Womens Rogaine Unscented

Product NDC
69968-0030
Requested package NDC
69968-0030-3
11-digit product format
699680030
Labeler code
69968
Product ID
69968-0030_2160c309-2fc9-b8c7-e063-6294a90ae132
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Kenvue Brands LLC
Application
NDA021812
Marketing category
NDA
Marketing start
2011-04-01
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021812-001MEN'S ROGAINEMINOXIDIL5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-20
N021812-002WOMEN'S ROGAINEMINOXIDIL5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-28

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-2084e616aacf4f…
2026-09-14 22:38:342026-08N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-2884e616aacf4f…
2026-08-18 06:07:402026-07N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-20caaa826d4ba7…
2026-08-18 06:07:402026-07N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-20d06236e962d9…
2024-10-29 15:01 UTC2024-10N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-205c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-205d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-204b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-2874a2ff9319b5…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021812-00169461202019-04-20U-702Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021812-00269461202019-04-20U-702Drug product2015-01-2174a2ff9319b5…
2019-12-14 00:12 UTC2019-12N021812-00169461202019-04-20U-702Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021812-00269461202019-04-20U-702Drug product2015-01-213f01610625f2…
2019-09-15 20:21 UTC2019-09N021812-00169461202019-04-20U-702Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021812-00269461202019-04-20U-702Drug product2015-01-21b00525d2431f…
2019-07-19 19:46 UTC2019-07N021812-00169461202019-04-20U-702Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021812-00269461202019-04-20U-702Drug product2015-01-21ea99ee380514…

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
Womens Rogaine Unscented
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5965120SH1Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
645146Internal RxNorm lookup
702354Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4d328537-b7f5-43cc-9837-c5a0c6c390f8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0030-1Womens Rogaine Unscented1 in 1 CARTONAEROSOL, FOAM16
69968-0030-1Womens Rogaine Unscented60 g in 1 CANAEROSOL, FOAM606
69968-0030-2Womens Rogaine Unscented2 in 1 CARTONAEROSOL, FOAM26
69968-0030-2Womens Rogaine Unscented60 g in 1 CANAEROSOL, FOAM606
69968-0030-3Womens Rogaine Unscented60 g in 1 CANAEROSOL, FOAM606
69968-0030-3Womens Rogaine Unscented3 in 1 CARTONAEROSOL, FOAM36

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0030WOMENS ROGAINE UNSCENTED (MINOXIDIL) AEROSOL, FOAM [KENVUE BRANDS LLC]6Current NDC, Legacy NDC, 6 package rows20241115_4d328537-b7f5-43cc-9837-c5a0c6c390f8.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Womens Rogaine UnscentedMINOXIDILKenvue Brands LLC4d328537-b7f5-43cc-9837-c5a0c6c390f82024-11-13WarningsExact identifier
application applno (NDA): 021812
application number: NDA021812
ndc (package): 69968-0030-3
ndc (product): 69968-0030
ndc11 (package): 69968003003
Mens rogaine Minoxidil Unscented FormulaMINOXIDILKenvue Brands LLC1b5e2860-6855-4a65-8bbc-e064172a1adf2024-11-11WarningsExact identifier
application applno (NDA): 021812
application number: NDA021812

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
645146minoxidil 5 % Topical FoamPSN4d328537-b7f5-43cc-9837-c5a0c6c390f86
702354Rogaine 5 % Topical FoamPSN4d328537-b7f5-43cc-9837-c5a0c6c390f86
702354minoxidil 50 MG/ML Topical Foam [Rogaine]SBD4d328537-b7f5-43cc-9837-c5a0c6c390f86
645146minoxidil 50 MG/ML Topical FoamSCD4d328537-b7f5-43cc-9837-c5a0c6c390f86
645146minoxidil 5 % Topical FoamSY4d328537-b7f5-43cc-9837-c5a0c6c390f86
702354Rogaine 5 % Topical FoamSY4d328537-b7f5-43cc-9837-c5a0c6c390f86
702354Rogaine 50 MG/ML Topical FoamSY4d328537-b7f5-43cc-9837-c5a0c6c390f86

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69968-0030-3699680030033 CAN in 1 CARTON (69968-0030-3) / 60 g in 1 CAN3 can2011-04-010000-00-00NoNoCurrent