cat	Serious	-	1
Other	Cat	Serious	-	1
Digestive	Cat	Serious	-	1
Other	Cat	Serious	-	1
Neurologic	Cat	Serious	-	1
Other	Cat	Serious	-	1
Neurologic	Cat	Serious	-	1
Other	Dog	Serious	-	1
Other	Cat	Serious	-	1
Other	Cat	Serious	-	1
Other	Dog	Serious	-	1
Skin & allergy	Dog	Serious	-	1
Effectiveness	Dog	Non-serious	-	1
Effectiveness	Cat	Serious	-	1
Other	Cat	Serious	-	1
Skin & allergy	Dog	Serious	-	1
Other	Cat	Serious	-	1
Other	Cat	Serious	-	1
Digestive	Cat	Serious	-	1
Other	Cat	Serious	-	1
Digestive	Cat	Serious	-	1
Skin & allergy	Dog	Non-serious	-	1
Other	Cat	Serious	-	1
Digestive	Cat	Serious	-	1
Digestive	Cat	Serious	-	1
Other	Dog	Non-serious	-	1
Other	Cat	Serious	-	1
Other	Cat	Serious	-	1
Skin & allergy	Dog	Unknown	-	-
Behavior	Dog	Unknown	-	-

Source metadata:

https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2022-US-059489

Documents

Owner handouts and official technical documents are grouped for faster access.

Owner handouts (0)

No owner handouts linked yet.

Official label / PI (0)

No official label or package insert links yet.

SPL (1)

Easotic® · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2210/Easotic%C2%AE

FOI (1)

UCM287927.pdf · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/889

Source metadata:

https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/889 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2210/Easotic%C2%AE · document · SPL

Veterinary reference (advanced)

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 Roxee | Refreshed Feb 12, 2026, 10:44 PM UTC
Animal Drugs @ FDA: Source FDA | Refreshed Mar 21, 2026, 10:01 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 Mar 21, 2026, 10:01 AM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).
openFDA reaction terms: Source FDA openFDA | Refreshed Mar 21, 2026, 10:05 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 14 • 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

Wobbliness (1) Weight loss (1) Vomiting (1) Vestibular disorder NOS (1) Unsteady walking (ataxia) (1) Unable to stand (1) Tiredness (lethargy) (1) Pinnal ulcer (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 & Change Log

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 Label highlights Official documents	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

FOI UCM287927.pdf

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

Easotic® (ZIP)

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.

Top Reported Reactions (openFDA)

De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).

Digestive

Vomiting (1) • Cat Diarrhea (1) • Cat Decreased appetite (1) • Cat Bloody diarrhoea (1) • Cat Blood in vomit (1) • Cat

Showing top 5 for Digestive.

Skin & allergy

Localised rash (1) • Dog Hives (1) • Dog Chewing - pruritus (1) • Dog

Showing top 5 for Skin & allergy.

Neurologic

Unsteady walking (1) • Cat Tiredness (1) • Cat

Showing top 5 for Neurologic.

Behavior

Behavioral disorder • Dog

Showing top 5 for Behavior.

Effectiveness

Lack of efficacy - NOS (1) • Dog Lack of efficacy (bacteria) - NOS (1) • Cat

Showing top 5 for Effectiveness.

Other

Wobbliness (1) • Cat Weight loss (1) • Cat Vestibular disorder NOS (1) • Cat Unable to stand (1) • Cat Pinnal ulcer (1) • Dog

Show more (11)

Not drinking (1) • Cat Mydriasis (1) • Cat Loss of hearing (1) • Dog Hypoglycaemia (1) • Cat Ear pain (1) • Cat Ear infection NOS (1) • Cat Decreased drinking (1) • Cat Bradycardia (1) • Cat Application site scratching (1) • Dog Administration error NOS (1) • Cat Abnormal radiograph finding (1) • Cat

Showing top 5 for Other.

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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Medical Disclaimer: The medication details provided on Roxee are for informational purposes only and are not a substitute for professional veterinary advice. Always consult your veterinarian about your pet's specific needs.

Hydrocortisone Aceponate

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Reviewed / Updated / Sources

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