Lamisil

Product NDC: 0067-3998
11-digit product format: 000673998
Labeler code: 0067
Product ID: 0067-3998_f4438d90-0dcc-40ee-92a7-bdceb17ef010
Type: HUMAN OTC DRUG
Nonproprietary name: TERBINAFINE HYDROCHLORIDE
Dosage form: CREAM
Route: TOPICAL
Labeler: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Application: NDA020980
Marketing category: NDA
Marketing start: 2005-08-10
Marketing end: 0000-00-00
Substance: TERBINAFINE HYDROCHLORIDE
Active strength: 10 mg/g
Pharmacologic classes: Allylamine Antifungal [EPC], Allylamine [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0067-3998		D	Discontinued by firm	2026-08-17
excluded package	package	0067-3998	0067-3998-30	D	Discontinued by firm	2026-08-17
excluded package	package	0067-3998	0067-3998-42	D	Discontinued by firm	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	0067-3998		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0067-3998	0067-3998-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0067-3998	0067-3998-42	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0067-3998-30	GM - Gram	0067-3998	c5194c04-ec09-42d0-9e6a-2841df61b2d8	1	2012-07-24
0067-3998-42	GM - Gram	0067-3998	9a7ec9f9-45b7-44f0-9469-3d8b4bd69d2f	1	2012-07-24
0067-3998-99	GM - Gram	0067-3998	405e8a31-012d-421c-a920-3bfce3bd8a82	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TERBINAFINE HYDROCHLORIDE	ACTIVE INGREDIENT	012C11ZU6G	LAMISIL AT (TERBINAFINE HYDROCHLORIDE) CREAM [NOVARTIS CONSUMER HEALTH, INC.]	3
TERBINAFINE	ACTIVE MOIETY	G7RIW8S0XP	LAMISIL AT (TERBINAFINE HYDROCHLORIDE) CREAM [NOVARTIS CONSUMER HEALTH, INC.]	3
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	LAMISIL AT (TERBINAFINE HYDROCHLORIDE) CREAM [NOVARTIS CONSUMER HEALTH, INC.]	3
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	LAMISIL AT (TERBINAFINE HYDROCHLORIDE) CREAM [NOVARTIS CONSUMER HEALTH, INC.]	3
CETYL PALMITATE	INACTIVE INGREDIENT	5ZA2S6B08X	LAMISIL AT (TERBINAFINE HYDROCHLORIDE) CREAM [NOVARTIS CONSUMER HEALTH, INC.]	3
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	LAMISIL AT (TERBINAFINE HYDROCHLORIDE) CREAM [NOVARTIS CONSUMER HEALTH, INC.]	3
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	LAMISIL AT (TERBINAFINE HYDROCHLORIDE) CREAM [NOVARTIS CONSUMER HEALTH, INC.]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	LAMISIL AT (TERBINAFINE HYDROCHLORIDE) CREAM [NOVARTIS CONSUMER HEALTH, INC.]	3
SORBITAN MONOSTEARATE	INACTIVE INGREDIENT	NVZ4I0H58X	LAMISIL AT (TERBINAFINE HYDROCHLORIDE) CREAM [NOVARTIS CONSUMER HEALTH, INC.]	3
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	LAMISIL AT (TERBINAFINE HYDROCHLORIDE) CREAM [NOVARTIS CONSUMER HEALTH, INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	LAMISIL AT (TERBINAFINE HYDROCHLORIDE) CREAM [NOVARTIS CONSUMER HEALTH, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0067-3998	LAMISIL AT (TERBINAFINE HYDROCHLORIDE) CREAM [HALEON US HOLDINGS LLC]	8	Legacy NDC	20240327_de5def4a-f77f-4ea6-a497-24f041c1f123.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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0067-3998-30	00067399830	1 TUBE in 1 CARTON (0067-3998-30) > 30 g in 1 TUBE	1 tube	2005-08-10	0000-00-00	No	No	Current
0067-3998-42	00067399842	1 TUBE in 1 CARTON (0067-3998-42) > 12 g in 1 TUBE	1 tube	2005-08-10	0000-00-00	No	No	Current