Lamisil AT Cream — Cream

Overview

Brand name

Lamisil AT Cream

Generic name

Terbinafine Hydrochloride

Dosage form

Cream

Route

Topical

Marketing category

NDA · NDA

Labeler

Karo Healthcare Inc.

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

1

NDC product codes

4

Packages

4

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
Terbinafine Hydrochloride	1 g/100g	992528	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Cream

Route of administration

Topical

Presentations

8

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

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

020980

Application type

NDA · New Drug Application

Approval date

March 9, 1999

Sponsor

KARO HLTHCARE

Products on application

1

Submissions recorded

10

Products approved under application 020980.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
020980-001	LAMISIL	CREAM		TERBINAFINE 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 020980.
Type	No.	Action	Status	Date	Review
Supplement	12	Labeling	Approved	July 17, 2019	Standard
Supplement	11	Manufacturing (CMC)	Approved	November 24, 2014	Standard
Supplement	10	Manufacturing (CMC)	Approved	September 10, 2013	Standard
Supplement	9	Labeling	Approved	March 20, 2012	Standard
Supplement	7	Labeling	Approved	November 19, 2009	Standard
Supplement	5	Labeling	Approved	July 25, 2007	Standard
Supplement	3	Manufacturing (CMC)	Approved	May 9, 2001	Standard
Supplement	2	Manufacturing (CMC)	Approved	September 3, 1999	Standard
Supplement	1	Manufacturing (CMC)	Approved	July 22, 1999	Standard
Original application	1	Type 8 - Partial Rx to OTC Switch	Approved	March 9, 1999	Standard

Review documents

0 · Supplement · July 18, 2019
0 · Supplement · July 18, 2019
0 · Supplement · March 26, 2012
0 · Supplement · July 27, 2007
0 · Supplement · July 27, 2007
0 · Original application · June 8, 2004
0 · Original application · March 10, 1999

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251118). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20251118 HUMAN OTC DRUG · 20251002 HUMAN OTC DRUG · 20250109

Indications and Usage

openFDA Drug Labeling

Uses • cures most athlete's foot (tinea pedis) • cures most jock itch (tinea cruris) and ringworm (tinea corporis) • 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 over: o use the tip of the cap to break the seal and open the tube o wash the affected skin with soap and water and dry completely before applying o 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 o for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor o 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 eyes • for vaginal yeast infections When using this product do not get into eyes. If eye contact occurs, rinse thoroughly with water. Stop use and ask a doctor if too much irritation occurs or 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 eyes - for vaginal yeast infections

Stop Use

openFDA Drug Labeling

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

Active Ingredient

openFDA Drug Labeling

Active Ingredient Terbinafine hydrochloride 1% Purpose Antifungal

Adverse event reports

Source: openFDA FAERS

8,840

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: TERBINAFINE 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
84485-3607-1	84485-3607	Karo Healthcare Inc.	1 TUBE in 1 CARTON (84485-3607-1) / 12 g in 1 TUBE	January 20, 2025
84485-3748-3	84485-3748	Karo Healthcare Inc.	1 TUBE in 1 CARTON (84485-3748-3) / 30 g in 1 TUBE	November 1, 2024
84485-4030-1	84485-4030	Karo Healthcare Inc.	1 TUBE in 1 CARTON (84485-4030-1) / 12 g in 1 TUBE	October 9, 2025
61047-120-03	61047-120	Voyant Beauty Inc.	1 TUBE in 1 CARTON (61047-120-03) / 30 g in 1 TUBE	February 20, 2020
84485-3607	84485-3607	Karo Healthcare Inc.	—	January 20, 2025
84485-3748	84485-3748	Karo Healthcare Inc.	—	November 1, 2024
84485-4030	84485-4030	Karo Healthcare Inc.	—	October 9, 2025
61047-120	61047-120	Voyant Beauty Inc.	—	February 20, 2020

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.