minoxidil

Product NDC: 0472-1660
Requested package NDC: 0472-1660-85
11-digit product format: 004721660
Labeler code: 0472
Product ID: 0472-1660_d4cf7957-b93c-4b76-bd33-b7583d784590
Type: HUMAN OTC DRUG
Nonproprietary name: minoxidil
Dosage form: AEROSOL, FOAM
Route: TOPICAL
Labeler: Actavis Pharma, Inc.
Application: ANDA208092
Marketing category: ANDA
Marketing start: 2017-03-31
Marketing end: 2021-12-31
Substance: MINOXIDIL
Active strength: 5 g/100g
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0472-1660	0472-1660-85	D	Discontinued by firm		2026-08-03

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208092-001	MINOXIDIL (FOR MEN)	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL			2017-02-17
A208092-002	MINOXIDIL (FOR WOMEN)	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL			2017-07-27

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`782e0a99824c…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Minoxidil	MINOXIDIL	P & L Development, LLC	869ce741-3094-4123-9059-0669f3591b2f	2026-07-21	Warnings	Exact identifier application applno (ANDA): 208092 application number: ANDA208092
Minoxidil For Women	MINOXIDIL	BosleyMD	ebda6e49-140c-4ab0-b155-5ed501ef3e8a	2026-03-24	Warnings	Exact identifier application applno (ANDA): 208092 application number: ANDA208092
Minoxidil For Men	MINOXIDIL	BosleyMD	61c41686-81af-4000-94bc-3cf9e71b0f18	2026-03-24	Warnings	Exact identifier application applno (ANDA): 208092 application number: ANDA208092
Minoxidil	MINOXIDIL	P & L Development, LLC	204bab15-47c5-449c-a889-700914b04b61	2026-03-03	Warnings	Exact identifier application applno (ANDA): 208092 application number: ANDA208092
Minoxidil	MINOXIDIL	P & L Development, LLC	04373c29-85f3-4d7d-bbdd-950dcf1a879a	2026-03-03	Warnings	Exact identifier application applno (ANDA): 208092 application number: ANDA208092
Minoxidil	MINOXIDIL	Keranique	4af782f4-68d5-4338-a0a6-85d11a23ce98	2025-10-07	Warnings	Exact identifier application applno (ANDA): 208092 application number: ANDA208092
Minoxidil	MINOXIDIL	P & L Development, LLC	59e7cdae-6595-4aa2-8fe0-7a8bcf300912	2024-11-05	Warnings	Exact identifier application applno (ANDA): 208092 application number: ANDA208092
Minoxidil	MINOXIDIL	P & L Development, LLC	73dc7e7f-92c2-4ab2-a260-ceb198e591cf	2024-11-05	Warnings	Exact identifier application applno (ANDA): 208092 application number: ANDA208092

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5965120SH1	MINOXIDIL	38304-91-5	MINOXIDIL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0472-1660-85	00472166085	2 CAN in 1 CARTON (0472-1660-85) > 60 g in 1 CAN	2 can	2017-03-31	2021-12-31	No	No	Current