Prescription medicine
Naftifine First approved as Naftin
Naftifine (Naftin) is a prescription medicine with an FDA approval on record since 1988. FDA's NDC Directory lists it from 1 generic labeler, and pharmacies paid $2.00 per gram (Naftifine HCl 2% cream) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the naftifine FDA label on DailyMed (effective July 30, 2025, Legacy Pharma USA Inc.); the NDA 19599 record on Drugs@FDA; every naftifine label on DailyMed.
Highlights of the record
FDA label of July 30, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageNAFTIN ® Gel is an allylamine antifungal indicated for the treatment of interdigital tinea pedis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum.
Forms and strengths
- 2 g/100g
- 10 mg/g
- 20 mg/g
Gel; cream.
On the market
- Earliest approval on file
- February 29, 1988 Naftin, Legacy; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first January 6, 2016; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 1 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- January 31, 2033 Naftin gel; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $2.00 per gram Naftifine HCl 2% cream
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2022 0 Class I among all firms' recalls; latest July 11, 2022
- FAERS reports
- 334 through July 30, 2026
What is naftifine used for?
From the label: indications and usageNAFTIN ® Gel is an allylamine antifungal indicated for the treatment of interdigital tinea pedis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum. NAFTIN ® Gel is an allylamine antifungal indicated for the treatment of interdigital tinea pedis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum.
Conditions named in the indications of naftifine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Allylamine Antifungal.
Source: FDA drug label (Naftin), Legacy Pharma USA Inc., effective July 30, 2025 (SPL set 6c6ee055-4031-45a7-8561-ccd989343580), via openFDA; the full label on DailyMed
Is there a generic for naftifine (Naftin)?
The FDA approved the first generic naftifine on January 6, 2016. 6 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists naftifine from 1 labeler under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 6 patents for Naftin gel, the last expiring on January 31, 2033. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1988 earliest approval on file
- 2016 first generic approved
- 2033 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 naftifine (Naftin)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $2.00 per gram (Naftifine HCl 2% cream), down 5% from $2.10 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.
- Naftifine HCl 2% cream (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Naftifine HCl 1% cream | Generic | $4.19 per gram | n/a | -12% |
| Naftifine HCl 2% cream | Generic | $2.00 per gram | n/a | -5% |
| Naftifine HCl 2% gel | Generic | $8.76 per gram | n/a | +16% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has naftifine been recalled?
The FDA's Enforcement Report lists 1 recall naming naftifine since 2022: 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 |
|---|---|---|---|
| July 11, 2022 | Class II | Tolmar, Inc. | Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for naftifine?
The FDA Adverse Event Reporting System holds 334 reports that list naftifine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 12 are coded as a death and 68 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 naftifine?
18 other medicines are given the same way (topical) and in the same FDA class as naftifine or labeled mainly for the same use (fungal infections), the same class first. Fungal infections lists all 33 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 |
|---|---|---|---|---|
| Terbinafine | Fungal infections | 20 labelers | $0.353 per gram 1% cream | No current entry |
| Tolnaftate | Fungal infections | none listed | $0.119 per gram 1% cream | No current entry |
| Clotrimazole | Fungal infections | 13 labelers | $0.133 per gram 1% topical cream | No current entry |
| Miconazole | Fungal infections | none listed | $0.120 per gram 2% topical cream | No current entry |
| Undecylenic acid | Fungal infections | none listed | n/a | No current entry |
| Ketoconazole | Fungal infections | 25 labelers | $0.249 per gram 2% cream | No current entry |
| Selenium sulfide | Fungal infections | 1 labeler | $0.0141 per mL 1% shampoo | No current entry |
| Ciclopirox | Fungal infections | 14 labelers | $0.169 per gram 0.77% cream | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to naftifine
- 18 medicines for the same use
- Other allylamine antifungals
- the pharmacologic class, with prices and generics
- Naftifine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other