Minoxidil

Product NDC
69113-128
11-digit product format
691130128
Labeler code
69113
Product ID
69113-128_1c5ccd0b-f7f2-89c9-e063-6294a90a43de
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
SCIENTIFIC HAIR RESEARCH, LLC
Application
ANDA209074
Marketing category
ANDA
Marketing start
2020-12-23
Substance
MINOXIDIL
Active strength
50 mg/g
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 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
A209074-001MINOXIDIL (FOR MEN)MINOXIDIL5%AEROSOL, FOAM / TOPICAL2018-12-31
A209074-002MINOXIDIL (FOR WOMEN)MINOXIDIL5%AEROSOL, FOAM / TOPICAL2019-04-22

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.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-31caaa826d4ba7…
2026-08-18 06:07:402026-07A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-22bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
Minoxidil
Brand name suffix
(for Men)
Listing expiration
2026-12-31

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
5b8fe2d9-c7c5-4563-82f2-3d6bff08b830Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69113-128-01Minoxidil (for Men)1 in 1 PACKAGEAEROSOL, FOAM12
69113-128-01Minoxidil (for Men)60 g in 1 CANAEROSOL, FOAM602
69113-128-03Minoxidil (for Men)60 g in 1 CANAEROSOL, FOAM602
69113-128-03Minoxidil (for Men)3 in 1 PACKAGEAEROSOL, FOAM32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69113-128MINOXIDIL (FOR MEN) (MINOXIDIL) AEROSOL, FOAM [SCIENTIFIC HAIR RESEARCH, LLC]2Current NDC, Legacy NDC, 4 package rows20240704_5b8fe2d9-c7c5-4563-82f2-3d6bff08b830.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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MinoxidilMINOXIDIL FOAM 5% (WOMENS)Clarity Cosmetics Inc.1b54eca8-4a96-1b5e-e063-6394a90a7b942026-05-08WarningsExact identifier
application applno (ANDA): 209074
application number: ANDA209074
Minoxidil (For Women)MINOXIDILCVS Pharmacyb10eb8fd-8301-4c38-af4c-220fe5c3b5922026-04-06WarningsExact identifier
application applno (ANDA): 209074
application number: ANDA209074
Minoxidil (For Men)MINOXIDILCVS Pharmacyf6d90382-dc51-480c-a46c-bad041915d072026-04-06WarningsExact identifier
application applno (ANDA): 209074
application number: ANDA209074
Minoxidil 5% (For Men)MINOXIDILSun Pharmaceutical Industries, Inc.52210e2d-d87c-4b53-9b58-95c65c9d11fa2026-03-10WarningsExact identifier
application applno (ANDA): 209074
application number: ANDA209074
Minoxidil For WomenMINOXIDILSun Pharmaceutical Industries, Inc.82d7a480-46b2-423b-8da0-a4fc252f77472026-03-10WarningsExact identifier
application applno (ANDA): 209074
application number: ANDA209074
Gemachlich ZuHause Hair Growth Foam (Men)HAIR GROWTH FOAM (MEN)Guangdong Quadrant Ecological Technology Co., Ltd.3abe6f17-17ed-e25c-e063-6294a90a4d4d2025-07-25WarningsExact identifier
application applno (ANDA): 209074
application number: ANDA209074
Minoxidil (for Women)MINOXIDILVirtue Labs, LLC85a9d343-1135-4296-96b5-fabab6b834f92025-07-17WarningsExact identifier
application applno (ANDA): 209074
application number: ANDA209074
Minoxidil (for Men)MINOXIDILRESTORATION HOLDINGS, LLCe18223ad-642e-81a5-e053-2a95a90a07522024-12-11WarningsExact identifier
application applno (ANDA): 209074
application number: ANDA209074
Minoxidil (for Women)MINOXIDILSCIENTIFIC HAIR RESEARCH, LLC19603dd4-2099-479d-9e6e-14c5d1c499282024-07-03WarningsExact identifier
application applno (ANDA): 209074
application number: ANDA209074
Minoxidil (for Men)MINOXIDILSCIENTIFIC HAIR RESEARCH, LLC5b8fe2d9-c7c5-4563-82f2-3d6bff08b8302024-07-03WarningsExact identifier
application applno (ANDA): 209074
application number: ANDA209074
ndc (product): 69113-128
Minoxidil (For Men)MINOXIDILTARGET Corporation5505e1b2-8c9b-457c-8291-cb8a9c1f6b102024-05-17WarningsExact identifier
application applno (ANDA): 209074
application number: ANDA209074
Minoxidil (For Women)MINOXIDILTARGET Corporation3a6bef39-1d8e-4ce3-9484-becd294566da2024-04-16WarningsExact identifier
application applno (ANDA): 209074
application number: ANDA209074
Minoxidil (For Men)MINOXIDILSPAZI INC.2b6abc4d-3596-4411-a9f8-77c338c99a5d2024-01-23WarningsExact identifier
application applno (ANDA): 209074
application number: ANDA209074
Minoxidil (For Women)MINOXIDILSPAZI INC.facdb1c2-c36e-4bcc-a821-f8bad8bb17aa2024-01-23WarningsExact identifier
application applno (ANDA): 209074
application number: ANDA209074
Regoxidine (For Men)MINOXIDILInnovus Pharmaceuticals, Inc.43b58fd3-81a7-4e64-81f3-9d9acfbf68192022-12-16WarningsExact identifier
application applno (ANDA): 209074
application number: ANDA209074
Regoxidine (For Women)MINOXIDILInnovus Pharmaceuticals, Inc.b60cc177-700c-4007-be1a-2cb74824e6572022-12-16WarningsExact identifier
application applno (ANDA): 209074
application number: ANDA209074
Minoxidil (For Women)MINOXIDILKroger Companyc443fadd-669e-4d29-8b11-ef3c022ca6f42022-10-25WarningsExact identifier
application applno (ANDA): 209074
application number: ANDA209074
Minoxidil 5% (For Men)MINOXIDILKroger Company8346788b-88b3-45c6-8c27-b34a810154fb2022-10-24WarningsExact identifier
application applno (ANDA): 209074
application number: ANDA209074
Minoxidil (For Men)MINOXIDILWalgreen Company39526f7d-5e39-4e2e-8689-94b76ddbc4622022-10-10WarningsExact identifier
application applno (ANDA): 209074
application number: ANDA209074
Minoxidil (For Women)MINOXIDILWalgreen Company8a32828d-1591-478d-aed3-5159232675b42022-10-10WarningsExact identifier
application applno (ANDA): 209074
application number: ANDA209074

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
645146minoxidil 5 % Topical FoamPSN5b8fe2d9-c7c5-4563-82f2-3d6bff08b8302
645146minoxidil 50 MG/ML Topical FoamSCD5b8fe2d9-c7c5-4563-82f2-3d6bff08b8302
645146minoxidil 5 % Topical FoamSY5b8fe2d9-c7c5-4563-82f2-3d6bff08b8302

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69113-128-01691130128011 CAN in 1 PACKAGE (69113-128-01) / 60 g in 1 CAN1 can2020-12-230000-00-00NoNoCurrent
69113-128-03691130128033 CAN in 1 PACKAGE (69113-128-03) / 60 g in 1 CAN3 can2020-12-230000-00-00NoNoCurrent