Application 020524

Type: NDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MENTAX	BUTENAFINE HYDROCHLORIDE	CREAM;TOPICAL	1%	Yes	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
N020524-001	MENTAX	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL		RLD	1996-10-18

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	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD	1996-10-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD	1996-10-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD	1996-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD	1996-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD	1996-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD	1996-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD	1996-10-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD	1996-10-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD	1996-10-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD	1996-10-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD	1996-10-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD	1996-10-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD	1996-10-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD	1996-10-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD	1996-10-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD, RS	1996-10-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD, RS	1996-10-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD, RS	1996-10-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD, RS	1996-10-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD, RS	1996-10-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD, RS	1996-10-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD, RS	1996-10-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD, RS	1996-10-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD, RS	1996-10-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD, RS	1996-10-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD, RS	1996-10-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD, RS	1996-10-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD, RS	1996-10-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD	1996-10-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD	1996-10-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD	1996-10-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD	1996-10-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD	1996-10-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD, RS	1996-10-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD, RS	1996-10-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD, RS	1996-10-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD, RS	1996-10-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD, RS	1996-10-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD, RS	1996-10-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020524-001	MENTAX	1%	CREAM / TOPICAL	RLD, RS	1996-10-18	`e64feba35796…`

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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Butenafine Hydrochloride	BUTENAFINE HYDROCHLORIDE	YYBA CORP	e650d8aa-c809-42ee-a1d9-a6321d5364f5	2025-12-10	Warnings	Name fallback generic name: BUTENAFINE HYDROCHLORIDE
Lotrimin Ultra Jock Itch	BUTENAFINE HYDROCHLORIDE	Bayer Healthcare LLC.	9dfa08fb-0913-4326-b1eb-1425df6a2c82	2025-12-05	Warnings	Name fallback generic name: BUTENAFINE HYDROCHLORIDE
Lotrimin Ultra Athletes Foot	BUTENAFINE HYDROCHLORIDE	Bayer Healthcare LLC.	e258c4ac-53ef-4a99-b732-4985f890b938	2025-12-05	Warnings	Name fallback generic name: BUTENAFINE HYDROCHLORIDE
Lotrimin Ultra	BUTENAFINE HYDROCHLORIDE	Bayer Healthcare LLC.	d11dfdf6-9b36-03bc-e053-2995a90a0bc3	2025-12-04	Warnings	Name fallback generic name: BUTENAFINE HYDROCHLORIDE
Lotrimin Ultra Ringworm	BUTENAFINE HYDROCHLORIDE	Bayer Healthcare LLC.	1b438ca7-fd5f-62cb-e063-6294a90ab3a6	2025-12-04	Warnings	Name fallback generic name: BUTENAFINE HYDROCHLORIDE
Athletes Foot	BUTENAFINE HYDROCHLORIDE	CVS Pharmacy	5ef3c059-fc25-42da-89c7-b5dab9991795	2025-07-03	Warnings	Name fallback generic name: BUTENAFINE HYDROCHLORIDE
Athletes Foot	BUTENAFINE HYDROCHLORIDE	Rite Aid Corporation	103ff59d-7276-4bd9-8633-c992ff311d0e	2025-07-03	Warnings	Name fallback generic name: BUTENAFINE HYDROCHLORIDE
Athletes Foot	BUTENAFINE HYDROCHLORIDE	STRATEGIC SOURCING SERVICES LLC	b4913a89-56fd-4710-b28e-6fb6d50fd3f3	2025-07-03	Warnings	Name fallback generic name: BUTENAFINE HYDROCHLORIDE
Athletes Foot	BUTENAFINE HYDROCHLORIDE	Target Corporation	59494e7f-fd70-4a60-bb1d-4a5ffee945c1	2025-07-03	Warnings	Name fallback generic name: BUTENAFINE HYDROCHLORIDE
Athletes Foot	BUTENAFINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	3e976ed8-2af8-4d1e-bda6-e2f672c7ec03	2025-07-03	Warnings	Name fallback generic name: BUTENAFINE HYDROCHLORIDE
Athletes Foot	BUTENAFINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	4b400be5-acaa-4a5f-b8ef-c0df8ad6175f	2025-07-03	Warnings	Name fallback generic name: BUTENAFINE HYDROCHLORIDE
Athletes Foot	BUTENAFINE HYDROCHLORIDE	Walgreen Company	4ce8cba1-d637-42c0-8b8b-79bb117b2cd1	2025-07-03	Warnings	Name fallback generic name: BUTENAFINE HYDROCHLORIDE
Athletes Foot Ultra	BUTENAFINE HYDROCHLORIDE	H E B	0841f741-6409-4d93-a6a7-901808f77bcd	2025-07-03	Warnings	Name fallback generic name: BUTENAFINE HYDROCHLORIDE
Athletes Foot Ultra	BUTENAFINE HYDROCHLORIDE	Wal-Mart Stores Inc	a77a2694-04e7-4b37-ac6a-34f896945912	2025-07-03	Warnings	Name fallback generic name: BUTENAFINE HYDROCHLORIDE
Butenafine Hydrochloride	BUTENAFINE HYDROCHLORIDE	MEIJER DISTRIBUTION INC	4e88068b-1449-43b4-9c7c-4ad8e877459b	2025-07-03	Warnings	Name fallback generic name: BUTENAFINE HYDROCHLORIDE
Butenafine Hydrochloride 1%	BUTENAFINE HYDROCHLORIDE	CVS Pharmacy	83830b24-bc94-4764-a6ca-3193abd9de66	2025-07-03	Warnings	Name fallback generic name: BUTENAFINE HYDROCHLORIDE
Butenafine Hydrochloride Athletes Foot	BUTENAFINE HYDROCHLORIDE	Kroger Company	2af91428-3fb9-4974-a55f-87aad750d05b	2025-07-03	Warnings	Name fallback generic name: BUTENAFINE HYDROCHLORIDE
Butenafine Hydrochloride	BUTENAFINE HYDROCHLORIDE	Albertsons	098dee89-0f7b-4341-a691-bfe6077ff353	2025-07-03	Warnings	Name fallback generic name: BUTENAFINE HYDROCHLORIDE
Butenafine Hydrochloride Jock Itch	BUTENAFINE HYDROCHLORIDE	Wal-Mart Stores Inc	be9a411c-55d7-4db5-a420-30013efbbc24	2025-07-03	Warnings	Name fallback generic name: BUTENAFINE HYDROCHLORIDE
Jock Itch	BUTENAFINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	14a23a39-b567-4db4-bac0-c008c0ca6171	2025-07-03	Warnings	Name fallback generic name: BUTENAFINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-6151	MENTAX	butenafine hydrochloride	Mylan Pharmaceuticals Inc.	NDA	Current
0378-6151	MENTAX	butenafine hydrochloride	Mylan Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57657	ORIG	2019-02-15
20702	SUPPL	2001-11-20
34769	SUPPL	2001-06-06
2663	SUPPL	2001-06-06