Butenafine Hydrochloride

Product NDC: 73581-210
11-digit product format: 735810210
Labeler code: 73581
Product ID: 73581-210_459b7a6e-8c81-2084-e063-6294a90a4083
Type: HUMAN OTC DRUG
Nonproprietary name: Butenafine Hydrochloride
Dosage form: CREAM
Route: TOPICAL
Labeler: YYBA CORP
Application: ANDA205181
Marketing category: ANDA
Marketing start: 2023-10-12
Substance: BUTENAFINE HYDROCHLORIDE
Active strength: 10 mg/g
Pharmacologic classes: Benzylamine Antifungal [EPC], Benzylamines [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 1.

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
A205181-001	BUTENAFINE HYDROCHLORIDE	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL			2017-11-16

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2024-11-08 22:44 UTC · 2 captures of this ZIP	2024-11	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`cb3db0bc1861…`
2026-08-01 22:54:32	2026-06	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 18 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	Exact identifier application applno (ANDA): 205181 application number: ANDA205181 ndc (product): 73581-210
Athletes Foot	BUTENAFINE HYDROCHLORIDE	CVS Pharmacy	5ef3c059-fc25-42da-89c7-b5dab9991795	2025-07-03	Warnings	Exact identifier application applno (ANDA): 205181 application number: ANDA205181
Athletes Foot	BUTENAFINE HYDROCHLORIDE	Rite Aid Corporation	103ff59d-7276-4bd9-8633-c992ff311d0e	2025-07-03	Warnings	Exact identifier application applno (ANDA): 205181 application number: ANDA205181
Athletes Foot	BUTENAFINE HYDROCHLORIDE	STRATEGIC SOURCING SERVICES LLC	b4913a89-56fd-4710-b28e-6fb6d50fd3f3	2025-07-03	Warnings	Exact identifier application applno (ANDA): 205181 application number: ANDA205181
Athletes Foot	BUTENAFINE HYDROCHLORIDE	Target Corporation	59494e7f-fd70-4a60-bb1d-4a5ffee945c1	2025-07-03	Warnings	Exact identifier application applno (ANDA): 205181 application number: ANDA205181
Athletes Foot	BUTENAFINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	3e976ed8-2af8-4d1e-bda6-e2f672c7ec03	2025-07-03	Warnings	Exact identifier application applno (ANDA): 205181 application number: ANDA205181
Athletes Foot	BUTENAFINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	4b400be5-acaa-4a5f-b8ef-c0df8ad6175f	2025-07-03	Warnings	Exact identifier application applno (ANDA): 205181 application number: ANDA205181
Athletes Foot	BUTENAFINE HYDROCHLORIDE	Walgreen Company	4ce8cba1-d637-42c0-8b8b-79bb117b2cd1	2025-07-03	Warnings	Exact identifier application applno (ANDA): 205181 application number: ANDA205181
Athletes Foot Ultra	BUTENAFINE HYDROCHLORIDE	H E B	0841f741-6409-4d93-a6a7-901808f77bcd	2025-07-03	Warnings	Exact identifier application applno (ANDA): 205181 application number: ANDA205181
Athletes Foot Ultra	BUTENAFINE HYDROCHLORIDE	Wal-Mart Stores Inc	a77a2694-04e7-4b37-ac6a-34f896945912	2025-07-03	Warnings	Exact identifier application applno (ANDA): 205181 application number: ANDA205181
Butenafine Hydrochloride	BUTENAFINE HYDROCHLORIDE	MEIJER DISTRIBUTION INC	4e88068b-1449-43b4-9c7c-4ad8e877459b	2025-07-03	Warnings	Exact identifier application applno (ANDA): 205181 application number: ANDA205181
Butenafine Hydrochloride 1%	BUTENAFINE HYDROCHLORIDE	CVS Pharmacy	83830b24-bc94-4764-a6ca-3193abd9de66	2025-07-03	Warnings	Exact identifier application applno (ANDA): 205181 application number: ANDA205181
Butenafine Hydrochloride Athletes Foot	BUTENAFINE HYDROCHLORIDE	Kroger Company	2af91428-3fb9-4974-a55f-87aad750d05b	2025-07-03	Warnings	Exact identifier application applno (ANDA): 205181 application number: ANDA205181
Butenafine Hydrochloride	BUTENAFINE HYDROCHLORIDE	Albertsons	098dee89-0f7b-4341-a691-bfe6077ff353	2025-07-03	Warnings	Exact identifier application applno (ANDA): 205181 application number: ANDA205181
Butenafine Hydrochloride Jock Itch	BUTENAFINE HYDROCHLORIDE	Wal-Mart Stores Inc	be9a411c-55d7-4db5-a420-30013efbbc24	2025-07-03	Warnings	Exact identifier application applno (ANDA): 205181 application number: ANDA205181
Jock Itch	BUTENAFINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	14a23a39-b567-4db4-bac0-c008c0ca6171	2025-07-03	Warnings	Exact identifier application applno (ANDA): 205181 application number: ANDA205181
Jock Itch Cream	BUTENAFINE HYDROCHLORIDE	TARGET CORPORATION	1d8a17ae-4e25-f591-e063-6394a90a35dd	2025-07-03	Warnings	Exact identifier application applno (ANDA): 205181 application number: ANDA205181
Jock Itch	BUTENAFINE HYDROCHLORIDE	Walgreen Company	6b13e8ad-b7dd-49e7-9469-3cac077c763e	2025-07-03	Warnings	Exact identifier application applno (ANDA): 205181 application number: ANDA205181

Additional Listing Data#

Finished product: Yes
Brand name base: Butenafine Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUTENAFINE HYDROCHLORIDE	10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
R8XA2029ZI	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1298448	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
e650d8aa-c809-42ee-a1d9-a6321d5364f5	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73581-210-02	Butenafine Hydrochloride	1 in 1 CARTON	CREAM	1		4
73581-210-02	Butenafine Hydrochloride	30 g in 1 TUBE	CREAM	30		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73581-210	BUTENAFINE HYDROCHLORIDE CREAM [YYBA CORP]	2	Current NDC, 2 package rows	20241212_e650d8aa-c809-42ee-a1d9-a6321d5364f5.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R8XA2029ZI	BUTENAFINE HYDROCHLORIDE	101827-46-7	BUTENAFINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1298448	butenafine HCl 1 % Topical Cream	PSN	e650d8aa-c809-42ee-a1d9-a6321d5364f5	4
1298448	butenafine hydrochloride 10 MG/ML Topical Cream	SCD	e650d8aa-c809-42ee-a1d9-a6321d5364f5	4
1298448	butenafine HCl 1 % Topical Cream	SY	e650d8aa-c809-42ee-a1d9-a6321d5364f5	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
73581-210-02	73581021002	1 TUBE in 1 CARTON (73581-210-02) / 30 g in 1 TUBE	1 tube	2023-10-12	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Welmate Butenafine 73581-210	YYBA CORP \| Sun Pharma Canada Inc.	2025-12-10	HUMAN OTC DRUG LABEL	4