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Athletes Foot

Butenafine Hydrochloride · Cream

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Athletes Foot
Generic name
Butenafine Hydrochloride
Dosage form
Cream
Route
Topical
Marketing category
ANDA · ANDA
Labeler
Rite Aid Corporation
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
6
NDC product codes
14
Packages
21
Data completeness
82% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Butenafine Hydrochloride 10 mg/g 1298448 View
Clotrimazole 10 mg/g 308714 View
Miconazole Nitrate 2 g/100mL 992765 View
Terbinafine Hydrochloride 1 g/100g 992528 View
Tolnaftate .01 mg/10g 103951 —
Tolnaftate 10 mg/g 103951 —

Forms, strengths and routes

Source: NDC Directory
Dosage form
Cream
Route of administration
Topical
Presentations
35

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Allylamine Antifungal [EPC] EPC All 11 members
Allylamine [CS] CS All 11 members
Azole Antifungal [EPC] EPC All 44 members
Azoles [CS] CS All 44 members
Benzylamine Antifungal [EPC] EPC 4 members — no class page
Benzylamines [CS] CS 4 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
205181
Application type
ANDA · Abbreviated New Drug Application
Approval date
November 16, 2017
Sponsor
SUN PHARMA CANADA
Products on application
1
Submissions recorded
1
Products approved under application 205181.
Product Trade name Form Strength Ingredient Status TE Flags
205181-001 BUTENAFINE HYDROCHLORIDE CREAM BUTENAFINE HYDROCHLORIDE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 205181.
Type No. Action Status Date Review
Original application 1 Approved November 16, 2017 Standard

Review documents

  • 0 · Original application · July 22, 2020
  • 0 · Original application · December 18, 2017

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250925). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250925 HUMAN OTC DRUG · 20250728 HUMAN OTC DRUG · 20250715 HUMAN OTC DRUG · 20250703

Indications and Usage

openFDA Drug Labeling

Uses cures most athlete's foot between the toes. Effectiveness on the bottom or sides of foot is unknown. cures most jock itch and ringworm relieves itching, burning, cracking, and scaling which accompany these conditions

Purpose Antifungal

Dosage and Administration

openFDA Drug Labeling

Directions adults and children 12 years and older use the tip of the cap to break the seal and open the tube wash the affected skin with soap and water and dry completely before applying for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily. between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor. on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor. for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor. wash hands after each use children under 12 years: ask a doctor 1 week between the toes 2 weeks on the bottom or sides of the foot figure 1 figure 2

Warnings For external use only Do not use on nails or scalp in or near the mouth or the eyes for vaginal yeast infections When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water. Stop use and ask a doctor if too much irritation occurs or irritation gets worse Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do not use on children under 2 years of age unless directed by a doctor. For external use only. Avoid contact with eyes.

Stop use and ask a doctor if irritation occurs there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch).

