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Naftifine Hydrochloride 20 mg/g Gel — NDC 51672-1376-3 (Billing 51672-1376-03)

by Sun Pharmaceutical Industries, Inc. · 1 TUBE in 1 CARTON / 60 g in 1 TUBE

This is a package of Naftifine Hydrochloride 20 mg/g Gel from Sun Pharmaceutical Industries, Inc., marketed since Apr 2023 and currently FDA-listed; retail pharmacies pay about $8.57 per g (NADAC).

NDC 51672-1376-03
🏷️ FDA NDC (as labeled) 51672-1376-3 billing pads the package segment with a zero
This package
Contains60 g in 1 tube Cost per g$8.57 NADAC Per package$513.91 / 60 g Pack sizes2 compare ↓
Also priced by: Medicaid pays $7.18/unit · Part D plans $7.86/unit — full pricing hub ↓
Product page 51672-1376-06 Also comes in: 45 g 51672-1376-6
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51672-1376-3
Product NDC 51672-1376
11-digit billing NDC 51672137603
NCPDP billing unit GM — per gram (weight)
RxCUI 1433734
UNII 25UR9N9041
Application # ANDA208201
SPL Set ID 92d3ec30-2176-49cd-8a70-668ef65e7663
Established class (EPC) Allylamine Antifungal
Chemical class Allylamine
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-04-01
Route TOPICAL
Dosage form GEL
Substance NAFTIFINE HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 90150078004030
GCN Seq No 071236
GCN 34933
HICL code 003204
Ingredient (HICL) Naftifine Hcl
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5F
Therapeutic class — specific (HIC3) Topical Antifungals
AHFS code 84:04.08.04
AHFS class Allylamines (Skin And Mucous Membrane)
FDB label name NAFTIFINE HCL 2% GEL
FDB brand name Naftifine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 071236
  • GCN: 34933
  • GPI-14 (Medi-Span): 90150078004030
  • HICL (First Databank): 003204
  • AHFS class code: 84:04.08.04
  • RxCUI (RxNorm): 1433734
Why two NDCs? The FDA registers this code as 51672-1376-3 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 51672-1376-03. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Allylamine Antifungal class.

Pharmacologic class Allylamine Antifungal
Drug family (ATC) Other antifungals for topical use
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name NAFTIFINE HCL 2% GEL Ingredient Naftifine Hcl
📗 Our plain-language guide HelloPharmacist
  • The gel treats athlete's foot between the toes (interdigital tinea pedis). It works against the fungi that commonly cause this infection.
  • Apply a thin layer once a day to the infected skin and a small margin of healthy skin around it. Keep going for 2 weeks. It is only for the skin, so keep it out of your eyes, mouth...
  • Itching is the most common one. Some people notice redness, irritation or burning. Most reactions are mild.
  • Stop and call your doctor if redness, irritation or sensitivity develops. Also call if you notice blisters, crusting or fluid draining from the skin.
📖 Read our full Naftifine Topical guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly $8.565 $513.91 / 60 g
Medicaid paysCMS SDUD · 12 mo $7.18 $430.67 / 60 g
Medicare drug plans payPart D · Q2 2026 $7.86 $471.49 / 60 g
NADAC price history (per g) — tap or hover for the price & month
Dec 2025 Jan 2026 Feb 2026 Mar 2026 $8.565 $8.114
▲ Up 6% over the last 4 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
51672-1376-03 You're viewing this 1 TUBE in 1 CARTON / 60 g in 1 TUBE $8.57 / g $513.91 2023-04-01 — Active
51672-1376-06 51672-1376-6 Main listing 1 TUBE in 1 CARTON / 45 g in 1 TUBE $8.95 / g $402.91 2023-04-01 — Active

This pack has the lowest per-g cost of the 2 priced pack sizes ($8.57 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 50% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 60 g in 1 tube.
What NDC number is used to bill for this package of Naftifine Hydrochloride 20 mg/g Gel?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Naftifine Hydrochloride 20 mg/gthis 51672-1376-03 Sun 1 tube $8.565 AB Availability likely —
Naftin 2 g/100g 54766-0772-45 Sebela 1 tube $10.925 AB Availability likely +28%
Naftin 2 g/100g 83107-0023-45 Legacy 1 tube $10.925 AB Availability likely +28%
Naftifine Hydrochloride 20 mg/g 51672-1368-02 Sun 1 tube — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2023
On the market since
Apr 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerSun Pharmaceutical Industries, Inc.
Application holderSUN PHARMA CANADA INC
FDA applicationANDA208201 (ANDA)
Labeler code51672
First marketedApr 2023
Product typeHuman Prescription Drug
Portfolio890 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 64 words ▾

