Minoxidil

Product NDC: 0472-0066
Requested package NDC: 0472-0066-75
11-digit product format: 004720066
Labeler code: 0472
Product ID: 0472-0066_bae3e6a5-32b5-4dd3-a6f3-c33ca814ce34
Type: HUMAN OTC DRUG
Nonproprietary name: Minoxidil
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Actavis Pharma, Inc.
Application: ANDA074588
Marketing category: ANDA
Marketing start: 1996-04-05
Marketing end: 0000-00-00
Substance: MINOXIDIL
Active strength: 2 g/100mL
NDC exclude flag: No
Listing certified through: 2022-12-31
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	0472-0066	0472-0066-75	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074588-001	MINOXIDIL (FOR MEN)	MINOXIDIL	2%	SOLUTION / TOPICAL			1996-04-05

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 · 41 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	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0472-0066-73	ML - Milliliter	0472-0066	36146d23-da0f-48db-8802-cfb22aa18bf7	1	2012-07-24
0472-0066-75	ML - Milliliter	0472-0066	b976b16e-a49a-47af-b655-9035f9ce0433	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MINOXIDIL	ACTIVE INGREDIENT	5965120SH1	HAIR REGROWTH TREATMENT (MINOXIDIL) SOLUTION [ACTAVIS MID ATLANTIC LLC]	2
MINOXIDIL	ACTIVE MOIETY	5965120SH1	HAIR REGROWTH TREATMENT (MINOXIDIL) SOLUTION [ACTAVIS MID ATLANTIC LLC]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	HAIR REGROWTH TREATMENT (MINOXIDIL) SOLUTION [ACTAVIS MID ATLANTIC LLC]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HAIR REGROWTH TREATMENT (MINOXIDIL) SOLUTION [ACTAVIS MID ATLANTIC LLC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	HAIR REGROWTH TREATMENT (MINOXIDIL) SOLUTION [ACTAVIS MID ATLANTIC LLC]	2
MINOXIDIL	ACTIVE INGREDIENT	5965120SH1	MINOXIDIL SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
MINOXIDIL	ACTIVE MOIETY	5965120SH1	MINOXIDIL SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	MINOXIDIL SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	MINOXIDIL SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	MINOXIDIL SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1

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	b55198cb-40d8-432b-bdd5-2ecefa35d320	2025-05-21	Warnings	Exact identifier application applno (ANDA): 074588 application number: ANDA074588

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311723	minoxidil 2 % Topical Solution	PSN	c4a1790c-9487-4f16-b3cb-4eaf18e5984d	1
311723	minoxidil 20 MG/ML Topical Solution	SCD	c4a1790c-9487-4f16-b3cb-4eaf18e5984d	1
311723	minoxidil 2 % Topical Solution	SY	c4a1790c-9487-4f16-b3cb-4eaf18e5984d	1
311723	minoxidil 2 GM per 100 ML Topical Solution	SY	c4a1790c-9487-4f16-b3cb-4eaf18e5984d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0472-0066-75	00472006675	2 BOTTLE, DROPPER in 1 CARTON (0472-0066-75) > 60 mL in 1 BOTTLE, DROPPER	1996-04-05	2022-07-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Minoxidil Topical Solution for Men	Actavis Pharma, Inc.	2021-10-19	HUMAN OTC DRUG LABEL	8
Minoxidil Topical Solution for Men	Proficient Rx LP	2020-10-01	HUMAN OTC DRUG LABEL	1
Minoxidil Topical Solution 2% (For Men)	Physicians Total Care, Inc.	2012-10-02	HUMAN OTC DRUG LABEL	1