Prescription medicine
Adapalene and benzoyl peroxide and clindamycin Brand names: Cabtreo
Adapalene and benzoyl peroxide and clindamycin (Cabtreo) is a prescription medicine with an FDA approval on record since 2023. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the adapalene and benzoyl peroxide and clindamycin FDA label on DailyMed (effective April 24, 2025, Bausch Health US LLC); the NDA 216632 record on Drugs@FDA; every adapalene and benzoyl peroxide and clindamycin label on DailyMed.
Highlights of the record
FDA label of April 24, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageCABTREO is indicated for the topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older.
Forms and strengths
- 12 mg/g / 31 mg/g / 1.5 mg/g
Gel.
On the market
- Earliest approval on file
- October 20, 2023 Cabtreo, Bausch; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- Last listed patent
- December 28, 2040 Cabtreo gel; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2024 0 Class I among all firms' recalls; latest February 12, 2024
- FAERS reports
- 52 through July 30, 2026
What is adapalene and benzoyl peroxide and clindamycin used for?
From the label: indications and usageCABTREO is indicated for the topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older. CABTREO is a combination of clindamycin phosphate (a lincosamide antibacterial), adapalene (a retinoid), and benzoyl peroxide indicated for the topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older.
Conditions named in the indications of adapalene and benzoyl peroxide and clindamycin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Lincosamide Antibacterial and Retinoid.
Source: FDA drug label (Cabtreo), Bausch Health US LLC, effective April 24, 2025 (SPL set 9468da0f-9978-4c58-8135-0274c3415084), via openFDA; the full label on DailyMed
What does the patient leaflet for adapalene and benzoyl peroxide and clindamycin 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 during treatment with CABTREO?Avoid or limit your time in sunlight, including use of tanning beds or sunlamps during treatment with CABTREO. CABTREO can make you more sensitive to the sun, and the light from sunlamps and tanning beds. You could get severe sunburn. Use sunscreen and wear wide-brimmed hat and clothes that cover the treated area of your skin if you have to be in sunlight. Cold weather and wind may irritate skin treated with CABTREO. Avoid applying CABTREO to areas with skin problems, including cuts, abrasions, sunburn, or eczema. Avoid skin products that may dry or irritate your skin such as medicated or harsh soaps, astringents, cosmetics that make your skin dry, and products containing high levels of alcohol, spices, or limes. Avoid the use of “waxing” as a hair removal method on skin treated with CABTREO. Avoid getting CABTREO in your hair or on colored fabric. […]
From the patient leaflet: How should I store CABTREO?Store CABTREO at room temperature at or below 77°F (25°C). Do not freeze CABTREO. Keep CABTREO away from heat. Store CABTREO pump upright. Throw away (discard) CABTREO that has passed the expiration date. Keep CABTREO and all medicines out of the reach of children.
Source: FDA drug label (Cabtreo), Bausch Health US LLC, effective April 24, 2025 (SPL set 9468da0f-9978-4c58-8135-0274c3415084), via openFDA; the full label on DailyMed
Is there a generic for adapalene and benzoyl peroxide and clindamycin (Cabtreo)?
No generic adapalene and benzoyl peroxide and clindamycin is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 9 patents for Cabtreo gel, the last expiring on December 28, 2040. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2023 earliest approval on file
- 2040 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has adapalene and benzoyl peroxide and clindamycin been recalled?
The FDA's Enforcement Report lists 1 recall naming adapalene and benzoyl peroxide and clindamycin since 2024: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 12, 2024 | Class II | MCKESSON CORPORATION | CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the adapalene and benzoyl peroxide and clindamycin label say about other medicines?
The adapalene and benzoyl peroxide and clindamycin label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Atropine | warnings and precautions | Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen severe colitis. |
| Lincomycin | contraindications | CONTRAINDICATIONS CABTREO is contraindicated in patients with: Known hypersensitivity to clindamycin, adapalene, benzoyl peroxide, any other components of CABTREO, or lincomycin [ see Warnings and Precautions ( 5.1 )]. |
Check adapalene and benzoyl peroxide and clindamycin against other medicines
Source: FDA drug label (Cabtreo), Bausch Health US LLC, effective April 24, 2025 (SPL set 9468da0f-9978-4c58-8135-0274c3415084), via openFDA; the full label on DailyMed
What do FAERS reports show for adapalene and benzoyl peroxide and clindamycin?
The FDA Adverse Event Reporting System holds 52 reports that list adapalene and benzoyl peroxide and clindamycin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 0 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 else is labeled for the same conditions as adapalene and benzoyl peroxide and clindamycin?
8 other medicines are given the same way (topical) and in the same FDA class as adapalene and benzoyl peroxide and clindamycin or labeled mainly for the same use (acne), the same class first. Acne lists all 26 medicines labeled for it, by any route. 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 |
|---|---|---|---|---|
| Tretinoin | Acne | 19 labelers | $0.506 per gram 0.025% cream | No current entry |
| Tazarotene | Acne | 6 labelers | $6.11 per gram 0.1% gel | No current entry |
| Trifarotene | Acne | none listed | $16.36 per gram 0.005% cream | No current entry |
| Salicylic acid | Acne | none listed | $0.102 per patch Callus removers patch | No current entry |
| Sulfur | Acne | none listed | n/a | 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 |
| Clascoterone | Acne | none listed | $10.00 per gram 1% cream | No current entry |
Every medicine labeled for the same conditions as adapalene and benzoyl peroxide and clindamycin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to adapalene and benzoyl peroxide and clindamycin
- 8 medicines for the same use
- Other lincosamide antibacterials
- the pharmacologic class, with prices and generics
- Adapalene and benzoyl peroxide and clindamycin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other