MINOXIDIL 5% (FOR WOMEN)

Product NDC
58602-607
11-digit product format
586020607
Labeler code
58602
Product ID
58602-607_510be93d-eede-433e-a647-2f26f47cddc5
Type
HUMAN OTC DRUG
Nonproprietary name
MINOXIDIL
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Aurohealth LLC
Application
ANDA218616
Marketing category
ANDA
Marketing start
2024-04-22
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 42.

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
A218616-001MINOXIDIL (FOR MEN)MINOXIDIL5%AEROSOL, FOAM / TOPICAL2024-04-22
A218616-002MINOXIDIL (FOR WOMEN)MINOXIDIL5%AEROSOL, FOAM / TOPICAL2024-04-22

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A218616-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2024-04-22caaa826d4ba7…
2026-08-18 06:07:402026-07A218616-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2024-04-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218616-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2024-04-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218616-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2024-04-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218616-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2024-04-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218616-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2024-04-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A218616-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2024-04-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218616-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2024-04-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218616-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2024-04-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218616-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2024-04-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218616-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2024-04-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218616-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2024-04-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218616-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2024-04-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218616-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2024-04-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218616-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2024-04-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218616-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2024-04-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218616-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2024-04-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218616-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2024-04-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218616-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2024-04-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218616-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2024-04-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A218616-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2024-04-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A218616-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2024-04-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218616-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2024-04-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218616-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2024-04-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A218616-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2024-04-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A218616-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2024-04-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A218616-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2024-04-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A218616-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2024-04-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A218616-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2024-04-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05A218616-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2024-04-228072bd15b7f6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218616-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2024-04-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218616-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2024-04-22a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
MINOXIDIL 5% (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
dbda95f2-11a8-4b2f-af45-b791342fff70Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-607-01MINOXIDIL 5% (FOR WOMEN)1 in 1 CARTONAEROSOL, FOAM14
58602-607-01MINOXIDIL 5% (FOR WOMEN)60 g in 1 CANAEROSOL, FOAM604
58602-607-02MINOXIDIL 5% (FOR WOMEN)2 in 1 CARTONAEROSOL, FOAM24
58602-607-02MINOXIDIL 5% (FOR WOMEN)60 g in 1 CANAEROSOL, FOAM604
58602-607-03MINOXIDIL 5% (FOR WOMEN)60 g in 1 CANAEROSOL, FOAM604
58602-607-03MINOXIDIL 5% (FOR WOMEN)3 in 1 CARTONAEROSOL, FOAM34
58602-607-04MINOXIDIL 5% (FOR WOMEN)4 in 1 CARTONAEROSOL, FOAM44
58602-607-04MINOXIDIL 5% (FOR WOMEN)60 g in 1 CANAEROSOL, FOAM604
58602-607-05MINOXIDIL 5% (FOR WOMEN)6 in 1 CARTONAEROSOL, FOAM64
58602-607-05MINOXIDIL 5% (FOR WOMEN)60 g in 1 CANAEROSOL, FOAM604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-607MINOXIDIL 5% (FOR WOMEN) (MINOXIDIL) AEROSOL, FOAM [AUROHEALTH LLC]1Current NDC, 10 package rows20240504_dbda95f2-11a8-4b2f-af45-b791342fff70.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MINOXIDIL (FOR MEN)MINOXIDILFlexiGo Inc5406743a-b688-346e-e063-6294a90a2caf2026-06-11WarningsExact identifier
application applno (ANDA): 218616
application number: ANDA218616
MINOXIDIL (FOR MEN)MINOXIDILFlexiGo Inc53793182-8a03-1b0f-e063-6294a90acca62026-06-04WarningsExact identifier
application applno (ANDA): 218616
application number: ANDA218616
MINOXIDIL FOR WOMENMINOXIDILCARDINAL HEALTH 110, LLC. DBA LEADER33f9e0de-dff1-4a14-8aec-8c842bf34c312026-04-13WarningsExact identifier
application applno (ANDA): 218616
application number: ANDA218616
MINOXIDIL FOR MENMINOXIDILCARDINAL HEALTH 110, LLC. DBA LEADERa592317d-bc7c-4c69-a3bf-74d57cd36e3a2026-04-13WarningsExact identifier
application applno (ANDA): 218616
application number: ANDA218616
Nizoral Hair Regrowth Treatment for MenMINOXIDILKramer Laboratoriesd3260777-d56a-4a35-ac82-b0e8e80215172026-03-04WarningsExact identifier
application applno (ANDA): 218616
application number: ANDA218616
MINOXIDIL 5% (FOR WOMEN)MINOXIDILAurohealth LLCdbda95f2-11a8-4b2f-af45-b791342fff702026-01-22WarningsExact identifier
application applno (ANDA): 218616
application number: ANDA218616
ndc (product): 58602-607
MINOXIDIL 5% (FOR MEN)MINOXIDILAurohealth LLCe6b3b997-cde9-476d-b08c-4d1010456d8b2026-01-22WarningsExact identifier
application applno (ANDA): 218616
application number: ANDA218616
REGOXIDINE (FOR WOMEN)MINOXIDILINNOVUS PHARMACEUTICALS, INC.9c06c34d-5a09-47ed-b969-cc81f4ed61ab2026-01-20WarningsExact identifier
application applno (ANDA): 218616
application number: ANDA218616
REGOXIDINE (FOR MEN)MINOXIDILINNOVUS PHARMACEUTICALS, INC.d191b3a9-0fb7-45cc-82a1-b64a79c0c1252026-01-20WarningsExact identifier
application applno (ANDA): 218616
application number: ANDA218616

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
645146minoxidil 5 % Topical FoamPSNdbda95f2-11a8-4b2f-af45-b791342fff704
645146minoxidil 50 MG/ML Topical FoamSCDdbda95f2-11a8-4b2f-af45-b791342fff704
645146minoxidil 5 % Topical FoamSYdbda95f2-11a8-4b2f-af45-b791342fff704

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58602-607-01586020607011 CAN in 1 CARTON (58602-607-01) / 60 g in 1 CAN1 can2024-04-22NoNoCurrent
58602-607-02586020607022 CAN in 1 CARTON (58602-607-02) / 60 g in 1 CAN2 can2024-04-22NoNoCurrent
58602-607-03586020607033 CAN in 1 CARTON (58602-607-03) / 60 g in 1 CAN3 can2024-04-22NoNoCurrent
58602-607-04586020607044 CAN in 1 CARTON (58602-607-04) / 60 g in 1 CAN4 can2024-04-22NoNoCurrent
58602-607-05586020607056 CAN in 1 CARTON (58602-607-05) / 60 g in 1 CAN6 can2024-04-22NoNoCurrent