Womens Rogaine Unscented

Product NDC
69968-0090
Requested package NDC
69968-0090-1
11-digit product format
699680090
Labeler code
69968
Product ID
69968-0090_216dc8a4-5da7-7a49-e063-6294a90a6333
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Kenvue Brands LLC
Application
NDA019501
Marketing category
NDA
Marketing start
2010-08-01
Substance
MINOXIDIL
Active strength
20 mg/mL
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
N019501-002ROGAINE (FOR MEN)MINOXIDIL2%SOLUTION / TOPICALRLD, RS1996-02-09
N019501-003ROGAINE (FOR WOMEN)MINOXIDIL2%SOLUTION / TOPICALRLD, RS1996-02-09

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 22:38:342026-08N019501-002ROGAINE (FOR MEN)2%SOLUTION / TOPICALRLD, RS1996-02-0984e616aacf4f…
2026-09-14 22:38:342026-08N019501-003ROGAINE (FOR WOMEN)2%SOLUTION / TOPICALRLD, RS1996-02-0984e616aacf4f…
2026-08-18 06:07:402026-07N019501-002ROGAINE (FOR MEN)2%SOLUTION / TOPICALRLD, RS1996-02-09caaa826d4ba7…
2026-08-18 06:07:402026-07N019501-003ROGAINE (FOR WOMEN)2%SOLUTION / TOPICALRLD, RS1996-02-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019501-002ROGAINE (FOR MEN)2%SOLUTION / TOPICALRLD, RS1996-02-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019501-003ROGAINE (FOR WOMEN)2%SOLUTION / TOPICALRLD, RS1996-02-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019501-002ROGAINE (FOR MEN)2%SOLUTION / TOPICALRLD, RS1996-02-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019501-003ROGAINE (FOR WOMEN)2%SOLUTION / TOPICALRLD, RS1996-02-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N019501-002ROGAINE (FOR MEN)2%SOLUTION / TOPICALRLD, RS1996-02-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019501-003ROGAINE (FOR WOMEN)2%SOLUTION / TOPICALRLD, RS1996-02-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019501-002ROGAINE (FOR MEN)2%SOLUTION / TOPICALRLD, RS1996-02-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019501-003ROGAINE (FOR WOMEN)2%SOLUTION / TOPICALRLD, RS1996-02-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019501-002ROGAINE (FOR MEN)2%SOLUTION / TOPICALRLD, RS1996-02-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019501-003ROGAINE (FOR WOMEN)2%SOLUTION / TOPICALRLD, RS1996-02-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019501-002ROGAINE (FOR MEN)2%SOLUTION / TOPICALRLD, RS1996-02-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019501-003ROGAINE (FOR WOMEN)2%SOLUTION / TOPICALRLD, RS1996-02-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019501-002ROGAINE (FOR MEN)2%SOLUTION / TOPICALRLD, RS1996-02-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019501-003ROGAINE (FOR WOMEN)2%SOLUTION / TOPICALRLD, RS1996-02-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019501-002ROGAINE (FOR MEN)2%SOLUTION / TOPICALRLD, RS1996-02-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019501-003ROGAINE (FOR WOMEN)2%SOLUTION / TOPICALRLD, RS1996-02-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019501-002ROGAINE (FOR MEN)2%SOLUTION / TOPICALRLD, RS1996-02-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019501-003ROGAINE (FOR WOMEN)2%SOLUTION / TOPICALRLD, RS1996-02-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019501-002ROGAINE (FOR MEN)2%SOLUTION / TOPICALRLD, RS1996-02-09d06236e962d9…
2024-10-29 15:01 UTC2024-10N019501-003ROGAINE (FOR WOMEN)2%SOLUTION / TOPICALRLD, RS1996-02-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019501-002ROGAINE (FOR MEN)2%SOLUTION / TOPICALRLD, RS1996-02-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019501-003ROGAINE (FOR WOMEN)2%SOLUTION / TOPICALRLD, RS1996-02-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019501-002ROGAINE (FOR MEN)2%SOLUTION / TOPICALRLD, RS1996-02-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019501-003ROGAINE (FOR WOMEN)2%SOLUTION / TOPICALRLD, RS1996-02-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019501-002ROGAINE (FOR MEN)2%SOLUTION / TOPICALRLD, RS1996-02-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019501-003ROGAINE (FOR WOMEN)2%SOLUTION / TOPICALRLD, RS1996-02-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019501-002ROGAINE (FOR MEN)2%SOLUTION / TOPICALRLD, RS1996-02-098072bd15b7f6…
2024-05-31 18:47 UTC2024-05N019501-003ROGAINE (FOR WOMEN)2%SOLUTION / TOPICALRLD, RS1996-02-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019501-002ROGAINE (FOR MEN)2%SOLUTION / TOPICALRLD, RS1996-02-095c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019501-003ROGAINE (FOR WOMEN)2%SOLUTION / TOPICALRLD, RS1996-02-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019501-002ROGAINE (FOR MEN)2%SOLUTION / TOPICALRLD, RS1996-02-095d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N019501-003ROGAINE (FOR WOMEN)2%SOLUTION / TOPICALRLD, RS1996-02-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019501-002ROGAINE (FOR MEN)2%SOLUTION / TOPICALRLD, RS1996-02-094b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N019501-003ROGAINE (FOR WOMEN)2%SOLUTION / TOPICALRLD, RS1996-02-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019501-002ROGAINE (FOR MEN)2%SOLUTION / TOPICALRLD, RS1996-02-0974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019501-003ROGAINE (FOR WOMEN)2%SOLUTION / TOPICALRLD, RS1996-02-0974a2ff9319b5…

