Lotrimin Ultra — Cream

Overview

Brand name

Lotrimin Ultra Jock Itch

Generic name

Butenafine hydrochloride

Dosage form

Cream

Route

Topical

Marketing category

NDA · NDA

Labeler

Bayer Healthcare LLC.

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

1

NDC product codes

4

Packages

8

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	1 g/100g	1298448	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Cream

Route of administration

Topical

Presentations

12

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

021307

Application type

NDA · New Drug Application

Approval date

December 7, 2001

Sponsor

BAYER HEALTHCARE LLC

Products on application

1

Submissions recorded

13

Products approved under application 021307.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
021307-001	LOTRIMIN ULTRA	CREAM		BUTENAFINE HYDROCHLORIDE	Over-the-counter	—	RLD RS

Therapeutic equivalence

Source: Orange Book

TE code

—

Reference Listed Drug

Yes

Reference Standard

Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA

Most recent submissions on application 021307.
Type	No.	Action	Status	Date	Review
Supplement	24	Labeling	Approved	July 10, 2024	Standard
Supplement	23	Labeling	Approved	April 19, 2024	Standard
Supplement	22	Labeling	Approved	January 2, 2024	Standard
Supplement	21	Labeling	Approved	August 29, 2023	Standard
Supplement	19	Labeling	Approved	October 18, 2021	Standard
Supplement	18	Manufacturing (CMC)	Approved	December 15, 2020	N/A
Supplement	16	Manufacturing (CMC)	Approved	January 19, 2017	Standard
Supplement	15	Labeling	Approved	December 18, 2015	Standard
Supplement	14	Efficacy	Approved	December 17, 2014	Standard
Supplement	13	Labeling	Approved	May 2, 2012	Standard
Supplement	12	Labeling	Approved	March 31, 2011	Standard
Supplement	4	Labeling	Approved	April 3, 2006	Standard
Original application	1	Type 8 - Partial Rx to OTC Switch	Approved	December 7, 2001	Standard

Review documents

0 · Supplement · July 11, 2024
0 · Supplement · July 11, 2024
0 · Supplement · April 22, 2024
0 · Supplement · April 22, 2024
0 · Supplement · January 4, 2024
0 · Supplement · January 4, 2024
0 · Supplement · August 31, 2023
0 · Supplement · August 30, 2023
0 · Supplement · December 13, 2021
0 · Supplement · October 20, 2021
0 · Supplement · December 23, 2020
0 · Supplement · December 23, 2020
0 · Supplement · December 22, 2015
0 · Supplement · December 22, 2015
0 · Supplement · December 18, 2014
0 · Supplement · May 4, 2012
0 · Supplement · April 4, 2011
0 · Supplement · April 7, 2006
0 · Original application · March 26, 2002
0 · Original application · December 7, 2001
0 · Original application · December 7, 2001

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251205). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20251205 HUMAN OTC DRUG · 20251204 HUMAN OTC DRUG · 20251204

Indications and Usage

openFDA Drug Labeling

Uses cures most ringworm cures most jock itch cures most athlete's foot between the toes. Effectiveness on the bottom or sides of foot is unknown. 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: wash the affected skin with soap and water and dry completely before applying to open the applicator, twist the base to the ON position. Squeeze tube to dispense cream. 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. wipe applicator tip with a tissue and close the applicator by twisting the base to the OFF position wash hands after each use children under 12 years: ask a doctor

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
11523-0082-1	11523-0082	Bayer Healthcare LLC.	1 TUBE, WITH APPLICATOR in 1 CARTON (11523-0082-1) / 20 g in 1 TUBE, WITH APPLICATOR	December 20, 2021
11523-0158-2	11523-0158	Bayer Healthcare LLC.	1 TUBE in 1 CARTON (11523-0158-2) / 30 g in 1 TUBE	July 31, 2024
11523-4338-1	11523-4338	Bayer Healthcare LLC.	1 TUBE in 1 CARTON (11523-4338-1) / 12 g in 1 TUBE	February 22, 2002
11523-4338-2	11523-4338	Bayer Healthcare LLC.	1 TUBE in 1 CARTON (11523-4338-2) / 15 g in 1 TUBE	February 22, 2002
11523-4338-4	11523-4338	Bayer Healthcare LLC.	1 TUBE in 1 CARTON (11523-4338-4) / 30 g in 1 TUBE	February 22, 2002
11523-4339-1	11523-4339	Bayer Healthcare LLC.	1 TUBE in 1 CARTON (11523-4339-1) / 12 g in 1 TUBE	February 22, 2002
11523-4339-2	11523-4339	Bayer Healthcare LLC.	1 TUBE in 1 CARTON (11523-4339-2) / 15 g in 1 TUBE	February 22, 2002
11523-4339-3	11523-4339	Bayer Healthcare LLC.	1 TUBE in 1 CARTON (11523-4339-3) / 30 g in 1 TUBE	September 26, 2023
11523-0082	11523-0082	Bayer Healthcare LLC.	—	December 20, 2021
11523-0158	11523-0158	Bayer Healthcare LLC.	—	January 2, 2024
11523-4338	11523-4338	Bayer Healthcare LLC.	—	February 22, 2002
11523-4339	11523-4339	Bayer Healthcare LLC.	—	February 22, 2002

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 · 11 sections on this page.