Prescription medicine
Mafenide Brand names: Sulfamylon
Mafenide (Sulfamylon) is a prescription medicine with an FDA approval on record since 1969. No generic is listed; pharmacies paid $1.23 per gram (Sulfamylon 8.5% cream) in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the mafenide FDA label on DailyMed (effective July 3, 2023, Rising Pharma Holdings, Inc.); the NDA 16763 record on Drugs@FDA; every mafenide label on DailyMed.
Highlights of the record
FDA label of July 3, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageSULFAMYLON Cream is a topical agent indicated for adjunctive therapy of patients with second- and third-degree burns.
Forms and strengths
- 85 mg/g
Cream.
On the market
- Earliest approval on file
- January 24, 1969 Sulfamylon, Rising; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first February 12, 2013; 0 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $1.23 per gram Sulfamylon 8.5% cream
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2015 0 Class I among all firms' recalls; latest February 12, 2015
- FAERS reports
- 31 through July 30, 2026
What is mafenide used for?
From the label: indications and usageSULFAMYLON Cream is a topical agent indicated for adjunctive therapy of patients with second- and third-degree burns.
FDA pharmacologic class: Methylated Sulfonamide Antibacterial.
Source: FDA drug label (SULFAMYLON), Rising Pharma Holdings, Inc., effective July 3, 2023 (SPL set 008eaa23-8f19-4e39-85ff-540c1c834a9e), via openFDA; the full label on DailyMed
Is there a generic for mafenide (Sulfamylon)?
The FDA approved the first generic mafenide on February 12, 2013. 2 generic applications are approved; 0 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
- 1969 earliest approval on file
- 2013 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for mafenide (Sulfamylon)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.23 per gram (Sulfamylon 8.5% cream), about the same as a year earlier. 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.
- Sulfamylon 8.5% cream (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Sulfamylon 8.5% cream | Brand | $1.23 per gram | n/a | +0.7% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has mafenide been recalled?
The FDA's Enforcement Report lists 1 recall naming mafenide since 2015: 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, 2015 | Class II | Par Pharmaceutical Inc. | Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for mafenide?
The FDA Adverse Event Reporting System holds 31 reports that list mafenide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4 are coded as a death and 11 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?
- Mafenide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other