LAMISIL AT TERBINAFINE HYDROCHLORIDE

Product NDC: 61047-139
11-digit product format: 610470139
Labeler code: 61047
Product ID: 61047-139_3f018131-adda-6d1b-e063-6394a90a09f5
Type: HUMAN OTC DRUG
Nonproprietary name: Terbinafine hydrochloride
Dosage form: CREAM
Route: TOPICAL
Labeler: Voyant Beauty, Inc.
Application: NDA020980
Marketing category: NDA
Marketing start: 2024-08-21
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 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020980-001	LAMISIL	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL		RLD, RS	1999-03-09

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020980-001	LAMISIL	1%	CREAM / TOPICAL	RLD, RS	1999-03-09	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: LAMISIL AT TERBINAFINE HYDROCHLORIDE
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
992528	Internal RxNorm lookup
992530	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
1fd313ad-a3d9-6c86-e063-6394a90a7ae4	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
9869efd7-d6dd-0665-5b67-53adbe6ef15e	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	SPL version
61047-139-01	LAMISIL AT TERBINAFINE HYDROCHLORIDE	30 g in 1 TUBE	CREAM	30	3
61047-139-01	LAMISIL AT TERBINAFINE HYDROCHLORIDE	1 in 1 CARTON	CREAM	1	3
61047-139-02	LAMISIL AT TERBINAFINE HYDROCHLORIDE	12 g in 1 TUBE	CREAM	12	3
61047-139-02	LAMISIL AT TERBINAFINE HYDROCHLORIDE	1 in 1 CARTON	CREAM	1	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61047-139	LAMISIL AT TERBINAFINE HYDROCHLORIDE (TERBINAFINE HYDROCHLORIDE) CREAM [VOYANT BEAUTY, INC.]	2	Current NDC, 4 package rows	20250104_1fd313ad-a3d9-6c86-e063-6394a90a7ae4.zip

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lamisil AT Cream	TERBINAFINE HYDROCHLORIDE	Voyant Beauty Inc.	9dea4789-bf1c-1577-e053-2a95a90a5381	2025-11-18	Warnings	Exact identifier application applno (NDA): 020980 application number: NDA020980
Lamisil AT Cream	TERBINAFINE HYDROCHLORIDE	Karo Healthcare Inc.	1aa5e03a-432b-4154-ab6e-6dbce7a67109	2025-10-02	Warnings	Exact identifier application applno (NDA): 020980 application number: NDA020980
LAMISIL AT TERBINAFINE HYDROCHLORIDE	TERBINAFINE HYDROCHLORIDE	Voyant Beauty, Inc.	1fd313ad-a3d9-6c86-e063-6394a90a7ae4	2025-09-17	Warnings	Exact identifier application applno (NDA): 020980 application number: NDA020980 ndc (product): 61047-139
Lamisil AT Cream	TERBINAFINE HYDROCHLORIDE	Karo Healthcare Inc.	7f8434c2-60c9-4aeb-b0b8-f69107e74609	2025-01-09	Warnings	Exact identifier application applno (NDA): 020980 application number: NDA020980
Lamisil AT Cream	TERBINAFINE HYDROCHLORIDE	Karo Healthcare Inc.	0f59271d-997f-4dcc-aae3-900b53df1c95	2025-01-09	Warnings	Exact identifier application applno (NDA): 020980 application number: NDA020980

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
992530	LamISIL AT 1 % Topical Cream	PSN	1fd313ad-a3d9-6c86-e063-6394a90a7ae4	3
992528	terbinafine HCl 1 % Topical Cream	PSN	1fd313ad-a3d9-6c86-e063-6394a90a7ae4	3
992530	terbinafine hydrochloride 10 MG/ML Topical Cream [Lamisil]	SBD	1fd313ad-a3d9-6c86-e063-6394a90a7ae4	3
992528	terbinafine hydrochloride 10 MG/ML Topical Cream	SCD	1fd313ad-a3d9-6c86-e063-6394a90a7ae4	3
992530	Lamisil 10 MG/ML Topical Cream	SY	1fd313ad-a3d9-6c86-e063-6394a90a7ae4	3
992530	Lamisil AT 1 % Topical Cream	SY	1fd313ad-a3d9-6c86-e063-6394a90a7ae4	3
992528	terbinafine hydrochloride 1 % Topical Cream	SY	1fd313ad-a3d9-6c86-e063-6394a90a7ae4	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
61047-139-01	61047013901	1 TUBE in 1 CARTON (61047-139-01) / 30 g in 1 TUBE	1 tube	2024-08-21	No	No	Current
61047-139-02	61047013902	1 TUBE in 1 CARTON (61047-139-02) / 12 g in 1 TUBE	1 tube	2025-01-06	No	No	Current