Jock Itch

Product NDC: 51672-2101
11-digit product format: 516722101
Labeler code: 51672
Product ID: 51672-2101_a0159f92-c609-486b-a727-bc4d431ed8eb
Type: HUMAN OTC DRUG
Nonproprietary name: Butenafine Hydrochloride
Dosage form: CREAM
Route: TOPICAL
Labeler: Taro Pharmaceuticals U.S.A., inc.
Application: ANDA205181
Marketing category: ANDA
Marketing start: 2017-11-17
Marketing end: 0000-00-00
Substance: BUTENAFINE HYDROCHLORIDE
Active strength: 10 mg/g
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	51672-2101		D	Discontinued by firm	2026-10-30
excluded package	package	51672-2101	51672-2101-1	D	Discontinued by firm	2026-10-30
excluded package	package	51672-2101	51672-2101-2	D	Discontinued by firm	2026-10-30
excluded package	package	51672-2101	51672-2101-8	D	Discontinued by firm	2026-10-30
excluded package	package	51672-2101	51672-2101-9	D	Discontinued by firm	2026-10-30

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205181-001	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2017-11-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51672-2101-1	Jock Itch	1 in 1 CARTON	CREAM	1	6
51672-2101-1	Jock Itch	15 g in 1 TUBE	CREAM	15	6
51672-2101-2	Jock Itch	1 in 1 CARTON	CREAM	1	6
51672-2101-2	Jock Itch	30 g in 1 TUBE	CREAM	30	6
51672-2101-8	Jock Itch	1 in 1 CARTON	CREAM	1	6
51672-2101-8	Jock Itch	12 g in 1 TUBE	CREAM	12	6
51672-2101-9	Jock Itch	1 in 1 CARTON	CREAM	1	6
51672-2101-9	Jock Itch	24 g in 1 TUBE	CREAM	24	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51672-2101	JOCK ITCH (BUTENAFINE HYDROCHLORIDE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	4	Legacy NDC, 8 package rows	20171121_14a23a39-b567-4db4-bac0-c008c0ca6171.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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Butenafine Hydrochloride	BUTENAFINE HYDROCHLORIDE	MEIJER DISTRIBUTION INC	4e88068b-1449-43b4-9c7c-4ad8e877459b	2026-09-03	Warnings	Exact identifier application applno (ANDA): 205181 application number: ANDA205181
Butenafine Hydrochloride	BUTENAFINE HYDROCHLORIDE	YYBA CORP	e650d8aa-c809-42ee-a1d9-a6321d5364f5	2025-12-10	Warnings	Exact identifier application applno (ANDA): 205181 application number: ANDA205181
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 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 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

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	14a23a39-b567-4db4-bac0-c008c0ca6171	6
1298448	butenafine hydrochloride 10 MG/ML Topical Cream	SCD	14a23a39-b567-4db4-bac0-c008c0ca6171	6
1298448	butenafine HCl 1 % Topical Cream	SY	14a23a39-b567-4db4-bac0-c008c0ca6171	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51672-2101-1	51672210101	1 TUBE in 1 CARTON (51672-2101-1) > 15 g in 1 TUBE	1 tube	2017-11-17	0000-00-00	No	No	Current
51672-2101-2	51672210102	1 TUBE in 1 CARTON (51672-2101-2) > 30 g in 1 TUBE	1 tube	2017-11-17	0000-00-00	No	No	Current
51672-2101-8	51672210108	1 TUBE in 1 CARTON (51672-2101-8) > 12 g in 1 TUBE	1 tube	2017-11-17	0000-00-00	No	No	Current
51672-2101-9	51672210109	1 TUBE in 1 CARTON (51672-2101-9) > 24 g in 1 TUBE	1 tube	2017-11-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Jock Itch Cream	Sun Pharmaceutical Industries, Inc. \| Sun Pharma Canada Inc.	2025-07-03	HUMAN OTC DRUG LABEL	6