1 INDICATIONS AND USAGE Naftifine hydrochloride gel USP, 2% is indicated for the treatment of interdigital tinea pedis caused by the organisms Trichophyton rubrum , Trichophyton mentagrophytes , and Epidermophyton floccosum . Naftifine Hydrochloride Gel USP, 2% is an allylamine antifungal indicated for the treatment of interdigital tinea pedis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum . ( 1 )

⏱️ Dosage and Administration 98 words ▾

2 DOSAGE AND ADMINISTRATION Apply a thin layer of naftifine hydrochloride gel, 2% once daily to the affected areas plus an approximate ½ inch margin of healthy surrounding skin for 2 weeks. For topical use only. Naftifine hydrochloride gel, 2% is not for ophthalmic, oral, or intravaginal use.

Apply a thin layer of naftifine hydrochloride gel, 2% once daily to the affected areas plus an approximate ½ inch margin of healthy surrounding skin for 2 weeks. ( 2 ) For topical use only. Naftifine hydrochloride gel, 2% is not for ophthalmic, oral, or intravaginal use.

( 2 )

💊 Dosage Forms and Strengths 26 words ▾

3 DOSAGE FORMS AND STRENGTHS Gel, 2%. Each gram contains 20 mg of naftifine hydrochloride in a colorless to yellow gel. Gel, 2%. ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions 43 words ▾

5 WARNINGS AND PRECAUTIONS If redness or irritation develops with the use of naftifine hydrochloride gel treatment should be discontinued. ( 5.1 )

5.1Local Adverse Reactions If irritation or sensitivity develops with the use of naftifine hydrochloride gel, treatment should be discontinued.

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS The most common adverse reactions are application site reactions (2%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In two randomized, vehicle-controlled trials, 1143 subjects were treated with naftifine hydrochloride gel versus 571 subjects treated with the vehicle. The trial subjects were 12 to 92 years old, were primarily male (76%), and were 59% Caucasian, 38% Black or African American, and 23% Hispanic or Latino.

Subjects received doses once daily, topically, for 2 weeks to cover the affected skin areas plus a ½-inch margin of surrounding healthy skin. The most common adverse reactions were application site reactions which occurred at the rate of 2% in naftifine hydrochloride gel arm versus 1% in vehicle arm. Most adverse reactions were mild in severity.

In an open-label pediatric pharmacokinetics and safety trial 22 pediatric subjects 12 to 17 years of age with interdigital tinea pedis received naftifine hydrochloride gel. The incidence of adverse reactions in the pediatric population was similar to that observed in adult population. Cumulative irritancy testing revealed the potential for naftifine hydrochloride gel to cause irritation.

There was no evidence that naftifine hydrochloride gel causes contact sensitization, phototoxicity, or photoallergenicity in healthy skin.

6.2Postmarketing Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been identified during post-approval use of naftifine hydrochloride: blisters, burning sensation, crusting, dryness, erythema/redness, inflammation, irritation, maceration, pain, pruritus [mild]/itching, rash and swelling.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no available data on naftifine hydrochloride gel use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, no adverse effects on embryofetal development were seen at oral doses administered during the period of organogenesis up to 37 times the maximum recommended human dose (MRHD) in pregnant rats or subcutaneous doses administered during the period of organogenesis up to 4 times the MRHD in pregnant rats or 7 times the MRHD in pregnant rabbits ( see Data ).

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data Animal Data Systemic embryofetal development studies were conducted in rats and rabbits. For the comparison of animal to human doses, the MRHD is set at 4 g 2% gel per day (1.33 mg/kg/day for a 60 kg individual). Oral doses of 30 mg/kg/day, 100 mg/kg/day, and 300 mg/kg/day naftifine hydrochloride were administered during the period of organogenesis to pregnant female rats.

No treatment-related effects on embryofetal toxicity were noted at doses up to 300 mg/kg/day (37 times the MRHD based on mg/m 2 comparison). Subcutaneous doses of 10 mg/kg/day and 30 mg/kg/day naftifine hydrochloride were administered during the period of organogenesis to pregnant female rats. No treatment-related effects on embryofetal toxicity were noted at 30 mg/kg/day (4 times the MRHD based on mg/m 2 comparison).

