Lamisil AT

Product NDC: 84485-3606
Requested package NDC: 84485-3606-4
11-digit product format: 844853606
Labeler code: 84485
Product ID: 84485-3606_d3e75665-e2d4-47d9-baaa-93817b5fbf00
Type: HUMAN OTC DRUG
Nonproprietary name: terbinafine hydrochloride
Dosage form: SPRAY
Route: TOPICAL
Labeler: Karo Healthcare Inc.
Application: NDA021124
Marketing category: NDA
Marketing start: 2025-12-10
Substance: TERBINAFINE HYDROCHLORIDE
Active strength: 1 g/100g
Pharmacologic classes: Allylamine Antifungal [EPC], Allylamine [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021124-001	LAMISIL AT	TERBINAFINE HYDROCHLORIDE	1%	SOLUTION / TOPICAL		RLD, RS	2000-03-17
N021124-002	LAMISIL AT	TERBINAFINE HYDROCHLORIDE	1%	SPRAY / TOPICAL		RLD, RS	2000-03-17

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Lamisil AT
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TERBINAFINE HYDROCHLORIDE	1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
012C11ZU6G	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
992535	Internal RxNorm lookup
992536	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d3e75665-e2d4-47d9-baaa-93817b5fbf00	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
55a24767-1759-5f6a-8888-ea4aa0adac21	Product name	1	20140508
db9701af-cb4f-b8ba-d282-6bc5b6b7c467	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
84485-3606-4	Lamisil AT	120 g in 1 CAN	SPRAY	120		1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lamisil AT	TERBINAFINE HYDROCHLORIDE	Karo Healthcare Inc.	21f1bf77-4338-4b75-b513-80a0d98a722a	2025-12-12	Warnings	Exact identifier application applno (NDA): 021124 application number: NDA021124
Lamisil AT	TERBINAFINE HYDROCHLORIDE	Karo Healthcare Inc.	d3e75665-e2d4-47d9-baaa-93817b5fbf00	2025-12-12	Warnings	Exact identifier application applno (NDA): 021124 application number: NDA021124 ndc (package): 84485-3606-4 ndc (product): 84485-3606 ndc11 (package): 84485360604

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
012C11ZU6G	TERBINAFINE HYDROCHLORIDE	78628-80-5	TERBINAFINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
992536	LamISIL AT 1 % Topical Spray	PSN	d3e75665-e2d4-47d9-baaa-93817b5fbf00	1
992535	terbinafine HCl 1 % Topical Spray	PSN	d3e75665-e2d4-47d9-baaa-93817b5fbf00	1
992536	terbinafine hydrochloride 10 MG/ML Topical Spray [Lamisil]	SBD	d3e75665-e2d4-47d9-baaa-93817b5fbf00	1
992535	terbinafine hydrochloride 10 MG/ML Topical Spray	SCD	d3e75665-e2d4-47d9-baaa-93817b5fbf00	1
992536	Lamisil 1 % Topical Spray	SY	d3e75665-e2d4-47d9-baaa-93817b5fbf00	1
992536	Lamisil 10 MG/ML Topical Spray	SY	d3e75665-e2d4-47d9-baaa-93817b5fbf00	1
992536	Lamisil AT 1 % Topical Spray	SY	d3e75665-e2d4-47d9-baaa-93817b5fbf00	1
992535	terbinafine hydrochloride 1 % Topical Spray	SY	d3e75665-e2d4-47d9-baaa-93817b5fbf00	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84485-3606-4	84485360604	120 g in 1 CAN (84485-3606-4)	120 g	2025-12-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lamisil AT (Terbinafine Hydrochloride) Spray 1% 120 g	Karo Healthcare Inc.	2025-12-12	HUMAN OTC DRUG LABEL	1