Minoxidil

Product NDC: 55301-094
Requested package NDC: 55301-094-73
11-digit product format: 553010094
Labeler code: 55301
Product ID: 55301-094_4affa828-fd78-4f1a-80e1-501e36595d6f
Type: HUMAN OTC DRUG
Nonproprietary name: Minoxidil
Dosage form: SOLUTION
Route: TOPICAL
Labeler: AAFES/Your Military Exchanges
Application: ANDA075518
Marketing category: ANDA
Marketing start: 2007-05-17
Marketing end: 0000-00-00
Substance: MINOXIDIL
Active strength: 50 mg/mL
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	55301-094	55301-094-73	D	Discontinued by firm		2026-11-13

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 45.

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
A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	MINOXIDIL	5%	SOLUTION / TOPICAL			2000-11-17

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 · 45 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-11-14 07:37:17	2026-10	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`3bdfa0b2c4d7…`

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
55301-094-73	2023-07-19	C162847	48780-1	f386c649-b213-0266-e053-dadaa90a7c1a	Minoxidil Topical Solution for Men
55301-094-73	2023-01-30	C162847	48780-1	f386c649-b213-0266-e053-dadaa90a7c1a	Minoxidil Topical Solution for Men

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MINOXIDIL	ACTIVE INGREDIENT	5965120SH1	HAIR REGROWTH TREATMENT FOR MEN EXTRA STRENGTH (MINOXIDIL) SOLUTION [ARMY AND AIR FORCE EXCHANGE SERVICE]	3
MINOXIDIL	ACTIVE MOIETY	5965120SH1	HAIR REGROWTH TREATMENT FOR MEN EXTRA STRENGTH (MINOXIDIL) SOLUTION [ARMY AND AIR FORCE EXCHANGE SERVICE]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	HAIR REGROWTH TREATMENT FOR MEN EXTRA STRENGTH (MINOXIDIL) SOLUTION [ARMY AND AIR FORCE EXCHANGE SERVICE]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HAIR REGROWTH TREATMENT FOR MEN EXTRA STRENGTH (MINOXIDIL) SOLUTION [ARMY AND AIR FORCE EXCHANGE SERVICE]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	HAIR REGROWTH TREATMENT FOR MEN EXTRA STRENGTH (MINOXIDIL) SOLUTION [ARMY AND AIR FORCE EXCHANGE SERVICE]	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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Minoxidil	MINOXIDIL	Walgreens	a08edb99-3e45-4d3c-a0f8-c74bd291057a	2025-01-28	Warnings	Exact identifier application applno (ANDA): 075518 application number: ANDA075518

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	Marketing start	Marketing end	Sample	Exclude flag	Status
55301-094-73	55301009473	1 BOTTLE, DROPPER in 1 CARTON (55301-094-73) > 60 mL in 1 BOTTLE, DROPPER	2007-05-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Minoxidil Topical Solution for Men	AAFES/Your Military Exchanges	2023-07-19	HUMAN OTC DRUG LABEL	9