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
MINOXIDIL20 mg/mL

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
207371Internal RxNorm lookup
311723Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8bf0000c-95f3-4a4d-830b-f5ac1539823dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0090-1Womens Rogaine Unscented60 mL in 1 BOTTLE, PLASTICSOLUTION604
69968-0090-1Womens Rogaine Unscented1 in 1 CARTONSOLUTION14
69968-0090-3Womens Rogaine Unscented60 mL in 1 BOTTLE, PLASTICSOLUTION604
69968-0090-3Womens Rogaine Unscented3 in 1 CARTONSOLUTION34

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69968-0090-1ML - Milliliter69968-0090a5e401b8-58a9-43dd-96b6-d35d6891325512022-06-06
69968-0090-3ML - Milliliter69968-0090b39d56a1-38a0-4c87-882b-2daf8f30996d12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0090WOMENS ROGAINE UNSCENTED (MINOXIDIL) SOLUTION [KENVUE BRANDS LLC]4Current NDC, Legacy NDC, 4 package rows20241102_8bf0000c-95f3-4a4d-830b-f5ac1539823d.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Womens Rogaine UnscentedMINOXIDILKenvue Brands LLC8bf0000c-95f3-4a4d-830b-f5ac1539823d2024-09-06WarningsExact identifier
application applno (NDA): 019501
application number: NDA019501
ndc (package): 69968-0090-1
ndc (product): 69968-0090
ndc11 (package): 69968009001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311723minoxidil 2 % Topical SolutionPSN8bf0000c-95f3-4a4d-830b-f5ac1539823d4
207371Rogaine Women's 2 % Topical SolutionPSN8bf0000c-95f3-4a4d-830b-f5ac1539823d4
207371minoxidil 20 MG/ML Topical Solution [Rogaine]SBD8bf0000c-95f3-4a4d-830b-f5ac1539823d4
311723minoxidil 20 MG/ML Topical SolutionSCD8bf0000c-95f3-4a4d-830b-f5ac1539823d4
311723minoxidil 2 % Topical SolutionSY8bf0000c-95f3-4a4d-830b-f5ac1539823d4
311723minoxidil 2 GM per 100 ML Topical SolutionSY8bf0000c-95f3-4a4d-830b-f5ac1539823d4
207371Rogaine 2 % Topical SolutionSY8bf0000c-95f3-4a4d-830b-f5ac1539823d4
207371Rogaine 20 MG/ML Topical SolutionSY8bf0000c-95f3-4a4d-830b-f5ac1539823d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69968-0090-1699680090011 BOTTLE, PLASTIC in 1 CARTON (69968-0090-1) / 60 mL in 1 BOTTLE, PLASTIC2010-08-010000-00-00NoNoCurrent