Prescription medicine
Acetic acid
Acetic acid is a prescription medicine. FDA's NDC Directory lists it from 4 generic labelers, and pharmacies paid $1.49 per mL (Acetic acid 2% ear solution) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the acetic acid FDA label on DailyMed (effective July 15, 2024); every acetic acid label on DailyMed.
Highlights of the record
FDA label of July 15, 2024; 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.
Forms and strengths
- 0.25 g/100ml
- 20 mg/ml
- 20.65 mg/ml
- 250 mg/100ml
Solution; irrigant.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 6 of which 4 under generic applications, 3 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $1.49 per mL Acetic acid 2% ear solution
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2012 0 Class I among all firms' recalls; latest December 15, 2017; 1 more by firms not listed as its makers
- FAERS reports
- 345 through July 30, 2026
What is acetic acid 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.
Source: FDA drug label (Acetic Acid), NuCare Pharmaceuticals,Inc., effective July 15, 2024 (SPL set 7470a1ed-bc00-cb52-e053-2a91aa0a5c7d), via openFDA; the full label on DailyMed
Is there a generic for acetic acid?
No generic acetic acid is approved (Drugs@FDA, October 8, 2026).
FDA's NDC Directory lists acetic acid from 4 labelers under a generic (ANDA) application and from 3 brand labelers. 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?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.49 per mL (Acetic acid 2% ear solution), about the same as a year earlier. 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.
- Acetic acid 2% ear solution (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Acetic acid 2% ear solution | Generic | $1.49 per mL | n/a | no change |
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 been recalled?
The FDA's Enforcement Report lists 2 recalls naming acetic acid since 2012: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of acetic acid and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| December 15, 2017 | Class II | B. Braun Medical Inc | Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap |
| May 25, 2012 | Class II | Franck's Lab Inc., d.b.a. Franck's Compounding Lab not a listed maker | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the acetic acid label say about other medicines?
The acetic acid label names no other medicine on this site. The labels of 4 other medicines name acetic acid. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name acetic acid
Source: FDA drug label (Acetic Acid), NuCare Pharmaceuticals,Inc., effective July 15, 2024 (SPL set 7470a1ed-bc00-cb52-e053-2a91aa0a5c7d), via openFDA; the full label on DailyMed
What do FAERS reports show for acetic acid?
The FDA Adverse Event Reporting System holds 345 reports that list acetic acid among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 28 are coded as a death and 125 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?
- Acetic acid side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other