Subcutaneous doses of 3 mg/kg/day, 10 mg/kg/day, and 30 mg/kg/day naftifine hydrochloride were administered during the period of organogenesis to pregnant female rabbits. No treatment-related effects on embryofetal toxicity were noted at 30 mg/kg/day (7 times the MRHD based on mg/m 2 comparison). A peri- and post-natal development study was conducted in rats.

Oral doses of 30 mg/kg/day, 100 mg/kg/day, and 300 mg/kg/day naftifine hydrochloride were administered to female rats from gestational day 14 to lactation day 21. Reduced body weight gain of females during gestation and of the offspring during lactation was noted at 300 mg/kg/day (37 times the MRHD based on mg/m 2 comparison). No developmental toxicity was noted at 100 mg/kg/day (12 times the MRHD based on mg/m 2 comparison).

8.2Lactation Risk Summary There is no information available on the presence of naftifine hydrochloride in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production after topical application of naftifine hydrochloride gel to women who are breastfeeding. It is not known whether naftifine hydrochloride is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when naftifine hydrochloride is administered to a nursing woman.

The lack of clinical data during lactation precludes a clear determination of the risk naftifine hydrochloride gel to an infant during lactation. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for naftifine hydrochloride gel and any potential adverse effects on the breastfed infant from naftifine hydrochloride gel or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of naftifine hydrochloride gel have been established in the age group 12 to 18 years of age with interdigital tinea pedis. Use of naftifine hydrochloride gel in this age group is supported by evidence from adequate and well controlled trials in adults with additional safety and PK data from an open label trial, conducted in 22 adolescents ≥12 years of age who were exposed to naftifine h… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary There are no available data on naftifine hydrochloride gel use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, no adverse effects on embryofetal development were seen at oral doses administered during the period of organogenesis up to 37 times the maximum recommended human dose (MRHD) in pregnant rats or subcutaneous doses administered during the period of organogenesis up to 4 times the MRHD in pregnant rats or 7 times the MRHD in pregnant rabbits ( see Data ).

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data Animal Data Systemic embryofetal development studies were conducted in rats and rabbits. For the comparison of animal to human doses, the MRHD is set at 4 g 2% gel per day (1.33 mg/kg/day for a 60 kg individual). Oral doses of 30 mg/kg/day, 100 mg/kg/day, and 300 mg/kg/day naftifine hydrochloride were administered during the period of organogenesis to pregnant female rats.

No treatment-related effects on embryofetal toxicity were noted at doses up to 300 mg/kg/day (37 times the MRHD based on mg/m 2 comparison). Subcutaneous doses of 10 mg/kg/day and 30 mg/kg/day naftifine hydrochloride were administered during the period of organogenesis to pregnant female rats. No treatment-related effects on embryofetal toxicity were noted at 30 mg/kg/day (4 times the MRHD based on mg/m 2 comparison).

Subcutaneous doses of 3 mg/kg/day, 10 mg/kg/day, and 30 mg/kg/day naftifine hydrochloride were administered during the period of organogenesis to pregnant female rabbits. No treatment-related effects on embryofetal toxicity were noted at 30 mg/kg/day (7 times the MRHD based on mg/m 2 comparison). A peri- and post-natal development study was conducted in rats.

Oral doses of 30 mg/kg/day, 100 mg/kg/day, and 300 mg/kg/day naftifine hydrochloride were administered to female rats from gestational day 14 to lactation day 21. Reduced body weight gain of females during gestation and of the offspring during lactation was noted at 300 mg/kg/day (37 times the MRHD based on mg/m 2 comparison). No developmental toxicity was noted at 100 mg/kg/day (12 times the MRHD based on mg/m 2 comparison).

🧒 Pediatric Use 102 words ▾

8.4Pediatric Use The safety and effectiveness of naftifine hydrochloride gel have been established in the age group 12 to 18 years of age with interdigital tinea pedis. Use of naftifine hydrochloride gel in this age group is supported by evidence from adequate and well controlled trials in adults with additional safety and PK data from an open label trial, conducted in 22 adolescents ≥12 years of age who were exposed to naftifine hydrochloride gel at a dose of approximately 4 g/day [see Clinical Pharmacology (12.3) ] .

Safety and effectiveness in pediatric patients <12 years of age have not been established.

