minoxidil

Product NDC: 0363-0294
Requested package NDC: 0363-0294-01
11-digit product format: 003630294
Labeler code: 0363
Product ID: 0363-0294_84cb99a4-38ec-4e48-b96d-d01964abf10b
Type: HUMAN OTC DRUG
Nonproprietary name: Minoxidil
Dosage form: AEROSOL, FOAM
Route: TOPICAL
Labeler: Walgreen Company
Application: ANDA091344
Marketing category: ANDA
Marketing start: 2012-03-01
Marketing end: 0000-00-00
Substance: MINOXIDIL
Active strength: 5 g/100g
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0363-0294	0363-0294-01	D	Discontinued by firm		2026-10-16

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 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
A091344-001	MINOXIDIL	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL			2011-04-28

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	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MINOXIDIL	ACTIVE INGREDIENT	5965120SH1	MINOXIDIL AEROSOL, FOAM [WALGREEN COMPANY]	3
MINOXIDIL	ACTIVE MOIETY	5965120SH1	MINOXIDIL AEROSOL, FOAM [WALGREEN COMPANY]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	MINOXIDIL AEROSOL, FOAM [WALGREEN COMPANY]	3
BUTANE	INACTIVE INGREDIENT	6LV4FOR43R	MINOXIDIL AEROSOL, FOAM [WALGREEN COMPANY]	3
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	MINOXIDIL AEROSOL, FOAM [WALGREEN COMPANY]	3
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	MINOXIDIL AEROSOL, FOAM [WALGREEN COMPANY]	3
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	MINOXIDIL AEROSOL, FOAM [WALGREEN COMPANY]	3
ISOBUTANE	INACTIVE INGREDIENT	BXR49TP611	MINOXIDIL AEROSOL, FOAM [WALGREEN COMPANY]	3
LACTIC ACID	INACTIVE INGREDIENT	33X04XA5AT	MINOXIDIL AEROSOL, FOAM [WALGREEN COMPANY]	3
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	MINOXIDIL AEROSOL, FOAM [WALGREEN COMPANY]	3
PROPANE	INACTIVE INGREDIENT	T75W9911L6	MINOXIDIL AEROSOL, FOAM [WALGREEN COMPANY]	3
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	MINOXIDIL AEROSOL, FOAM [WALGREEN COMPANY]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	MINOXIDIL AEROSOL, FOAM [WALGREEN COMPANY]	3

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 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
equate hair regrowth treatment	MINOXIDIL	Wal-Mart Stores Inc	b5327990-654f-4c1f-8cd4-95470f12d767	2022-03-09	Warnings	Exact identifier application applno (ANDA): 091344 application number: ANDA091344
Good Sense Hair Regrowth Treatment	MINOXIDIL	L. Perrigo Company	6f939158-eb96-4479-9a4a-f5a11aa88295	2021-09-13	Warnings	Exact identifier application applno (ANDA): 091344 application number: ANDA091344

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
0363-0294-01	00363029401	1 CAN in 1 CARTON (0363-0294-01) > 60 g in 1 CAN	1 can	2012-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Walgreen Co. Minoxidil Topical Aerosol, 5% (Foam) Drug Facts	Walgreen Company	2016-12-01	HUMAN OTC DRUG LABEL	5