Minoxidil For Women

Product NDC
69113-502
Requested package NDC
69113-502-01
11-digit product format
691130502
Labeler code
69113
Product ID
69113-502_0e642b3c-98d8-4262-befb-f7df47661ca8
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
BosleyMD
Application
ANDA208092
Marketing category
ANDA
Marketing start
2025-08-29
Substance
MINOXIDIL
Active strength
50 mg/g
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
A208092-001MINOXIDIL (FOR MEN)MINOXIDIL5%AEROSOL, FOAM / TOPICAL2017-02-17
A208092-002MINOXIDIL (FOR WOMEN)MINOXIDIL5%AEROSOL, FOAM / TOPICAL2017-07-27

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-1784e616aacf4f…
2026-09-14 22:38:342026-08A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-2784e616aacf4f…
2026-08-18 06:07:402026-07A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-17caaa826d4ba7…
2026-08-18 06:07:402026-07A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-1774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-2774a2ff9319b5…

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
Minoxidil For Women
Listing expiration
2027-12-31

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ebda6e49-140c-4ab0-b155-5ed501ef3e8aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69113-502-01Minoxidil For Women1 in 1 PACKAGEAEROSOL, FOAM15
69113-502-01Minoxidil For Women60 g in 1 CANAEROSOL, FOAM605
69113-502-02Minoxidil For Women2 in 1 PACKAGEAEROSOL, FOAM25
69113-502-02Minoxidil For Women60 g in 1 CANAEROSOL, FOAM605

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MinoxidilMINOXIDILKeranique4af782f4-68d5-4338-a0a6-85d11a23ce982026-08-18WarningsExact identifier
application applno (ANDA): 208092
application number: ANDA208092
MinoxidilMINOXIDILP & L Development, LLC869ce741-3094-4123-9059-0669f3591b2f2026-08-06WarningsExact identifier
application applno (ANDA): 208092
application number: ANDA208092
Minoxidil For WomenMINOXIDILBosleyMDebda6e49-140c-4ab0-b155-5ed501ef3e8a2026-03-24WarningsExact identifier
application applno (ANDA): 208092
application number: ANDA208092
ndc (package): 69113-502-01
ndc (product): 69113-502
ndc11 (package): 69113050201
Minoxidil For MenMINOXIDILBosleyMD61c41686-81af-4000-94bc-3cf9e71b0f182026-03-24WarningsExact identifier
application applno (ANDA): 208092
application number: ANDA208092
MinoxidilMINOXIDILP & L Development, LLC204bab15-47c5-449c-a889-700914b04b612026-03-03WarningsExact identifier
application applno (ANDA): 208092
application number: ANDA208092
MinoxidilMINOXIDILP & L Development, LLC04373c29-85f3-4d7d-bbdd-950dcf1a879a2026-03-03WarningsExact identifier
application applno (ANDA): 208092
application number: ANDA208092
MinoxidilMINOXIDILP & L Development, LLC59e7cdae-6595-4aa2-8fe0-7a8bcf3009122024-11-05WarningsExact identifier
application applno (ANDA): 208092
application number: ANDA208092
MinoxidilMINOXIDILP & L Development, LLC73dc7e7f-92c2-4ab2-a260-ceb198e591cf2024-11-05WarningsExact identifier
application applno (ANDA): 208092
application number: ANDA208092

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
645146minoxidil 5 % Topical FoamPSNebda6e49-140c-4ab0-b155-5ed501ef3e8a5
645146minoxidil 50 MG/ML Topical FoamSCDebda6e49-140c-4ab0-b155-5ed501ef3e8a5
645146minoxidil 5 % Topical FoamSYebda6e49-140c-4ab0-b155-5ed501ef3e8a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69113-502-01691130502011 CAN in 1 PACKAGE (69113-502-01) / 60 g in 1 CAN1 can2025-08-29NoNoCurrent