Quick answers
- What is Acetic acid used for?
- The FDA-approved label (Acetic Acid, NuCare Pharmaceuticals,Inc., July 15, 2024) says: “For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Acetic acid have a boxed warning?
- No. None of the 7 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Acetic acid?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Acetic acid been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started December 15, 2017 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Acetic acid?
- 6 companies list prescription products of Acetic acid in the FDA NDC Directory, including NuCare Pharmaceuticals, Inc., Baxter Healthcare Corporation and Chartwell RX, LLC.
What 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.
— FDA label: Acetic Acid, NuCare Pharmaceuticals,Inc., effective July 15, 2024. Read the full label on DailyMed →
The FDA has 7 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 7 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Solution · Irrigant |
|---|---|
| Route | Auricular (otic) · Irrigation |
| Prescription products | 7 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 solution | Generic | $1.48 per mL |
| acetic acid 20.65 mg/mL solution | Generic | $1.48 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.
- NuCare Pharmaceuticals, Inc.2 products
- Baxter Healthcare Corporation1 product
- Chartwell RX, LLC1 product
- TruPharma, LLC1 product
- A-S Medication Solutions1 product
- B. Braun Medical 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 |
|---|---|---|---|
| NDA012179 VOSOL | Hikma | May 17, 1960 | 11, latest October 16, 1997 1997: Manufacturing (CMC) · 1997: Labeling · 1995: Manufacturing (CMC) |
| NDA018161 ACETIC ACID 0.25% IN PLASTIC CONTAINER | B Braun | August 6, 1979 | 20, latest May 15, 2003 2003: Labeling · 2002: Manufacturing (CMC) · 2002: Manufacturing (CMC) |
| NDA018523 ACETIC ACID 0.25% IN PLASTIC CONTAINER | Baxter Hlthcare | February 19, 1982 | 13, latest September 26, 2014 2014: Manufacturing (CMC) · 2011: Manufacturing (CMC) · 1999: Labeling |
Generic approvals (2)
- ANDA040166Chartwell Rx · July 26, 1996
- ANDA040607Sciegen Pharms · February 24, 2005
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.
-
December 15, 2017 · Class II · Terminated · D-0112-2018
Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap
0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA 92614-5895 USA, NDC 0264-2304-10 — B. Braun Medical 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) | 197305, 307707 |
|---|---|
| SPL set ID of the quoted label | 7470a1ed-bc00-cb52-e053-2a91aa0a5c7d |
| FDA labels (SPL) | 7 |
| FDA applications | NDA012179, NDA018161, NDA018523, 2 ANDA |
| Active ingredients (FDA) | ACETIC ACID |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Acetic Acid, NuCare Pharmaceuticals,Inc., effective July 15, 2024; 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 →