Prescription and over-the-counter medicine
Benzoyl peroxide Brand names: Epsolay
Benzoyl peroxide (Epsolay) is a prescription and over-the-counter medicine with an FDA approval on record since 2022. No generic is listed; pharmacies paid $0.0469 per gram (Benzoyl peroxide 10% wash) in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the benzoyl peroxide FDA label on DailyMed (effective July 31, 2026); the NDA 214510 record on Drugs@FDA; every benzoyl peroxide label on DailyMed.
Highlights of the record
FDA label of July 31, 2026; 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 acne
Forms and strengths
- 30 mg/g
Cream.
On the market
- Earliest approval on file
- April 22, 2022 Epsolay, Mayne Pharma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included; 100 more under the over-the-counter monograph, without an application
- Last listed patent
- May 23, 2041 Epsolay cream; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0469 per gram Benzoyl peroxide 10% wash
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2021 0 Class I among all firms' recalls; 4 more by firms not listed as its makers
- FAERS reports
- 6,709 through July 30, 2026
What is benzoyl peroxide used for?
From the label: indications and usagefor the treatment of acne
Conditions named in the indications of benzoyl peroxide's FDA labels, with every medicine labeled for each:
From other benzoyl peroxide labelsAcne: Use for the treatment of acne
Source: FDA drug label (Terminator 10), AcneFree, LLC, effective July 31, 2026 (SPL set c06778b6-0ed6-7d82-e053-2a95a90a2ef8), via openFDA; the full label on DailyMed
What does the patient leaflet for benzoyl peroxide say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while using EPSOLAY?Avoid using EPSOLAY on skin areas with cuts, abrasions, eczema, or on sunburned skin. Limit your time in sunlight. Avoid sunlight or artificial sunlight such as sunlamps or tanning beds. EPSOLAY may make your skin more sensitive to the sun and the light from sunlamps and tanning beds. Use sun protection measures such as sunscreen and wear loose-fitting clothes that cover your skin while out in sunlight. Stop using EPSOLAY if you get sunburn. Avoid getting EPSOLAY in your hair or on colored fabric. EPSOLAY may bleach hair or colored fabric.
From the patient leaflet: How should I store EPSOLAY ?Store EPSOLAY at room temperature between 68°F to 77°F (20°C to 25°C). Keep EPSOLAY away from heat. Do not freeze EPSOLAY Throw away (discard) unused EPSOLAY 60 days after first use. Keep EPSOLAY and all medicines out of the reach of children.
Source: FDA drug label (Epsolay), Mayne Pharma Commercial LLC, effective August 11, 2025 (SPL set 641981e6-460b-44dd-8146-306c47e5367c), via openFDA; the full label on DailyMed
Is there a generic for benzoyl peroxide (Epsolay)?
No generic benzoyl peroxide is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 14 patents for Epsolay cream, the last expiring on May 23, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2022 earliest approval on file
- 2041 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for benzoyl peroxide (Epsolay)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0469 per gram (Benzoyl peroxide 10% wash), up 5% from $0.0448 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.
- Benzoyl peroxide 5% wash (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Acne medication 10% gel | Generic | $0.0843 per gram | n/a | -2% |
| Acne medication 5% gel | Generic | $0.151 per gram | n/a | +6% |
| Benzoyl peroxide 10% gel | Generic | $0.231 per gram | n/a | +22% |
| Benzoyl peroxide 10% wash | Generic | $0.0469 per gram | n/a | +5% |
| Benzoyl peroxide 2.5% gel | Generic | $0.201 per gram | n/a | +4% |
| Benzoyl peroxide 5% gel | Generic | $0.217 per gram | n/a | +12% |
| Benzoyl peroxide 5% wash | Generic | $0.0403 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 benzoyl peroxide been recalled?
The FDA's Enforcement Report lists 4 recalls naming benzoyl peroxide since 2021: 0 Class I (the most serious), 4 Class II, 0 Class III; 1 still ongoing. 4 of them are by firms that FDA's NDC Directory does not list as a maker of benzoyl 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 |
|---|---|---|---|
| February 24, 2025 | Class II | Denison Pharmaceuticals, LLC not a listed maker | Chemical Contamination: Presence of benzene. |
| March 15, 2021 | Class II | Cardinal Health Inc. not a listed maker | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the benzoyl peroxide label say about other medicines?
The benzoyl peroxide label names no other medicine on this site. The labels of 3 other medicines name benzoyl peroxide. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name benzoyl peroxide
Source: FDA drug label (Terminator 10), AcneFree, LLC, effective July 31, 2026 (SPL set c06778b6-0ed6-7d82-e053-2a95a90a2ef8), via openFDA; the full label on DailyMed
What do FAERS reports show for benzoyl peroxide?
The FDA Adverse Event Reporting System holds 6,709 reports that list benzoyl peroxide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 53 are coded as a death and 382 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. Reports rose sharply in 2020 (2,010, against a median of 274 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as benzoyl peroxide?
9 other medicines are given the same way (topical) and in the same FDA class as benzoyl peroxide or labeled mainly for the same use (acne), the same class first. Acne lists all 26 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (topical) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Salicylic acid | Acne | none listed | $0.102 per patch Callus removers patch | No current entry |
| Sulfur | Acne | none listed | n/a | No current entry |
| Tretinoin | Acne | 19 labelers | $0.506 per gram 0.025% cream | No current entry |
| Adapalene | Acne | 34 labelers | $0.504 per gram 0.3% gel | No current entry |
| Dapsone | Acne | 16 labelers | $0.664 per gram 5% gel | A presentation being discontinued |
| Azelaic acid | Acne | 5 labelers | $0.441 per gram 15% gel | No current entry |
| Clindamycin and tretinoin | Acne | 3 labelers | $3.91 per gram 1.2%-0.025% | No current entry |
| Clascoterone | Acne | none listed | $10.00 per gram 1% cream | No current entry |
Every medicine labeled for the same conditions as benzoyl peroxide
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does benzoyl peroxide compare with medicines for the same use?
8 side-by-side pages set benzoyl peroxide beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to benzoyl peroxide
- 9 medicines for the same use
- Benzoyl peroxide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other