Medicine
Sulfamylon 8.5% cream
Sulfamylon 8.5% cream is a prescription medicine containing Mafenide for topical use, marketed by Rising Pharma Holdings, 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.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Tube (56.7 g) - NDC 16571-723-60 Avoid exposure to excessive heat (temperature…
Key facts
- Active ingredient (INN)
- Mafenide
- Brand
- Sulfamylon
- Strength
- 8.5%
- Dosage form
- Cream
- Route
- Topical
- Packs
- 1 tube, 453.6 g
- Marketing authorisation holder
- Rising Pharma Holdings
- Manufacturer
- Rising Pharma Holdings
- Origin register
- US FDA, United States
- Storage
- Tube (56.7 g) - NDC 16571-723-60 Avoid exposure to excessive heat (temperature above 104° F or 40° C).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- D06BA03 Mafenide
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 18 May 2020
- Identifiers
- RxCUI 201185, 311406DailyMed set ID 008eaa23-8f19-4e39-85ff-540c1c834a9eNDC 16571-723Application NDA016763
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 tube in 1 carton / 113.4 g in 1 tube | 16571-723-12 | Rising Pharma Holdings | 18 May 2020 |
| 453.6 g in 1 jar | 16571-723-48 | Rising Pharma Holdings | 18 May 2020 |
| 1 tube in 1 carton / 56.7 g in 1 tube | 16571-723-60 | Rising Pharma Holdings | 18 May 2020 |
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 24 January 1969 | 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
Clinical summary
Mafenide is a methylated sulfonamide antibacterial indicated for adjunctive therapy of patients with second- and third-degree burns. It is available as cream for topical use. MedsAcross supplies Mafenide 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 MafenideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- SULFAMYLON prescribing information (Rising Pharma Holdings) · U.S. National Library of Medicine, DailyMed
Need Sulfamylon 8.5% cream 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.