Hydrocortisone and Acetic Acid is a prescription medicine (Corticosteroid). The sections below reproduce one FDA label for it, named under "Label". Products in other forms, strengths or from other makers have their own labels, which can differ.
- Type
- Prescription only (Rx)
- Drug class
- Corticosteroid
- Taken
- Auricular (otic)
- Label
- Sun Pharmaceutical Industries, Inc., revised July 7, 2025 · full label on DailyMed
- Generic
- No · details
What it is used for
For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial, complicated by inflammation.
Who should not take it (contraindications)
Hypersensitivity to hydrocortisone and acetic acid otic solution or any of the ingredients; herpes simplex, vaccinia and varicella. Perforated tympanic membrane is considered a contraindication to the use of any medication in the external ear canal.
Warnings
Discontinue promptly if sensitization or irritation occurs.
Precautions
Transient stinging or burning may be noted occasionally when the solution is first instilled into the acutely inflamed ear. Pediatric Use Safety and effectiveness in pediatric patients below the age of 3 years have not been established.
Side effects (adverse reactions)
Stinging or burning may be noted occasionally; local irritation has occurred very rarely.
Use in children
Safety and effectiveness in pediatric patients below the age of 3 years have not been established.
Is there a generic Hydrocortisone and Acetic Acid?
No. The FDA has not approved a generic version yet.
Source: Drugs@FDA (via openFDA), checked October 29, 2026. Marketing status is what companies report to the FDA; whether a pharmacy stocks a product, and what your insurance covers, can differ.
Dosage:
we do not reproduce dosing instructions. The right dose depends on the person and the condition and is set by the prescriber or pharmacist. Dosage section of the full label.
Hydrocortisone and acetic acid in the news
We have not covered this medicine yet. Latest news
Recalls
-
Class III Terminated
Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada LGT 1C, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532.…
Reason: Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Lots, distribution and details
- Product
- Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada LGT 1C, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC 51672-3007-1
- Lots / codes
- Lot# AC86809, AC86812, Exp Date: 01/31/2024
- Distribution
- Nationwide in the USA
- Quantity
- 11,196 bottles
- Recall started
- November 6, 2023 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0089-2024
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
Get alerts for Hydrocortisone and Acetic Acid
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Source: FDA structured product labeling, retrieved through openFDA. Label text is shown as published by the FDA, without editing; long sections are shortened, marked […]. openFDA data are not validated for clinical use — always check the current label and ask a doctor or pharmacist about your own treatment. Set ID 6383c722-84e2-4719-a13d-19c54e3eefff.