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Athletes Foot Ultra

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 Ultra

Generic name

Butenafine Hydrochloride

Dosage form

Cream

Route

Topical

Marketing category

ANDA · ANDA

Labeler

Wal-Mart Stores Inc

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

NDC product codes

Packages

Data completeness

76% 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

Forms, strengths and routes

Source: NDC Directory

Dosage form

Cream

Route of administration

Topical

Presentations

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
Benzylamine Antifungal [EPC]	EPC	4 members — no class page
Benzylamines [CS]	CS	4 members — no class page

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

205181

Application type

ANDA · Abbreviated New Drug Application

Approval date

November 16, 2017

Sponsor

SUN PHARMA CANADA

Products on application

Submissions recorded

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 20250703). This is the manufacturer's labelling text, not a summary and not advice.

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

openFDA Drug Labeling

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 between the toes: apply to affected skin between and around the toes twice a day for 1 week (morning and night), or once a day for 4 weeks, or as directed by a doctor. Wear well-fitting, ventilated shoes. Change shoes and socks at least once daily. Apply between and around the toes 1 week twice a day or 4 weeks once a day for jock itch and ringworm: apply once a day to affected skin for 2 weeks or as directed by a doctor. wash hands after each use children under 12 years: ask a doctor Image

Warnings

openFDA Drug Labeling

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

openFDA Drug Labeling

Do not use on nails or scalp in or near the mouth or the eyes for vaginal yeast infections

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if too much irritation occurs or irritation gets worse

Active Ingredient

openFDA Drug Labeling

Active ingredient Butenafine hydrochloride 1%

Adverse event reports

Source: openFDA FAERS

586

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: BUTENAFINE HYDROCHLORIDE. 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
37808-013-02	37808-013	H E B	1 TUBE in 1 CARTON (37808-013-02) / 12 g in 1 TUBE	December 12, 2017
49035-225-08	49035-225	Wal-Mart Stores Inc	1 TUBE in 1 CARTON (49035-225-08) / 12 g in 1 TUBE	January 16, 2019
37808-013	37808-013	H E B	—	November 17, 2017
49035-225	49035-225	Wal-Mart Stores Inc	—	November 16, 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.