Minoxidil

Product NDC: 68016-006
11-digit product format: 680160006
Labeler code: 68016
Product ID: 68016-006_45b26231-d780-490d-b50d-fac294807c87
Type: HUMAN OTC DRUG
Nonproprietary name: Minoxidil
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Chain Drug Consortium, LLC
Application: ANDA074588
Marketing category: ANDA
Marketing start: 2000-01-01
Marketing end: 0000-00-00
Substance: MINOXIDIL
Active strength: 2 g/100mL
Pharmacologic classes: Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	68016-006		D	Discontinued by firm		2026-08-03
excluded package	package	68016-006	68016-006-64	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 · 14 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	68016-006-64	`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	68016-006-64	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68016-006-64	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68016-006-64	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68016-006-64	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68016-006-64	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68016-006-64	`302b2466d912…`	`e7b80fea0513…`

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
68016-006-64	ML - Milliliter	68016-006	931f55e3-3cc3-404b-9a1e-29852854393d	1	2022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MINOXIDIL	ACTIVE INGREDIENT	5965120SH1	HAIR REGROWTH TREATMENT FOR WOMEN (MINOXIDIL) SOLUTION [CHAIN DRUG CONSORTIUM, LLC]	2
MINOXIDIL	ACTIVE MOIETY	5965120SH1	HAIR REGROWTH TREATMENT FOR WOMEN (MINOXIDIL) SOLUTION [CHAIN DRUG CONSORTIUM, LLC]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	HAIR REGROWTH TREATMENT FOR WOMEN (MINOXIDIL) SOLUTION [CHAIN DRUG CONSORTIUM, LLC]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HAIR REGROWTH TREATMENT FOR WOMEN (MINOXIDIL) SOLUTION [CHAIN DRUG CONSORTIUM, LLC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	HAIR REGROWTH TREATMENT FOR WOMEN (MINOXIDIL) SOLUTION [CHAIN DRUG CONSORTIUM, LLC]	2

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
68016-006-64	68016000664	2 BOTTLE, DROPPER in 1 CARTON (68016-006-64) > 60 mL in 1 BOTTLE, DROPPER	2000-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Minoxidil Topical Solution for Women	Chain Drug Consortium, LLC	2022-11-21	HUMAN OTC DRUG LABEL	7