On this page
Acetic Acid
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryRegulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 040607-001 | ACETIC ACID | SOLUTION/DROPS | ACETIC ACID, GLACIAL | Prescription | AT | RS |
Therapeutic equivalence
Source: Orange BookWhat this rating means: Therapeutically equivalent — bioequivalence demonstrated (topical dermatological products)
Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 6 | Labeling | Approved | June 14, 2024 | Standard |
| Original application | 1 | Approved | February 24, 2005 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260318). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingINDICATIONS AND USAGE For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial.
Dosage and Administration
openFDA Drug LabelingDOSAGE AND ADMINISTRATION Carefully remove all cerumen and debris to allow acetic acid otic solution to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with acetic acid otic solution 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 drops to 5 drops of acetic acid otic solution every 4 hours to 6 hours. The wick may be removed after 24 hours but the patient should continue to instill 5 drops of acetic acid otic solution 3 times or 4 times daily thereafter, for as long as indicated. In pediatric patients, 3 drops to 4 drops may be sufficient due to the smaller capacity of the ear canal.
Contraindications
openFDA Drug LabelingCONTRAINDICATIONS Hypersensitivity to acetic acid otic solution or any of the ingredients. Perforated tympanic membrane is considered a contraindication to the use of any medication in the external ear canal.
Warnings
openFDA Drug LabelingWARNINGS Discontinue promptly if sensitization or irritation occurs.
Adverse Reactions
openFDA Drug LabelingADVERSE REACTIONS 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 1800-FDA-1088 or www.fda.gov/medwatch.
Description
openFDA Drug LabelingDESCRIPTION Acetic Acid Otic Solution, USP is a colorless to pale yellow color nonaqueous solution of glacial acetic acid (2%), in a propylene glycol vehicle containing benzethonium chloride, propylene glycol diacetate, and sodium acetate trihydrate. It may also contain citric acid anhydrous. The molecular formula for acetic acid is CH 3 COOH, with a molecular weight of 60.05. The structural formula is: Acetic Acid Otic Solution, USP is available as a nonaqueous otic solution buffered at pH 3 for use in the external ear canal. image description
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Acetic Acid Otic Solution, USP, 2% is a colorless to pale yellow color solution supplied in 15 mL bottle with dropper plug and extended TIP closure. They are available as follows: Bottle of 15 mL – NDC 62135-801-51
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: ACETIC ACID. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 50090-6527-0 | 50090-6527 | A-S Medication Solutions | 1 BOTTLE in 1 CARTON (50090-6527-0) / 15 mL in 1 BOTTLE | June 15, 2023 |
| 62135-801-51 | 62135-801 | Chartwell RX, LLC | 15 mL in 1 BOTTLE (62135-801-51) | March 25, 2024 |
| 68071-1739-5 | 68071-1739 | NuCare Pharmaceuticals,Inc. | 15 mL in 1 BOTTLE (68071-1739-5) | August 27, 2018 |
| 68071-2984-5 | 68071-2984 | NuCare Pharmaceuticals,Inc. | 1 BOTTLE in 1 CARTON (68071-2984-5) / 15 mL in 1 BOTTLE | April 19, 2023 |
| 52817-816-15 | 52817-816 | TruPharma, LLC | 1 BOTTLE in 1 CARTON (52817-816-15) / 15 mL in 1 BOTTLE | June 1, 2020 |
| 50090-6527 | 50090-6527 | A-S Medication Solutions | — | June 1, 2020 |
| 62135-801 | 62135-801 | Chartwell RX, LLC | — | July 26, 1996 |
| 68071-1739 | 68071-1739 | NuCare Pharmaceuticals,Inc. | — | January 22, 2010 |
| 68071-2984 | 68071-2984 | NuCare Pharmaceuticals,Inc. | — | June 5, 2020 |
| 52817-816 | 52817-816 | TruPharma, LLC | — | June 1, 2020 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Orange Book | FDA | Therapeutic equivalence codes, reference drug flags, patents, exclusivity |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 11 sections on this page.