MINOXIDIL FOR MEN

Product NDC
70000-0754
11-digit product format
700000754
Labeler code
70000
Product ID
70000-0754_a592317d-bc7c-4c69-a3bf-74d57cd36e3a
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 MEN
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
a592317d-bc7c-4c69-a3bf-74d57cd36e3aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0754-1MINOXIDIL FOR MEN60 g in 1 CANAEROSOL, FOAM601
70000-0754-1MINOXIDIL FOR MEN3 in 1 CARTONAEROSOL, FOAM31

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
MINOXIDIL FOR MENMINOXIDILCARDINAL HEALTH 110, LLC. DBA LEADERa592317d-bc7c-4c69-a3bf-74d57cd36e3a2026-04-13WarningsExact identifier
application applno (ANDA): 218616
application number: ANDA218616
ndc (product): 70000-0754
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 FoamPSNa592317d-bc7c-4c69-a3bf-74d57cd36e3a1
645146minoxidil 50 MG/ML Topical FoamSCDa592317d-bc7c-4c69-a3bf-74d57cd36e3a1
645146minoxidil 5 % Topical FoamSYa592317d-bc7c-4c69-a3bf-74d57cd36e3a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70000-0754-1700000754013 CAN in 1 CARTON (70000-0754-1) / 60 g in 1 CAN3 can2026-03-16NoNoCurrent