Home NDC 69968-0031 Mens rogaine Minoxidil
Product NDC 69968-0031
11-digit product format 699680031
Labeler code 69968
Product ID 69968-0031_2163626e-0033-3de8-e063-6294a90a9cfd
Type HUMAN OTC DRUG
Nonproprietary name Minoxidil
Dosage form AEROSOL, FOAM
Route TOPICAL
Labeler Kenvue Brands LLC
Application NDA021812
Marketing category NDA
Marketing start 2010-10-01
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 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 1 of 3 · 86 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N021812-001 MEN'S ROGAINE 5% AEROSOL, FOAM / TOPICAL RLD, RS 2006-01-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021812-002 WOMEN'S ROGAINE 5% AEROSOL, FOAM / TOPICAL RLD, RS 2014-02-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021812-001 MEN'S ROGAINE 5% AEROSOL, FOAM / TOPICAL RLD, RS 2006-01-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021812-002 WOMEN'S ROGAINE 5% AEROSOL, FOAM / TOPICAL RLD, RS 2014-02-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021812-001 MEN'S ROGAINE 5% AEROSOL, FOAM / TOPICAL RLD, RS 2006-01-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021812-002 WOMEN'S ROGAINE 5% AEROSOL, FOAM / TOPICAL RLD, RS 2014-02-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021812-001 MEN'S ROGAINE 5% AEROSOL, FOAM / TOPICAL RLD, RS 2006-01-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021812-002 WOMEN'S ROGAINE 5% AEROSOL, FOAM / TOPICAL RLD, RS 2014-02-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021812-001 MEN'S ROGAINE 5% AEROSOL, FOAM / TOPICAL RLD, RS 2006-01-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021812-002 WOMEN'S ROGAINE 5% AEROSOL, FOAM / TOPICAL RLD, RS 2014-02-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021812-001 MEN'S ROGAINE 5% AEROSOL, FOAM / TOPICAL RLD, RS 2006-01-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021812-002 WOMEN'S ROGAINE 5% AEROSOL, FOAM / TOPICAL RLD, RS 2014-02-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021812-001 MEN'S ROGAINE 5% AEROSOL, FOAM / TOPICAL RLD, RS 2006-01-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021812-002 WOMEN'S ROGAINE 5% AEROSOL, FOAM / TOPICAL RLD, RS 2014-02-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021812-001 MEN'S ROGAINE 5% AEROSOL, FOAM / TOPICAL RLD, RS 2006-01-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021812-002 WOMEN'S ROGAINE 5% AEROSOL, FOAM / TOPICAL RLD, RS 2014-02-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021812-001 MEN'S ROGAINE 5% AEROSOL, FOAM / TOPICAL RLD, RS 2006-01-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021812-002 WOMEN'S ROGAINE 5% AEROSOL, FOAM / TOPICAL RLD, RS 2014-02-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021812-001 MEN'S ROGAINE 5% AEROSOL, FOAM / TOPICAL RLD, RS 2006-01-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021812-002 WOMEN'S ROGAINE 5% AEROSOL, FOAM / TOPICAL RLD, RS 2014-02-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021812-001 MEN'S ROGAINE 5% AEROSOL, FOAM / TOPICAL RLD, RS 2006-01-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021812-002 WOMEN'S ROGAINE 5% AEROSOL, FOAM / TOPICAL RLD, RS 2014-02-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021812-001 MEN'S ROGAINE 5% AEROSOL, FOAM / TOPICAL RLD, RS 2006-01-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021812-002 WOMEN'S ROGAINE 5% AEROSOL, FOAM / TOPICAL RLD, RS 2014-02-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021812-001 MEN'S ROGAINE 5% AEROSOL, FOAM / TOPICAL RLD, RS 2006-01-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021812-002 WOMEN'S ROGAINE 5% AEROSOL, FOAM / TOPICAL RLD, RS 2014-02-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021812-001 MEN'S ROGAINE 5% AEROSOL, FOAM / TOPICAL RLD, RS 2006-01-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021812-002 WOMEN'S ROGAINE 5% AEROSOL, FOAM / TOPICAL RLD, RS 2014-02-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021812-001 MEN'S ROGAINE 5% AEROSOL, FOAM / TOPICAL RLD, RS 2006-01-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021812-002 WOMEN'S ROGAINE 5% AEROSOL, FOAM / TOPICAL RLD, RS 2014-02-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021812-001 MEN'S ROGAINE 5% AEROSOL, FOAM / TOPICAL RLD, RS 2006-01-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021812-002 WOMEN'S ROGAINE 5% AEROSOL, FOAM / TOPICAL RLD, RS 2014-02-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021812-001 MEN'S ROGAINE 5% AEROSOL, FOAM / TOPICAL RLD, RS 2006-01-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021812-002 WOMEN'S ROGAINE 5% AEROSOL, FOAM / TOPICAL RLD, RS 2014-02-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021812-001 MEN'S ROGAINE 5% AEROSOL, FOAM / TOPICAL RLD, RS 2006-01-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021812-002 WOMEN'S ROGAINE 5% AEROSOL, FOAM / TOPICAL RLD, RS 2014-02-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021812-001 MEN'S ROGAINE 5% AEROSOL, FOAM / TOPICAL RLD, RS 2006-01-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021812-002 WOMEN'S ROGAINE 5% AEROSOL, FOAM / TOPICAL RLD, RS 2014-02-28 4b0b4de00fa7…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…
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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Mens rogaine Minoxidil
Brand name suffix Unscented Formula
Listing expiration 2026-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 645146 Internal RxNorm lookup 702354 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69968-0031-1 Mens rogaine Minoxidil - Unscented Formula 1 in 1 PACKAGE AEROSOL, FOAM 1 7 69968-0031-1 Mens rogaine Minoxidil - Unscented Formula 60 g in 1 CAN AEROSOL, FOAM 60 7 69968-0031-3 Mens rogaine Minoxidil - Unscented Formula 60 g in 1 CAN AEROSOL, FOAM 60 7 69968-0031-3 Mens rogaine Minoxidil - Unscented Formula 3 in 1 PACKAGE AEROSOL, FOAM 3 7 69968-0031-4 Mens rogaine Minoxidil - Unscented Formula 4 in 1 PACKAGE AEROSOL, FOAM 4 7 69968-0031-4 Mens rogaine Minoxidil - Unscented Formula 60 g in 1 CAN AEROSOL, FOAM 60 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69968-0031 MENS ROGAINE MINOXIDIL - UNSCENTED FORMULA (MINOXIDIL) AEROSOL, FOAM [KENVUE BRANDS LLC] 7 Current NDC, Legacy NDC, 6 package rows 20241114_1b5e2860-6855-4a65-8bbc-e064172a1adf.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69968-0031-1 69968003101 1 CAN in 1 PACKAGE (69968-0031-1) / 60 g in 1 CAN 1 can 2010-10-01 0000-00-00 No No Current 69968-0031-3 69968003103 3 CAN in 1 PACKAGE (69968-0031-3) / 60 g in 1 CAN 3 can 2010-10-01 0000-00-00 No No Current 69968-0031-4 69968003104 4 CAN in 1 PACKAGE (69968-0031-4) / 60 g in 1 CAN 4 can 2010-10-01 0000-00-00 No No Current