Medicine
Benzoyl peroxide and Clindamycin 37.5 mg/10 mg per g gel
Benzoyl peroxide and Clindamycin 37.5 mg/10 mg per g gel is a generic prescription medicine for topical use, made by 4 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Do not freeze.” Storage and Handling • PHARMACIST: Prior to Dispensing: Store…
Key facts
- Active ingredient (INN)
- Benzoyl peroxide and Clindamycin
- Brand
- Sold under the generic name
- Strength
- 37.5 mg/10 mg per g
- Dosage form
- Gel
- Route
- Topical
- Packs
- 50 g, 1 bottle and 1 more
- Manufacturers
- Bryant Ranch PrepackMayne PharmaOceanside PharmaceuticalsPadagis Israel Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Do not freeze.” Storage and Handling • PHARMACIST: Prior to Dispensing: Store in a refrigerator, 2°C to 8°C (36°F to 46°F). • PATIENT: After Dispensing: Discard unused portion 8 weeks after date of dispensing. Store at room temperature at or below 25°C (77°F). • Protect from freezing. • Store pump upright. • Keep out of the reach of children. Store at room temperature up to 25°C (77°F).
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 2 October 2023
- Identifiers
- RxCUI 1598470DailyMed set ID 2dfc025a-8eac-4e05-a1fe-dc22914002bb, c7381600-2e4c-4e7b-aa67-fe7d5fae7b40, 1d53ec2b-d33d-4245-99f1-e41b30303660 +1NDC 45802-383, 68308-127, 68682-133 +1Application ANDA209610, NDA050819
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 50 g in 1 bottle, pump | 68308-127-50 | Mayne Pharma | 1 October 2025 |
| 1 bottle, pump in 1 carton / 50 g in 1 bottle, pump | 68682-133-50 | Oceanside Pharmaceuticals | 2 October 2023 |
| 50 g in 1 bottle, pump | 45802-383-01 | Padagis Israel Pharmaceuticals | 20 September 2024 |
| 50 g in 1 bottle, pump | 72162-2419-2 | Bryant Ranch Prepack | 11 November 2024 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 21 December 2000 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Benzoyl peroxide and Clindamycin 37.5 mg/10 mg per g gel.
Other strengths and forms of Benzoyl peroxide and Clindamycin
Clinical summary
Benzoyl peroxide and Clindamycin is a fixed-dose combination medicine indicated for the topical treatment of acne vulgaris in patients 12 years of age and older, among other approved uses. MedsAcross supplies Benzoyl peroxide and Clindamycin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Benzoyl peroxide and ClindamycinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Clindamycin Phosphate and Benzoyl Peroxide prescribing information (Oceanside Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Benzoyl peroxide and Clindamycin 37.5 mg/10 mg per g gel for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.