Quick answers
- What is Hydrocortisone and acetic acid used for?
- The FDA-approved label (Hydrocortisone and Acetic Acid, Saptalis Pharmaceuticals, LLC, April 25, 2025) says: “For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial, complicated by inflammation.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Hydrocortisone and acetic acid?
- The “Adverse Reactions” section of the FDA label (Hydrocortisone and Acetic Acid, Saptalis Pharmaceuticals, LLC, April 25, 2025) begins: “Stinging or burning may be noted occasionally; local irritation has occurred very rarely. To report SUSPECTED ADVERSE REACTIONS, contact Saptalis Pharmaceuticals, LLC at 1-833-727-8254 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Hydrocortisone and acetic acid have a boxed warning?
- No. None of the 3 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Hydrocortisone and acetic acid?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Hydrocortisone and acetic acid been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started November 6, 2023 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Hydrocortisone and acetic acid?
- 3 companies list prescription products of Hydrocortisone and acetic acid in the FDA NDC Directory, including Saptalis Pharmaceuticals, LLC., Sun Pharmaceutical Industries, Inc. and Cosette Pharmaceuticals, Inc.
What Hydrocortisone and acetic acid is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial, complicated by inflammation.
— FDA label: Hydrocortisone and Acetic Acid, Saptalis Pharmaceuticals, LLC, effective April 25, 2025. Read the full label on DailyMed →
Label quoted: the one for the most common form (solution, auricular (otic)), Hydrocortisone and Acetic Acid, Saptalis Pharmaceuticals, LLC; it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 3 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 3 FDA labels for this medicine have a boxed warning.
Hydrocortisone and acetic acid side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
Stinging or burning may be noted occasionally; local irritation has occurred very rarely. To report SUSPECTED ADVERSE REACTIONS, contact Saptalis Pharmaceuticals, LLC at 1-833-727-8254 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
— FDA label: Hydrocortisone and Acetic Acid, Saptalis Pharmaceuticals, LLC, effective April 25, 2025. Read the full label on DailyMed →
Hydrocortisone and acetic acid dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
Carefully remove all cerumen and debris to allow Hydrocortisone and Acetic Acid to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with Hydrocortisone and Acetic Acid into the ear canal; the wick may also be saturated after insertion. Instruct the patient to keep the wick in for at least 24 hours and to keep it moist by adding 3 to 5 drops of Hydrocortisone and Acetic Acid every 4 to 6 hours.
Read more of this section
The wick may be removed after 24 hours but the patient should continue to instill 5 drops of Hydrocortisone and Acetic Acid 3 or 4 times daily thereafter, for as long as indicated. In pediatric patients, 3 to 4 drops may be sufficient due to the smaller capacity of the ear canal.
— FDA label: Hydrocortisone and Acetic Acid, Saptalis Pharmaceuticals, LLC, effective April 25, 2025. Read the full label on DailyMed →
When Hydrocortisone and acetic acid should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
Hypersensitivity to Hydrocortisone and Acetic Acid 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.
— FDA label: Hydrocortisone and Acetic Acid, Saptalis Pharmaceuticals, LLC, effective April 25, 2025. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Solution |
|---|---|
| Route | Auricular (otic) |
| Prescription products | 3 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| acetic acid 20 mg/mL · hydrocortisone 10 mg/mL solution | Generic | $5.90 per mL |
| acetic acid 20.75 mg/mL · hydrocortisone 10.375 mg/mL solution | Generic | $5.90 per mL |
| acetic acid 20.8 mg/mL · hydrocortisone 10.4 mg/mL solution | Generic | $5.90 per mL |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Saptalis Pharmaceuticals, LLC.1 product
- Sun Pharmaceutical Industries, Inc.1 product
- Cosette Pharmaceuticals, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA012770 VOSOL HC | Saptalis Pharms | June 23, 1961 | 19, latest December 3, 2024 2024: Labeling · 1997: Manufacturing (CMC) · 1997: Labeling |
Generic approvals (2)
- ANDA088759Taro · March 4, 1985
- ANDA040609Cosette Pharms Nc · February 6, 2006
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
November 6, 2023 · Class III · Terminated · D-0089-2024
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.
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. — Taro Pharmaceuticals Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 313786 |
|---|---|
| SPL set ID of the quoted label | d9a3597c-2c9d-46cc-818b-8bb3aa5c4f32 |
| FDA labels (SPL) | 3 |
| FDA applications | NDA012770, 2 ANDA |
| Active ingredients (FDA) | ACETIC ACID / HYDROCORTISONE |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
- Latest FDA drug recallsAll medicines, newest first
- Saptalis Pharmaceuticals, LLC.Maker or distributor
- Sun Pharmaceutical Industries, Inc.Maker or distributor
- Cosette Pharmaceuticals, Inc.Maker or distributor
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Hydrocortisone and Acetic Acid, Saptalis Pharmaceuticals, LLC, effective April 25, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →