Minoxidil

Product NDC: 70550-116
11-digit product format: 705500116
Labeler code: 70550
Product ID: 70550-116_9a10e5d1-3def-4521-bf64-a8e3029a73a2
Type: HUMAN OTC DRUG
Nonproprietary name: Minoxidil
Dosage form: AEROSOL, FOAM
Route: TOPICAL
Labeler: Keranique
Application: ANDA208092
Marketing category: ANDA
Marketing start: 2024-03-15
Substance: MINOXIDIL
Active strength: 50 mg/g
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 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208092-001	MINOXIDIL (FOR MEN)	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL			2017-02-17
A208092-002	MINOXIDIL (FOR WOMEN)	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL			2017-07-27

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`74a2ff9319b5…`

Additional Listing Data#

Finished product: Yes
Brand name base: Minoxidil
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MINOXIDIL	50 mg/g

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
645146	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
4af782f4-68d5-4338-a0a6-85d11a23ce98	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70550-116-02	Minoxidil	1 in 1 PACKAGE	AEROSOL, FOAM	1	6
70550-116-02	Minoxidil	60 g in 1 CAN	AEROSOL, FOAM	60	6
70550-116-20	Minoxidil	60 g in 1 CAN	AEROSOL, FOAM	60	6
70550-116-20	Minoxidil	2 in 1 PACKAGE	AEROSOL, FOAM	2	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70550-116	MINOXIDIL AEROSOL, FOAM [PROFECTUS BEAUTY, LLC]	5	Current NDC, 4 package rows	20240316_4af782f4-68d5-4338-a0a6-85d11a23ce98.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Minoxidil	MINOXIDIL	Keranique	4af782f4-68d5-4338-a0a6-85d11a23ce98	2026-08-18	Warnings	Exact identifier application applno (ANDA): 208092 application number: ANDA208092 ndc (product): 70550-116
Minoxidil	MINOXIDIL	P & L Development, LLC	869ce741-3094-4123-9059-0669f3591b2f	2026-08-06	Warnings	Exact identifier application applno (ANDA): 208092 application number: ANDA208092
Minoxidil For Women	MINOXIDIL	BosleyMD	ebda6e49-140c-4ab0-b155-5ed501ef3e8a	2026-03-24	Warnings	Exact identifier application applno (ANDA): 208092 application number: ANDA208092
Minoxidil For Men	MINOXIDIL	BosleyMD	61c41686-81af-4000-94bc-3cf9e71b0f18	2026-03-24	Warnings	Exact identifier application applno (ANDA): 208092 application number: ANDA208092
Minoxidil	MINOXIDIL	P & L Development, LLC	204bab15-47c5-449c-a889-700914b04b61	2026-03-03	Warnings	Exact identifier application applno (ANDA): 208092 application number: ANDA208092
Minoxidil	MINOXIDIL	P & L Development, LLC	04373c29-85f3-4d7d-bbdd-950dcf1a879a	2026-03-03	Warnings	Exact identifier application applno (ANDA): 208092 application number: ANDA208092
Minoxidil	MINOXIDIL	P & L Development, LLC	59e7cdae-6595-4aa2-8fe0-7a8bcf300912	2024-11-05	Warnings	Exact identifier application applno (ANDA): 208092 application number: ANDA208092
Minoxidil	MINOXIDIL	P & L Development, LLC	73dc7e7f-92c2-4ab2-a260-ceb198e591cf	2024-11-05	Warnings	Exact identifier application applno (ANDA): 208092 application number: ANDA208092

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
645146	minoxidil 5 % Topical Foam	PSN	4af782f4-68d5-4338-a0a6-85d11a23ce98	6
645146	minoxidil 50 MG/ML Topical Foam	SCD	4af782f4-68d5-4338-a0a6-85d11a23ce98	6
645146	minoxidil 5 % Topical Foam	SY	4af782f4-68d5-4338-a0a6-85d11a23ce98	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70550-116-02	70550011602	1 CAN in 1 PACKAGE (70550-116-02) / 60 g in 1 CAN	1 can	2024-03-15	No	No	Current
70550-116-20	70550011620	2 CAN in 1 PACKAGE (70550-116-20) / 60 g in 1 CAN	2 can	2024-03-15	No	No	Current