Lamisil AT Cream

Product NDC: 84485-3607
11-digit product format: 844853607
Labeler code: 84485
Product ID: 84485-3607_dc1dfa6d-7d6d-43cf-a25a-8497e3430bcd
Type: HUMAN OTC DRUG
Nonproprietary name: Terbinafine Hydrochloride
Dosage form: CREAM
Route: TOPICAL
Labeler: Karo Healthcare Inc.
Application: NDA020980
Marketing category: NDA
Marketing start: 2025-01-20
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 Cream
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
0f59271d-997f-4dcc-aae3-900b53df1c95	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	Strength	SPL version
84485-3607-1	Lamisil AT Cream	1 in 1 CARTON	CREAM	1		1
84485-3607-1	Lamisil AT Cream	12 g in 1 TUBE	CREAM	12		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
84485-3607	LAMISIL AT CREAM (TERBINAFINE HYDROCHLORIDE) CREAM [KARO HEALTHCARE INC.]	1	Current NDC, 2 package rows	20250120_0f59271d-997f-4dcc-aae3-900b53df1c95.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 ndc (product): 84485-3607

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	0f59271d-997f-4dcc-aae3-900b53df1c95	1
992528	terbinafine HCl 1 % Topical Cream	PSN	0f59271d-997f-4dcc-aae3-900b53df1c95	1
992530	terbinafine hydrochloride 10 MG/ML Topical Cream [Lamisil]	SBD	0f59271d-997f-4dcc-aae3-900b53df1c95	1
992528	terbinafine hydrochloride 10 MG/ML Topical Cream	SCD	0f59271d-997f-4dcc-aae3-900b53df1c95	1
992530	Lamisil 10 MG/ML Topical Cream	SY	0f59271d-997f-4dcc-aae3-900b53df1c95	1
992530	Lamisil AT 1 % Topical Cream	SY	0f59271d-997f-4dcc-aae3-900b53df1c95	1
992528	terbinafine hydrochloride 1 % Topical Cream	SY	0f59271d-997f-4dcc-aae3-900b53df1c95	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84485-3607-1	84485360701	1 TUBE in 1 CARTON (84485-3607-1) / 12 g in 1 TUBE	1 tube	2025-01-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lamisil AT (Terbinafine Hydrochloride) Cream 1% 12g	Karo Healthcare Inc.	2025-01-09	HUMAN OTC DRUG LABEL	1