Lamisil AT — Spray

Overview

Brand name

Lamisil AT

Generic name

terbinafine hydrochloride

Dosage form

Spray

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

2

Packages

2

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

Spray

Route of administration

Topical

Presentations

4

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

021124

Application type

NDA · New Drug Application

Approval date

March 17, 2000

Sponsor

KARO HLTHCARE

Products on application

2

Submissions recorded

12

Products approved under application 021124.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
021124-001	LAMISIL AT	SOLUTION		TERBINAFINE HYDROCHLORIDE	Over-the-counter	—	RLD RS
021124-002	LAMISIL AT	SPRAY		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 021124.
Type	No.	Action	Status	Date	Review
Supplement	15	Manufacturing (CMC)	Approved	July 18, 2019	N/A
Supplement	16	Labeling	Approved	October 18, 2018	Standard
Supplement	13	Labeling	Approved	November 13, 2013	Standard
Supplement	11	Labeling	Approved	March 20, 2012	Standard
Supplement	9	Labeling	Approved	February 12, 2010	Standard
Supplement	8	Manufacturing (CMC)	Approved	June 15, 2009	N/A
Supplement	7	Manufacturing (CMC)	Approved	July 25, 2008	N/A
Supplement	4	Manufacturing (CMC)	Approved	July 25, 2002	Standard
Supplement	3	Manufacturing (CMC)	Approved	April 8, 2002	Standard
Supplement	2	Manufacturing (CMC)	Approved	March 11, 2002	Standard
Supplement	1	Manufacturing (CMC)	Approved	May 9, 2001	Standard
Original application	1	Type 8 - Partial Rx to OTC Switch	Approved	March 17, 2000	Standard

Review documents

0 · Supplement · October 26, 2018
0 · Supplement · October 23, 2018
0 · Supplement · November 19, 2013
0 · Supplement · November 15, 2013
0 · Supplement · March 26, 2012
0 · Supplement · February 22, 2010
0 · Supplement · June 17, 2009
0 · Supplement · July 31, 2008
0 · Original application · May 15, 2002
0 · Original application · March 17, 2000
0 · Original application · March 17, 2000

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251212). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20251212

Indications and Usage

openFDA Drug Labeling

Uses • cures most athlete’s foot (tinea pedis) between the toes. Effectiveness on the bottom or sides of foot is unknown. • 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: • wash the affected area with soap and water and dry completely before applying • to open remove clear cap • hold can 4" to 6" from skin. Press and hold to spray a thin layer over affected area • release to stop spray • wipe excess from spray opening after each use • return cap to can • for athlete’s foot between the toes spray twice a day (morning and night) for 1 week or as directed by a doctor. Wear well-fitting, ventilated shoes. Change shoes and socks at least once daily. • for jock itch and ringworm spray affected area 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

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. • do not puncture or incinerate; contents under pressure. Do not expose to heat or store at temperatures above 120°F (49°C). 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
84485-3605-4	84485-3605	Karo Healthcare Inc.	120 g in 1 CAN (84485-3605-4)	December 10, 2025
84485-3606-4	84485-3606	Karo Healthcare Inc.	120 g in 1 CAN (84485-3606-4)	December 10, 2025
84485-3605	84485-3605	Karo Healthcare Inc.	—	December 10, 2025
84485-3606	84485-3606	Karo Healthcare Inc.	—	December 10, 2025

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.