Prescription medicine
Acetic acid and hydrocortisone
Acetic acid and hydrocortisone is a prescription medicine. FDA's NDC Directory lists it from 2 generic labelers, and pharmacies paid $5.44 per mL (Hydrocortisone 1%-acetic acid 2% ear drop) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the acetic acid and hydrocortisone FDA label on DailyMed (effective April 25, 2025); every acetic acid and hydrocortisone label on DailyMed.
Highlights of the record
FDA label of April 25, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageFor the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial, complicated by inflammation.
Forms and strengths
- 10.4 mg/ml / 20.8 mg/ml
- 20 mg/ml / 10 mg/ml
- 20.75 mg/ml / 10.375 mg/ml
Solution.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 3 of which 2 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $5.44 per mL Hydrocortisone 1%-acetic acid 2% ear drop
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2023 0 Class I among all firms' recalls; latest August 7, 2024
- FAERS reports
- 40 through July 30, 2026
What is acetic acid and hydrocortisone used for?
From the label: indications and usageFor the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial, complicated by inflammation.
FDA pharmacologic class: Corticosteroid.
Source: FDA drug label (hydrocortisone and acetic acid), Saptalis Pharmaceuticals, LLC, effective April 25, 2025 (SPL set d9a3597c-2c9d-46cc-818b-8bb3aa5c4f32), via openFDA; the full label on DailyMed
Is there a generic for acetic acid and hydrocortisone?
No generic acetic acid and hydrocortisone is approved (Drugs@FDA, October 8, 2026).
FDA's NDC Directory lists acetic acid and hydrocortisone from 2 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for acetic acid and hydrocortisone?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $5.44 per mL (Hydrocortisone 1%-acetic acid 2% ear drop), down 17% from $6.55 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Hydrocortisone 1%-acetic acid 2% ear drop (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Hydrocortisone 1%-acetic acid 2% ear drop | Generic | $5.44 per mL | n/a | -17% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has acetic acid and hydrocortisone been recalled?
The FDA's Enforcement Report lists 2 recalls naming acetic acid and hydrocortisone since 2023: 0 Class I (the most serious), 0 Class II, 2 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 7, 2024 | Class III | Taro Pharmaceuticals U.S.A., Inc. | Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the … |
| November 6, 2023 | Class III | Taro Pharmaceuticals Inc. | Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for acetic acid and hydrocortisone?
The FDA Adverse Event Reporting System holds 40 reports that list acetic acid and hydrocortisone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 10 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other corticosteroids
- the pharmacologic class, with prices and generics
- Acetic acid and hydrocortisone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other