Minoxidil

Product NDC: 61269-094
11-digit product format: 612690094
Labeler code: 61269
Product ID: 61269-094_4162d466-6dd6-406e-ba78-253eb04f394b
Type: HUMAN OTC DRUG
Nonproprietary name: Minoxidil
Dosage form: SOLUTION
Route: TOPICAL
Labeler: H2-Pharma, LLC
Application: ANDA075518
Marketing category: ANDA
Marketing start: 2022-04-25
Marketing end: 0000-00-00
Substance: MINOXIDIL
Active strength: 5 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61269-094		D	Discontinued by firm	2026-08-17
excluded package	package	61269-094	61269-094-73	D	Discontinued by firm	2026-08-17
excluded package	package	61269-094	61269-094-75	D	Discontinued by firm	2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075518-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61269-094-73	ML - Milliliter	61269-094	34fdfb1d-8fb7-487a-80ef-e0b71df5c207	1	2022-05-04
61269-094-75	ML - Milliliter	61269-094	714c4010-70ff-4e95-a90a-034510ca8eea	1	2022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61269-094	MINOXIDIL SOLUTION [H2-PHARMA, LLC]	2	Legacy NDC	20250101_f33502d3-e330-48d1-a38e-b98cf0b14b61.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hair Regrowth Treatment Extra Strength for Men	MINOXIDIL	Seiseidou America, Inc.	1bcb9934-861c-405a-948a-3e4cdd13246d	2025-10-08	Warnings	Exact identifier application applno (ANDA): 075518 application number: ANDA075518
Minoxidil	MINOXIDIL	Walgreens	a08edb99-3e45-4d3c-a0f8-c74bd291057a	2025-01-28	Warnings	Exact identifier application applno (ANDA): 075518 application number: ANDA075518
Minoxidil	MINOXIDIL	Walgreens	97d4d3ce-316c-4d58-b4dc-28d662b0fb4a	2023-10-11	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
61269-094-73	61269009473	1 BOTTLE, DROPPER in 1 CARTON (61269-094-73) > 60 mL in 1 BOTTLE, DROPPER	2022-04-25	0000-00-00	No	No	Current
61269-094-75	61269009475	2 BOTTLE, DROPPER in 1 CARTON (61269-094-75) > 60 mL in 1 BOTTLE, DROPPER	2022-04-25	0000-00-00	No	No	Current