hair regrowth treatment

Product NDC: 21130-611
Requested package NDC: 21130-611-30
11-digit product format: 211300611
Labeler code: 21130
Product ID: 21130-611_4eaefc19-eda6-46e4-a56e-93a1787e4bd2
Type: HUMAN OTC DRUG
Nonproprietary name: minoxidil
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Safeway
Application: ANDA075598
Marketing category: ANDA
Marketing start: 2024-08-13
Substance: MINOXIDIL
Active strength: 5 g/100mL
Pharmacologic classes: Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	MINOXIDIL	5%	SOLUTION / TOPICAL			2001-06-13

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	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`cb3db0bc1861…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
up and up hair regrowth treatment for men	MINOXIDIL	Target Corporation	545e3e21-6333-4d85-8754-b7a6201234b7	2026-04-09	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598
Loesch Hair Regrowth Formula Unscented Topical Solution Extra-Strength for Men	MINOXIDIL	Loesch Laboratory Consultant, INC.	d158d3af-6850-48c0-8355-9df0637684cc	2025-12-03	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598
hair regrowth treatment	MINOXIDIL	Rite Aid Corporation	00c83180-0e13-4a07-9ce8-a9cae19a79a3	2025-10-08	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598
minoxidil	MINOXIDIL	Publix Super Markets Inc	57699890-6fef-4bd8-b690-161458131cd7	2025-08-12	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598
hair regrowth treatment	MINOXIDIL	Walgreen Company	fb2a8bfe-7eae-4a78-a610-58c9e80adf72	2025-07-17	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598
Hair Regrowth Treatment	MINOXIDIL	CVS Pharmacy	7041e548-e3ff-4623-8c35-783c64d5f04c	2025-05-22	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598
members mark hair regrowth treatment	MINOXIDIL	Sam's West Inc	b3377092-b00d-4ab0-b62e-acd108dc330c	2025-05-22	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598
minoxidil	MINOXIDIL	THIRTY MADISON INC	9a8528df-3cd3-4c85-b7e9-0a0e761d6cbd	2025-05-20	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598
hair regrowth treatment	MINOXIDIL	Kroger Company	3cacbf09-243e-4f5c-9878-4e191c0dd92a	2025-02-05	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598
hims hair regrowth treatment	MINOXIDIL	Hims Inc	c3caf0cd-9148-4696-9cb8-ec93cab3f9f5	2025-02-05	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598
hair regrowth treatment	MINOXIDIL	Meijer, Inc.	847ec102-ee04-4168-9b85-c66bb01a1161	2025-02-05	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598
kirkland signature minoxidil	MINOXIDIL	Costco Wholesale Company	ec4b79fd-f68b-4f8d-a173-983835bc82eb	2025-02-04	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598
equate hair regrowth treatment	MINOXIDIL	WALMART INC.	d57919c3-c6e1-4d84-bfa5-d4159d1c6c48	2024-09-23	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598
hair regrowth treatment	MINOXIDIL	Safeway	cc99123b-b1a3-4818-9a06-e64478871c16	2024-08-20	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598 ndc (package): 21130-611-30 ndc (product): 21130-611 ndc11 (package): 21130061130
kirkland signature minoxidil	MINOXIDIL	Costco Wholesale Company	010ca7df-1e79-44ea-9171-b9d239f141e1	2024-07-18	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598
Good Sense Hair Regrowth Treatment	MINOXIDIL	L. Perrigo Company	a3bfdd6f-2b41-406e-8a20-c1e5de0c186b	2024-07-18	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598
minoxidil	MINOXIDIL	H E B	a05bc954-d369-4eb6-8a7d-d68955af874f	2024-05-13	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598
basic care hair regrowth treatment	MINOXIDIL	Amazon.com Services LLC	9d5e7acb-3892-4163-9f44-26e430959aa7	2024-04-23	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598
Leader Minoxidil	MINOXIDIL	Cardinal Health 110, LLC. dba Leader	fbb17735-6c1f-44d6-865b-feec83a66b69	2024-03-04	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598
equate hair regrowth treatment	MINOXIDIL	Wal-Mart Stores Inc	98f780ad-dc07-4d37-a05d-fc7b45b0c474	2021-09-29	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598

Additional Listing Data#

Finished product: Yes
Brand name base: hair regrowth treatment
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MINOXIDIL	5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5965120SH1	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311724	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
cc99123b-b1a3-4818-9a06-e64478871c16	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21130-611-16	hair regrowth treatment	1 in 1 CARTON	SOLUTION	1	2
21130-611-16	hair regrowth treatment	60 mL in 1 BOTTLE	SOLUTION	60	2
21130-611-30	hair regrowth treatment	3 in 1 CARTON	SOLUTION	3	2
21130-611-30	hair regrowth treatment	60 mL in 1 BOTTLE	SOLUTION	60	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21130-611	HAIR REGROWTH TREATMENT (MINOXIDIL) SOLUTION [SAFEWAY]	2	Current NDC, 4 package rows	20240823_cc99123b-b1a3-4818-9a06-e64478871c16.zip

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	cc99123b-b1a3-4818-9a06-e64478871c16	2
311724	minoxidil 50 MG/ML Topical Solution	SCD	cc99123b-b1a3-4818-9a06-e64478871c16	2
311724	minoxidil 3 GM per 60 ML Topical Solution	SY	cc99123b-b1a3-4818-9a06-e64478871c16	2
311724	minoxidil 5 % Topical Solution	SY	cc99123b-b1a3-4818-9a06-e64478871c16	2
311724	minoxidil 5 GM per 100 ML Topical Solution	SY	cc99123b-b1a3-4818-9a06-e64478871c16	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
21130-611-30	21130061130	3 BOTTLE in 1 CARTON (21130-611-30) / 60 mL in 1 BOTTLE	3 bottle	2024-08-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Better Living Brands LLC Hair Regrowth Treatment Drug Facts	Safeway	2024-08-20	HUMAN OTC DRUG LABEL	2