MENS alopexy

Product NDC: 64760-602
11-digit product format: 647600602
Labeler code: 64760
Product ID: 64760-602_70bd1712-d290-4c9b-8c0d-919354a5c489
Type: HUMAN OTC DRUG
Nonproprietary name: minoxidil
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Genesis Pharmaceutical, Inc.
Application: ANDA076239
Marketing category: ANDA
Marketing start: 2016-08-08
Marketing end: 0000-00-00
Substance: MINOXIDIL
Active strength: 50 mg/mL
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	64760-602		D	Discontinued by firm		2026-10-15
excluded package	package	64760-602	64760-602-03	D	Discontinued by firm		2026-10-15

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 · 38 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64760-602-03	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64760-602-03	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64760-602-03	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64760-602-03	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64760-602-03	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64760-602-03	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64760-602-03	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64760-602-03	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64760-602-03	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64760-602-03	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64760-602-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64760-602-03	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	64760-602-03	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	64760-602-03	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	64760-602-03	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	64760-602-03	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	64760-602-03	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	64760-602-03	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	64760-602-03	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
A076239-001	THEROXIDIL	MINOXIDIL	5%	SOLUTION / TOPICAL			2004-08-24

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	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
64760-602-03	2023-04-28	C162847	48780-1	9d75b9d0-7879-f424-e053-dadaa90a57ce	MEN'S alopexy 5% - 3 month supply
64760-602-03	2020-01-31	C162847	48780-1	9d75b9d0-7879-f424-e053-dadaa90a57ce	MEN'S alopexy 5% - 3 month supply

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 2 of 2 · 30 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tomum Hair Growth Treatment For Men Minoxidil Unscented	MINOXIDIL	BELLEKA INC	4c0582a3-f2be-4e53-a174-12269f7ddad0	2024-12-04	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239
Colorsmith Hair Regrowth Treatment Mens Minoxidil Topical Solution Extra Strength	MINOXIDIL	ESALON.COM, LLC	69b01eab-df9f-4ae8-87e4-add18883874b	2024-11-05	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239
Elevate Hair Regrowth Treatment 5	MINOXIDIL	VAPOR PRO SHOPPE, LLC	0d5e4258-a58d-4378-9be8-631114588cdb	2024-10-31	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239
DAVV Minoxidil Topical Solution Mens Hair Regrowth Treatment	MINOXIDIL	Good Manager Holdings Inc	16b36a38-72c3-4a19-a28c-757ae02e097a	2024-10-28	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239
Elevate Hair Regrowth Treatment 5 Minoxidil Solution	MINOXIDIL	VAPOR PRO SHOPPE, LLC	12737299-1052-4c93-afab-20016b9d9001	2024-07-22	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239
GROWELL Mens Hair Regrowth Treatment 5 Minoxidil	MINOXIDIL	APIRA SCIENCE, INC.	8cd4a3a9-94ba-48c7-8516-b50504c2c440	2024-05-16	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239
BOSLEY Minoxidil Topical Solution 5 (for men)	MINOXIDIL	Scientific Hair Research, LLC	90d96eb1-a478-42ce-9389-642c57bbf280	2024-05-01	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239
BOSLEY Man 5 Minoxidil Topical Solution	MINOXIDIL	Scientific Hair Research, LLC	c692b47d-12c3-4225-9eee-b08ca76e4daa	2023-10-26	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239
SUAVECITO 5% Minoxidil Solution	MINOXIDIL	SUAVECITO, INC.	a6d3c488-f943-4edf-9d6b-21a3dee92d78	2023-07-18	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239
Regenpure Precision	MINOXIDIL	Salonceuticals, Inc.	4a113921-b2a9-42cc-e054-00144ff8d46c	2017-03-06	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239