Application 021812

Type: NDA
Sponsor: JOHNSON AND JOHNSON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MEN'S ROGAINE	MINOXIDIL	AEROSOL, FOAM;TOPICAL	5%	Yes	Yes
002	WOMEN'S ROGAINE	MINOXIDIL	AEROSOL, FOAM;TOPICAL	5%	Yes	Yes

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

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
N021812-001	MEN'S ROGAINE	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL		RLD, RS	2006-01-20
N021812-002	WOMEN'S ROGAINE	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL		RLD, RS	2014-02-28

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021812-001	MEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2006-01-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021812-002	WOMEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2014-02-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021812-001	MEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2006-01-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021812-002	WOMEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2014-02-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021812-001	MEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2006-01-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021812-002	WOMEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2014-02-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021812-001	MEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2006-01-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021812-002	WOMEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2014-02-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021812-001	MEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2006-01-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021812-002	WOMEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2014-02-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021812-001	MEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2006-01-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021812-002	WOMEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2014-02-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021812-001	MEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2006-01-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021812-002	WOMEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2014-02-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021812-001	MEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2006-01-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021812-002	WOMEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2014-02-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021812-001	MEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2006-01-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021812-002	WOMEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2014-02-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021812-001	MEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2006-01-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021812-002	WOMEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2014-02-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021812-001	MEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2006-01-20	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021812-002	WOMEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2014-02-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021812-001	MEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2006-01-20	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021812-002	WOMEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2014-02-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021812-001	MEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2006-01-20	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021812-002	WOMEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2014-02-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021812-001	MEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2006-01-20	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021812-002	WOMEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2014-02-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021812-001	MEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2006-01-20	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021812-002	WOMEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2014-02-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021812-001	MEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2006-01-20	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021812-002	WOMEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2014-02-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021812-001	MEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2006-01-20	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021812-002	WOMEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2014-02-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021812-001	MEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2006-01-20	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021812-002	WOMEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2014-02-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021812-001	MEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2006-01-20	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021812-002	WOMEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2014-02-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021812-001	MEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2006-01-20	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021812-002	WOMEN'S ROGAINE	5%	AEROSOL, FOAM / TOPICAL	RLD, RS	2014-02-28	`3a93d1ddd44b…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021812-001	6946120	2019-04-20	U-702	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021812-002	6946120	2019-04-20	U-702	Drug product	2015-01-21	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021812-001	6946120	2019-04-20	U-702	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021812-002	6946120	2019-04-20	U-702	Drug product	2015-01-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021812-001	6946120	2019-04-20	U-702	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021812-002	6946120	2019-04-20	U-702	Drug product	2015-01-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021812-001	6946120	2019-04-20	U-702	Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021812-002	6946120	2019-04-20	U-702	Drug product	2015-01-21	`ea99ee380514…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Womens Rogaine Unscented	MINOXIDIL	Kenvue Brands LLC	4d328537-b7f5-43cc-9837-c5a0c6c390f8	2024-11-13	Warnings	Exact identifier application applno (NDA): 021812 application number: NDA021812 ndc (product): 69968-0030
Mens rogaine Minoxidil Unscented Formula	MINOXIDIL	Kenvue Brands LLC	1b5e2860-6855-4a65-8bbc-e064172a1adf	2024-11-11	Warnings	Exact identifier application applno (NDA): 021812 application number: NDA021812 ndc (product): 69968-0031

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69968-0030	Womens Rogaine Unscented	Minoxidil	Johnson & Johnson Consumer Inc.	NDA	Current
69968-0030	Womens Rogaine Unscented	Minoxidil	Johnson & Johnson Consumer Inc.	NDA	Current
69968-0030	Womens Rogaine Unscented	Minoxidil	Johnson & Johnson Consumer Inc.	NDA	Current
69968-0030	Womens Rogaine Unscented	Minoxidil	Johnson & Johnson Consumer Inc.	NDA	Current
69968-0030	Womens Rogaine Unscented	Minoxidil	Johnson & Johnson Consumer Inc.	NDA	Current
69968-0031	Mens rogaine Minoxidil	Minoxidil	Johnson & Johnson Consumer Inc.	NDA	Current
69968-0031	Mens rogaine Minoxidil	Minoxidil	Johnson & Johnson Consumer Inc.	NDA	Current
69968-0031	Mens rogaine Minoxidil	Minoxidil	Johnson & Johnson Consumer Inc.	NDA	Current
69968-0031	Mens rogaine Minoxidil	Minoxidil	Johnson & Johnson Consumer Inc.	NDA	Current
69968-0031	Mens rogaine Minoxidil	Minoxidil	Johnson & Johnson Consumer Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84764	SUPPL	2026-01-15
84763	SUPPL	2026-01-15
65837	SUPPL	2021-01-07
65780	SUPPL	2020-12-30
61766	SUPPL	2020-02-04
61764	SUPPL	2020-02-04
59096	SUPPL	2019-06-17
59016	SUPPL	2019-06-12
16410	SUPPL	2015-02-17
28638	SUPPL	2015-02-12
16409	SUPPL	2014-03-27
6235	SUPPL	2014-03-04
37688	SUPPL	2014-01-13
28637	SUPPL	2013-12-17
21825	ORIG	2008-05-06
6234	SUPPL	2006-05-24
28636	ORIG	2006-01-30
37687	ORIG	2006-01-27