Minoxidil

Product NDC
37808-202
Requested package NDC
37808-202-30
11-digit product format
378080202
Labeler code
37808
Product ID
37808-202_d2915eda-7964-475a-9a86-088b194eadb8
Type
HUMAN OTC DRUG
Nonproprietary name
minoxidil
Dosage form
SOLUTION
Route
TOPICAL
Labeler
H E B
Application
ANDA075357
Marketing category
ANDA
Marketing start
2011-04-04
Marketing end
0000-00-00
Substance
MINOXIDIL
Active strength
2 g/100mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage37808-20237808-202-30DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage37808-20237808-202-30DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37808-20237808-202-30DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A075357-001MINOXIDIL (FOR MEN)MINOXIDIL2%SOLUTION / TOPICAL1999-07-30
A075357-002MINOXIDIL (FOR WOMEN)MINOXIDIL2%SOLUTION / TOPICAL1999-07-30

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075357-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1999-07-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075357-002MINOXIDIL (FOR WOMEN)2%SOLUTION / TOPICAL1999-07-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075357-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1999-07-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075357-002MINOXIDIL (FOR WOMEN)2%SOLUTION / TOPICAL1999-07-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A075357-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1999-07-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075357-002MINOXIDIL (FOR WOMEN)2%SOLUTION / TOPICAL1999-07-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075357-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1999-07-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075357-002MINOXIDIL (FOR WOMEN)2%SOLUTION / TOPICAL1999-07-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075357-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1999-07-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075357-002MINOXIDIL (FOR WOMEN)2%SOLUTION / TOPICAL1999-07-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075357-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1999-07-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075357-002MINOXIDIL (FOR WOMEN)2%SOLUTION / TOPICAL1999-07-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075357-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1999-07-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075357-002MINOXIDIL (FOR WOMEN)2%SOLUTION / TOPICAL1999-07-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075357-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1999-07-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075357-002MINOXIDIL (FOR WOMEN)2%SOLUTION / TOPICAL1999-07-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075357-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1999-07-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075357-002MINOXIDIL (FOR WOMEN)2%SOLUTION / TOPICAL1999-07-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075357-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1999-07-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A075357-002MINOXIDIL (FOR WOMEN)2%SOLUTION / TOPICAL1999-07-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075357-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1999-07-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075357-002MINOXIDIL (FOR WOMEN)2%SOLUTION / TOPICAL1999-07-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075357-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1999-07-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075357-002MINOXIDIL (FOR WOMEN)2%SOLUTION / TOPICAL1999-07-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075357-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1999-07-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075357-002MINOXIDIL (FOR WOMEN)2%SOLUTION / TOPICAL1999-07-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075357-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1999-07-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075357-002MINOXIDIL (FOR WOMEN)2%SOLUTION / TOPICAL1999-07-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075357-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1999-07-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075357-002MINOXIDIL (FOR WOMEN)2%SOLUTION / TOPICAL1999-07-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075357-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1999-07-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075357-002MINOXIDIL (FOR WOMEN)2%SOLUTION / TOPICAL1999-07-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075357-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1999-07-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075357-002MINOXIDIL (FOR WOMEN)2%SOLUTION / TOPICAL1999-07-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075357-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1999-07-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075357-002MINOXIDIL (FOR WOMEN)2%SOLUTION / TOPICAL1999-07-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075357-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1999-07-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075357-002MINOXIDIL (FOR WOMEN)2%SOLUTION / TOPICAL1999-07-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075357-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1999-07-30782e0a99824c…
2021-12-28 21:50 UTC2021-12A075357-002MINOXIDIL (FOR WOMEN)2%SOLUTION / TOPICAL1999-07-30782e0a99824c…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINOXIDILACTIVE INGREDIENT5965120SH1MINOXIDIL SOLUTION [H E B]3
MINOXIDILACTIVE MOIETY5965120SH1MINOXIDIL SOLUTION [H E B]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MMINOXIDIL SOLUTION [H E B]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MINOXIDIL SOLUTION [H E B]3
WATERINACTIVE INGREDIENT059QF0KO0RMINOXIDIL SOLUTION [H E B]3