Active Ingredient

openFDA Drug Labeling

Active ingredient Terbinafine hydrochloride 1%

Adverse event reports

Source: openFDA FAERS
12,736
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: CLOTRIMAZOLE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
69842-986-02 69842-986 CVS Pharmacy 1 TUBE in 1 CARTON (69842-986-02) / 30 g in 1 TUBE November 17, 2017
69842-986-03 69842-986 CVS Pharmacy 1 TUBE in 1 CARTON (69842-986-03) / 30 g in 1 TUBE November 21, 2019
69842-986-08 69842-986 CVS Pharmacy 1 TUBE in 1 CARTON (69842-986-08) / 12 g in 1 TUBE November 17, 2017
55910-341-24 55910-341 Dollar General 1 TUBE in 1 CARTON (55910-341-24) / 28 g in 1 TUBE October 1, 2017
55315-008-56 55315-008 FRED'S, INC. 1 TUBE in 1 CARTON (55315-008-56) / 28.4 g in 1 TUBE November 15, 2018
37808-080-01 37808-080 H E B 1 TUBE in 1 CARTON (37808-080-01) / 15 g in 1 TUBE July 2, 2007
56062-080-02 56062-080 Publix Super Markets Inc. 1 TUBE in 1 CARTON (56062-080-02) / 30 g in 1 TUBE February 4, 2009
70084-510-01 70084-510 Quantum, Inc. 1 TUBE in 1 CARTON (70084-510-01) / 21 g in 1 TUBE December 5, 2005
83004-014-01 83004-014 Rida LLC 1 BOTTLE in 1 CARTON (83004-014-01) / 120 mL in 1 BOTTLE February 27, 2025
11822-0080-1 11822-0080 Rite Aid Corporation 1 TUBE in 1 CARTON (11822-0080-1) / 15 g in 1 TUBE October 28, 2019
11822-0080-2 11822-0080 Rite Aid Corporation 1 TUBE in 1 CARTON (11822-0080-2) / 30 g in 1 TUBE October 28, 2019
11822-2100-2 11822-2100 Rite Aid Corporation 1 TUBE in 1 CARTON (11822-2100-2) / 30 g in 1 TUBE November 17, 2017
11822-2100-8 11822-2100 Rite Aid Corporation 1 TUBE in 1 CARTON (11822-2100-8) / 12 g in 1 TUBE November 17, 2017
70677-1269-1 70677-1269 STRATEGIC SOURCING SERVICES LLC 1 TUBE in 1 CARTON (70677-1269-1) / 30 g in 1 TUBE November 7, 2024
51672-2100-1 51672-2100 Sun Pharmaceutical Industries, Inc. 1 TUBE in 1 CARTON (51672-2100-1) / 15 g in 1 TUBE November 17, 2017
51672-2100-2 51672-2100 Sun Pharmaceutical Industries, Inc. 1 TUBE in 1 CARTON (51672-2100-2) / 30 g in 1 TUBE November 17, 2017
51672-2100-8 51672-2100 Sun Pharmaceutical Industries, Inc. 1 TUBE in 1 CARTON (51672-2100-8) / 12 g in 1 TUBE November 17, 2017
51672-2100-9 51672-2100 Sun Pharmaceutical Industries, Inc. 1 TUBE in 1 CARTON (51672-2100-9) / 24 g in 1 TUBE November 17, 2017
36800-049-01 36800-049 TOPCO ASSOCIATES LLC 1 TUBE in 1 CARTON (36800-049-01) / 12 g in 1 TUBE December 12, 2017
11673-016-02 11673-016 Target Corporation 1 TUBE in 1 CARTON (11673-016-02) / 30 g in 1 TUBE November 30, 2017
0363-2100-02 0363-2100 Walgreen Company 1 TUBE in 1 CARTON (0363-2100-02) / 30 g in 1 TUBE November 17, 2017
69842-986 69842-986 CVS Pharmacy — November 17, 2017
55910-341 55910-341 Dollar General — October 1, 2017
55315-008 55315-008 FRED'S, INC. — November 15, 2018
37808-080 37808-080 H E B — July 2, 2007
56062-080 56062-080 Publix Super Markets Inc. — July 2, 2007
70084-510 70084-510 Quantum, Inc. — December 5, 2005
83004-014 83004-014 Rida LLC — February 27, 2025
11822-0080 11822-0080 Rite Aid Corporation — July 2, 2007
11822-2100 11822-2100 Rite Aid Corporation — November 17, 2017
70677-1269 70677-1269 STRATEGIC SOURCING SERVICES LLC — November 7, 2024
51672-2100 51672-2100 Sun Pharmaceutical Industries, Inc. — November 17, 2017
36800-049 36800-049 TOPCO ASSOCIATES LLC — November 17, 2017
11673-016 11673-016 Target Corporation — November 17, 2017
0363-2100 0363-2100 Walgreen Company — November 17, 2017

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.