🧓 Geriatric Use 31 words ▾

8.5Geriatric Use During clinical trials, 99 subjects (9%) aged 65 years and over were exposed to naftifine hydrochloride gel. Safety and effectiveness were similar to those reported by younger subjects.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Naftifine hydrochloride gel is a topical antifungal drug [see Clinical Pharmacology (12.4) ] .

12.2Pharmacodynamics The pharmacodynamics of naftifine hydrochloride gel have not been established.

12.3Pharmacokinetics In vitro and in vivo bioavailability studies have demonstrated that naftifine penetrates the stratum corneum in sufficient concentration to inhibit the growth of dermatophytes. Pharmacokinetic analysis of plasma samples from 32 subjects with tinea pedis treated with a mean dose of 3.9 grams naftifine hydrochloride gel applied once daily to both feet for 14 days showed increased exposure over the treatment period, with a geometric mean (CV%) AUC 0-24 (area under plasma concentration-versus-time curve from time 0 to 24 hours) of 10.5 (118) ng∙hr/mL on Day 1 and an AUC 0-24 of 70 (59) ng∙hr/mL on Day 14.

The accumulation ratio based on AUC was approximately 6. Maximum concentration (C max ) also increased over the treatment period; geometric mean (CV%) C max after a single dose was 0.9 (92) ng/mL on Day 1; C max on Day 14 was 3.7 (64) ng/mL. Median T max was 20 hours (range: 8, 20 hours) after a single application on Day 1 and 8 hours (range: 0, 24 hours) on Day 14.

Trough plasma concentrations increased during the trial period and reached steady state after 11 days. In the same pharmacokinetic trial, the fraction of dose excreted in urine during the treatment period was less than or equal to 0.01% of the applied dose. In a second trial, the pharmacokinetics of naftifine hydrochloride gel was evaluated in 22 pediatric subjects 12 to 17 years of age with tinea pedis.

Subjects were treated with a mean dose of 4.1 grams naftifine hydrochloride gel applied to the affected area once daily for 14 days. The results showed that the systemic exposure increased over the treatment period. Geometric mean (CV%) AUC 0-24 was 15.9 (212) ng∙hr/mL on Day 1 and 60 (131) ng∙hr/mL on Day 14.

Geometric mean (CV%) C max after a single dose was 1.40 (154) ng/mL on Day 1 and 3.81 (154) ng/mL on Day 14. The fraction of dose excreted in urine during the treatment period was less than or equal to 0.003% of the applied dose.

12.4Microbiology Mechanism of Action Naftifine is an antifungal that belongs to the allylamine class. Although the exact mechanism of action against fungi is not known, naftifine hydrochloride appears to interfere with sterol biosynthesis by inhibiting the enzyme squalene 2, 3-epoxidase. The inhibition of enzyme activity by this allylamine results in decreased amounts of sterols, especially ergosterol, and a corresponding accumulation of squalene in the cells.

Mechanism of Resistance To date, a mechanism of resistance to naftifine has not been identified. Naftifine has been shown to be active against most isolates of the following fungi, both in vitro and in clinical infections, as described in the INDICATIONS AND USAGE section: Trichophyton rubrum Trichophyton mentagrophytes Epidermophyton floccosum

🧬 Mechanism of Action 18 words ▾

12.1Mechanism of Action Naftifine hydrochloride gel is a topical antifungal drug [see Clinical Pharmacology (12.4) ] .

📦 How Supplied / Storage and Handling 77 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Naftifine Hydrochloride Gel USP, 2% is a colorless to yellow gel supplied in collapsible tubes in the following size: 45g – NDC 51672-1376-6 60g – NDC 51672-1376-3 Storage Store at 20° to 25°C (68° to 77°F); [see USP Controlled Room Temperature].

How Supplied Naftifine Hydrochloride Gel USP, 2% is a colorless to yellow gel supplied in collapsible tubes in the following size: 45g – NDC 51672-1376-6 60g – NDC 51672-1376-3

📦 Storage and Handling 14 words ▾

Storage Store at 20° to 25°C (68° to 77°F); [see USP Controlled Room Temperature].

📋 Description 91 words ▾

11 DESCRIPTION Naftifine Hydrochloride Gel USP, 2% is a clear to yellow gel for topical use only. Each gram of naftifine hydrochloride gel contains 20 mg of naftifine hydrochloride, a synthetic allylamine antifungal compound. Chemically, naftifine HCl is (E)-N-Cinnamyl-N-methyl-1-napthalenemethylamine hydrochloride.

