Hair Regrowth Treatment

Product NDC: 82269-607
11-digit product format: 822690607
Labeler code: 82269
Product ID: 82269-607_669593ec-e5b3-42a8-97ac-e4b8a75f56aa
Type: HUMAN OTC DRUG
Nonproprietary name: Minoxidil
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Seiseidou America, Inc.
Application: ANDA075518
Marketing category: ANDA
Marketing start: 2021-10-15
Marketing end: 0000-00-00
Substance: MINOXIDIL
Active strength: 50 mg/mL
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	82269-607		D	Discontinued by firm		2026-10-20
excluded package	package	82269-607	82269-607-02	D	Discontinued by firm		2026-10-20

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82269-607-02	Hair Regrowth TreatmentExtra Strength for Men	1 in 1 CARTON	SOLUTION	1		3
82269-607-02	Hair Regrowth TreatmentExtra Strength for Men	60 mL in 1 BOTTLE, DROPPER	SOLUTION	60		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82269-607	HAIR REGROWTH TREATMENT EXTRA STRENGTH FOR MEN (MINOXIDIL) SOLUTION [SEISEIDOU AMERICA, INC.]	2	Legacy NDC, 2 package rows	20221109_1bcb9934-861c-405a-948a-3e4cdd13246d.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	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311724	minoxidil 5 % Topical Solution	PSN	1bcb9934-861c-405a-948a-3e4cdd13246d	3
311724	minoxidil 50 MG/ML Topical Solution	SCD	1bcb9934-861c-405a-948a-3e4cdd13246d	3
311724	minoxidil 3 GM per 60 ML Topical Solution	SY	1bcb9934-861c-405a-948a-3e4cdd13246d	3
311724	minoxidil 5 % Topical Solution	SY	1bcb9934-861c-405a-948a-3e4cdd13246d	3
311724	minoxidil 5 GM per 100 ML Topical Solution	SY	1bcb9934-861c-405a-948a-3e4cdd13246d	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
82269-607-02	82269060702	1 BOTTLE, DROPPER in 1 CARTON (82269-607-02) > 60 mL in 1 BOTTLE, DROPPER	2021-10-15	0000-00-00	No	No	Current