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 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
carols daughter hair regrowth treatmentMINOXIDILL'Oreal USA Products Inc.9701797c-76bb-44d4-b28a-2c15a4444b412026-06-23WarningsExact identifier
application applno (ANDA): 075357
application number: ANDA075357
equate hair regrowth treatmentMINOXIDILWALMART INC.fd67b4d2-e71d-4145-bf69-437d0aa86cd32026-05-12WarningsExact identifier
application applno (ANDA): 075357
application number: ANDA075357
hair regrowth treatmentMINOXIDILMeijer, Inc.5cb0fe8a-996f-4bcf-8282-845ad6c6d8192026-02-05WarningsExact identifier
application applno (ANDA): 075357
application number: ANDA075357
GOOD SENSE HAIR REGROWTH TREATMENTMINOXIDILL. Perrigo Companyb1bf381e-8f13-4a7e-a2f6-ba750d4d67e72025-10-27WarningsExact identifier
application applno (ANDA): 075357
application number: ANDA075357
minoxidilMINOXIDILPublix Super Markets Incd0ff44ef-d59c-43c9-a381-448fef2cfe222025-08-12WarningsExact identifier
application applno (ANDA): 075357
application number: ANDA075357
YVTYVT DARK SPOTDARK SPOTBeijing JUNGE Technology Co., Ltd.352699fa-f746-c931-e063-6394a90a63912025-05-15WarningsExact identifier
application applno (ANDA): 075357
application number: ANDA075357
FEELSHION Lavender MagnesiumLAVENDER MAGNESIUMBeijing JUNGE Technology Co., Ltd.3513964e-dc5a-ab1e-e063-6294a90a993d2025-05-14WarningsExact identifier
application applno (ANDA): 075357
application number: ANDA075357
Arthcal ESTROGENESTROGENBeijing JUNGE Technology Co., Ltd.3515b12e-5c2e-2e7c-e063-6394a90aa6362025-05-14WarningsExact identifier
application applno (ANDA): 075357
application number: ANDA075357
QIDILA 5% Minoxidil foamMINOXIDIL BIIOTINBeijing JUNGE Technology Co., Ltd.3501c917-291d-9d4b-e063-6294a90a029c2025-05-13WarningsExact identifier
application applno (ANDA): 075357
application number: ANDA075357
FluMisch 5% Minoxidil5% MINOXIDILBeijing JUNGE Technology Co., Ltd.34ae3684-2d7f-ad66-e063-6394a90ae5972025-05-09WarningsExact identifier
application applno (ANDA): 075357
application number: ANDA075357
hair regrowth treatmentMINOXIDILCVS Pharmacycecabc88-2aa4-4095-88f3-eeb441001cdf2025-04-25WarningsExact identifier
application applno (ANDA): 075357
application number: ANDA075357
hers hair regrowth treatmentMINOXIDILHims Incd5d34755-9956-4782-8b27-4f31d407ff0c2025-04-25WarningsExact identifier
application applno (ANDA): 075357
application number: ANDA075357
up and up hair regrowth treatment for womenMINOXIDILTarget Corporatione1211429-46da-4824-9471-c421dae79d242025-04-25WarningsExact identifier
application applno (ANDA): 075357
application number: ANDA075357
Leader minoxidilMINOXIDILCardinal Health 110, LLC. dba Leader4955e5f1-b893-4a83-8fca-b199c67b1fb42025-04-24WarningsExact identifier
application applno (ANDA): 075357
application number: ANDA075357
minoxidil topicalMINOXIDILH E Bc9da0a80-2737-4e36-bbef-f7c4ae046ad72024-06-25WarningsExact identifier
application applno (ANDA): 075357
application number: ANDA075357
basic care hair regrowth treatmentMINOXIDILAmazon.com Services LLC84759a4b-2bac-4daf-a07c-34f6ceb52c682024-02-22WarningsExact identifier
application applno (ANDA): 075357
application number: ANDA075357
hair regrowth treatmentMINOXIDILWalgreen Company81eb8a45-2997-4614-8f95-215529a1b5622022-02-24WarningsExact identifier
application applno (ANDA): 075357
application number: ANDA075357
basic care hair regrowth treatmentMINOXIDILAmazon.com Services LLC89f70638-619f-4bc6-806e-5f685fdcb3792021-08-27WarningsExact identifier
application applno (ANDA): 075357
application number: ANDA075357

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-202-30378080202303 BOTTLE in 1 CARTON (37808-202-30) > 60 mL in 1 BOTTLE3 bottle2011-04-040000-00-00NoNoCurrent