The molecular formula is C 21 H 21 N∙HCl with a molecular weight of 323.86. The structural formula of naftifine hydrochloride is: Naftifine Hydrochloride Gel USP, 2% contains the following inactive ingredients: alcohol (95% v/v), benzyl alcohol, edetate disodium, hydroxyethyl cellulose, polysorbate 20, propylene glycol, purified water and trolamine. Chemical Structure

💬 Information for Patients 45 words ▾

17 PATIENT COUNSELING INFORMATION Inform patients that naftifine hydrochloride gel is for topical use only. Naftifine hydrochloride gel is not intended for ophthalmic, oral, or intravaginal use. Patients should be directed to contact their physician if irritation develops with the use of naftifine hydrochloride gel.

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics In vitro and in vivo bioavailability studies have demonstrated that naftifine penetrates the stratum corneum in sufficient concentration to inhibit the growth of dermatophytes. Pharmacokinetic analysis of plasma samples from 32 subjects with tinea pedis treated with a mean dose of 3.9 grams naftifine hydrochloride gel applied once daily to both feet for 14 days showed increased exposure over the treatment period, with a geometric mean (CV%) AUC 0-24 (area under plasma concentration-versus-time curve from time 0 to 24 hours) of 10.5 (118) ng∙hr/mL on Day 1 and an AUC 0-24 of 70 (59) ng∙hr/mL on Day 14.

The accumulation ratio based on AUC was approximately 6. Maximum concentration (C max ) also increased over the treatment period; geometric mean (CV%) C max after a single dose was 0.9 (92) ng/mL on Day 1; C max on Day 14 was 3.7 (64) ng/mL. Median T max was 20 hours (range: 8, 20 hours) after a single application on Day 1 and 8 hours (range: 0, 24 hours) on Day 14.

Trough plasma concentrations increased during the trial period and reached steady state after 11 days. In the same pharmacokinetic trial, the fraction of dose excreted in urine during the treatment period was less than or equal to 0.01% of the applied dose. In a second trial, the pharmacokinetics of naftifine hydrochloride gel was evaluated in 22 pediatric subjects 12 to 17 years of age with tinea pedis.

Subjects were treated with a mean dose of 4.1 grams naftifine hydrochloride gel applied to the affected area once daily for 14 days. The results showed that the systemic exposure increased over the treatment period. Geometric mean (CV%) AUC 0-24 was 15.9 (212) ng∙hr/mL on Day 1 and 60 (131) ng∙hr/mL on Day 14.

Geometric mean (CV%) C max after a single dose was 1.40 (154) ng/mL on Day 1 and 3.81 (154) ng/mL on Day 14. The fraction of dose excreted in urine during the treatment period was less than or equal to 0.003% of the applied dose.

🧬 Pharmacodynamics 12 words ▾

12.2Pharmacodynamics The pharmacodynamics of naftifine hydrochloride gel have not been established.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES Naftifine hydrochloride gel has been evaluated for efficacy in two randomized, double-blind, vehicle-controlled, multicenter trials that included 1175 subjects with symptomatic and dermatophyte culture-positive interdigital tinea pedis. Subjects were randomized to receive naftifine hydrochloride gel or vehicle. Subjects applied naftifine hydrochloride gel 2% or vehicle to the affected area of the foot once daily for 2 weeks.

Signs and symptoms of interdigital tinea pedis (presence or absence of erythema, pruritus, and scaling) were assessed and potassium hydroxide (KOH) examination and dermatophyte culture were performed 6 weeks after the first treatment. The mean age of the study population was 45 years; 77% were male; and 60% were Caucasian, 35% were Black or African American, and 26% were Hispanic or Latino. At baseline, subjects were confirmed to have signs and symptoms of interdigital tinea pedis, positive KOH exam, and confirmed dermatophyte culture.

The primary efficacy endpoint was the proportion of subjects with a complete cure at 6 weeks after the start of treatment (4 weeks after the last treatment). Complete cure was defined as both a clinical cure (absence of erythema, pruritus, and scaling) and mycological cure (negative KOH and dermatophyte culture). The efficacy results at week 6, four weeks following the end of treatment, are presented in Table 1 below.

Table 1 Interdigital Tinea Pedis: Number (%) of Subjects With Complete Cure, Effective Treatment, and Mycological Cure at Week 6 Following Treatment With Naftifine Hydrochloride Gel (Full Analysis Set, Missing Values Treated as Treatment Failure) Trial 1 Trial 2 Endpoint Naftifine Hydrochloride Gel, 2% N=382 n (%) Vehicle N=179 n (%) Naftifine Hydrochloride Gel, 2% N=400 n (%) Vehicle N=213 n (%) Complete Cure Complete cure is a composite endpoint of both mycological cure and clinical cure. Clinical cure is defined as the absence of erythema, pruritus, and scaling (grade of 0).

