Over-the-counter medicine
Carbamide peroxide
Carbamide peroxide is an over-the-counter medicine. No generic is listed; pharmacies paid $0.162 per mL (Ear wax removal 6.5% drop) in the October 7, 2026 NADAC survey.
- No generic listed
- Over the counter
Check it at the source: the carbamide peroxide FDA label on DailyMed (effective June 10, 2026); every carbamide peroxide label on DailyMed.
Highlights of the record
FDA label of June 10, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagefor occasional use as an aid to soften, loosen, and remove excessive earwax.
Forms and strengths
- 0.065 mg/ml
- 0.065 g/ml
- 0.065 g/g
- 6.5 g/100ml
- 6.5 mg/ml
- 7.8 mg/12ml
- 65 mg/ml
- 100 mg/ml
Liquid; solution/ drops; kit; solution.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 56 of which 0 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.162 per mL Ear wax removal 6.5% drop
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2022 0 Class I among all firms' recalls; 12 more by firms not listed as its makers
- FAERS reports
- 487 through July 30, 2026
What is carbamide peroxide used for?
From the label: indications and usagefor occasional use as an aid to soften, loosen, and remove excessive earwax.
Source: FDA drug label (Quality Choice Earwax Removal Kit Earwax Removal Aid and Bulb), Chain Drug Marketing Association, Inc., effective June 10, 2026 (SPL set b2a641da-e070-4223-b836-5ca9ffb89f3f), via openFDA; the full label on DailyMed
Is there a generic for carbamide peroxide?
No generic carbamide peroxide is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for carbamide peroxide?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.162 per mL (Ear wax removal 6.5% drop), down 3% from $0.167 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.
- Ear wax removal 6.5% drop (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Ear wax removal 6.5% drop | Generic | $0.162 per mL | n/a | -3% |
| Ear wax removal 6.5% kit | Generic | $0.162 per mL | n/a | -3% |
| Ft ear wax removal 6.5% drop | Generic | $0.162 per mL | n/a | -3% |
| Ft ear wax removal 6.5% kit | Generic | $0.162 per mL | n/a | -3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has carbamide peroxide been recalled?
The FDA's Enforcement Report lists 12 recalls naming carbamide peroxide since 2022: 0 Class I (the most serious), 12 Class II, 0 Class III; 11 still ongoing. 12 of them are by firms that FDA's NDC Directory does not list as a maker of carbamide peroxide and that hold 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 |
|---|---|---|---|
| June 25, 2026 | Class II | Bell Pharmaceuticals, Inc not a listed maker | SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). |
| June 29, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office not a listed maker | CGMP Deviations: products were stored outside the drug label specifications. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for carbamide peroxide?
The FDA Adverse Event Reporting System holds 487 reports that list carbamide peroxide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 50 are coded as a death and 171 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?
- Carbamide peroxide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other