Minoxidil

Product NDC: 71205-490
11-digit product format: 712050490
Labeler code: 71205
Product ID: 71205-490_56da6b01-5580-4adc-b33c-981eaeb4007f
Type: HUMAN OTC DRUG
Nonproprietary name: Minoxidil
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Proficient Rx LP
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: 2021-12-31
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	71205-490		D	Discontinued by firm		2026-08-03
excluded package	package	71205-490	71205-490-02	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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71205-490-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71205-490-02	`f5e01cc5f278…`	`a2eaf40c39c3…`

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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-490	MINOXIDIL REGULAR STRENGTH FOR MEN (MINOXIDIL) SOLUTION [PROFICIENT RX LP]	1	Legacy NDC	20201031_56da6b01-5580-4adc-b33c-981eaeb4007f.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-490-02	71205049002	2 BOTTLE, DROPPER in 1 CARTON (71205-490-02) > 60 mL in 1 BOTTLE, DROPPER	2020-10-19	0000-00-00	No	No	Current