64 (17%) 3 (2%) 104 (26%) 7 (3%) Treatment Effectiveness Effective treatment is a negative KOH preparation and negative dermatophyte culture, erythema, scaling, and pruritus grades of 0 or 1 (absent or nearly absent). 207 (54%) 11 (6%) 203 (51%) 15 (7%) Mycological Cure Mycological cure is defined as negative KOH and dermatophyte culture. 250 (65%) 25 (14%) 235 (59%) 22 (10%)

🧪 Nonclinical Toxicology 144 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 2-year dermal carcinogenicity study, naftifine hydrochloride cream was administered to Sprague- Dawley rats at topical doses of 1%, 2% and 3% (10 mg/kg/day, 20 mg/kg/day, and 30 mg/kg/day naftifine hydrochloride). No drug-related tumors were noted in this study up to the highest dose evaluated in this study of 30 mg/kg/day (36 times MRHD based on AUC comparison). Naftifine hydrochloride revealed no evidence of mutagenic or clastogenic potential based on the results of two in vitro genotoxicity tests (Ames assay and Chinese hamster ovary cell chromosome aberration assay) and one in vivo genotoxicity test (mouse bone marrow micronucleus assay).

Oral administration of naftifine hydrochloride to rats, throughout mating, gestation, parturition, and lactation, demonstrated no effects on growth, fertility, or reproduction, at doses up to 100 mg/kg/day (12 times MRHD based on mg/m 2 comparison).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 141 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 2-year dermal carcinogenicity study, naftifine hydrochloride cream was administered to Sprague- Dawley rats at topical doses of 1%, 2% and 3% (10 mg/kg/day, 20 mg/kg/day, and 30 mg/kg/day naftifine hydrochloride). No drug-related tumors were noted in this study up to the highest dose evaluated in this study of 30 mg/kg/day (36 times MRHD based on AUC comparison). Naftifine hydrochloride revealed no evidence of mutagenic or clastogenic potential based on the results of two in vitro genotoxicity tests (Ames assay and Chinese hamster ovary cell chromosome aberration assay) and one in vivo genotoxicity test (mouse bone marrow micronucleus assay).

Oral administration of naftifine hydrochloride to rats, throughout mating, gestation, parturition, and lactation, demonstrated no effects on growth, fertility, or reproduction, at doses up to 100 mg/kg/day (12 times MRHD based on mg/m 2 comparison).

📄 Package Label / Principal Display Panel 52 words ▾

PRINCIPAL DISPLAY PANEL - 60 g Tube Carton NDC 51672-1376-3 60 g Naftifine Hydrochloride Gel USP, 2% FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE, ORAL OR INTRAVAGINAL USE Rx only Keep this and all medications out of the reach of children. PRINCIPAL DISPLAY PANEL - 60 g Tube Carton carton label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
68
Units reimbursed last 4 qtrs
4.1K
Gross reimbursed last 4 qtrs
$29.3K
Avg / prescription
$430.67
Avg / unit
$7.1779
Latest quarter Q1 2026
34Rx
Medicaid pays / g
$7.1779
gross reimbursed
vs
NADAC / g
$8.5652
acquisition cost
=
Spread
−$1.3873
-16% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
100% FFS
Fee-for-service · 68 Rx Managed care · 0 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 960 units · 4.9 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 3,120 units · 8.0 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
4.98.0
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 California 8.0 /100k
2 New York 4.9 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 tube this page51672-1376-03 68 Rx · $29,286
1 tube51672-1376-06 67 Rx · $14,372
Drug total (last 4 qtrs): 135 Rx · 7,140 units · $43,658 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Naftifine Hydrochloride — the ingredient across all brands.

Top reported reactions

Pruritus33
Blister27
Skin Exfoliation26
Hypersensitivity25
Chronic Kidney Disease24
Rash23
Erythema21

Age at onset

Adolescent1
Adult20
Elderly17

Reporter sex

0 reports
Male · 50%
Female · 50%
Unknown · 0%

Serious outcomes

Hospitalization68
Death12
Disabling10
Life-threatening4
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 33 5
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
← 51672-1374-02 · Sun 51672-1377-06 · Sun →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.