MINOXIDIL FOR WOMEN

Product NDC
70000-0753
11-digit product format
700000753
Labeler code
70000
Product ID
70000-0753_33f9e0de-dff1-4a14-8aec-8c842bf34c31
Type
HUMAN OTC DRUG
Nonproprietary name
MINOXIDIL
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
CARDINAL HEALTH 110, LLC. DBA LEADER
Application
ANDA218616
Marketing category
ANDA
Marketing start
2026-03-16
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
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
2026-09-14 22:38:342026-08A218616-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2024-04-2284e616aacf4f…
2026-09-14 22:38:342026-08A218616-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2024-04-2284e616aacf4f…
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…

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
33f9e0de-dff1-4a14-8aec-8c842bf34c31Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0753-1MINOXIDIL FOR WOMEN1 in 1 CARTONAEROSOL, FOAM11
70000-0753-1MINOXIDIL FOR WOMEN60 g in 1 CANAEROSOL, FOAM601

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 5% (FOR MEN)MINOXIDILBetter Living Brands, LLC53e33414-2aa4-3dbd-e063-6294a90a06b52026-08-27WarningsExact 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
ndc (product): 70000-0753
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
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 FoamPSN33f9e0de-dff1-4a14-8aec-8c842bf34c311
645146minoxidil 50 MG/ML Topical FoamSCD33f9e0de-dff1-4a14-8aec-8c842bf34c311
645146minoxidil 5 % Topical FoamSY33f9e0de-dff1-4a14-8aec-8c842bf34c311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70000-0753-1700000753011 CAN in 1 CARTON (70000-0753-1) / 60 g in 1 CAN1 can2026-03-16NoNoCurrent