hair regrowth treatment

Product NDC
0363-0703
11-digit product format
003630703
Labeler code
0363
Product ID
0363-0703_1498b956-9e44-42f7-8b79-878de4ebe33f
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Walgreen Company
Application
ANDA075357
Marketing category
ANDA
Marketing start
2022-02-17
Substance
MINOXIDIL
Active strength
2 g/100mL
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 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…

Additional Listing Data#

Finished product
Yes
Brand name base
hair regrowth treatment
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL2 g/100mL

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
311723Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
81eb8a45-2997-4614-8f95-215529a1b562Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0703-16hair regrowth treatment1 in 1 CARTONSOLUTION12
0363-0703-16hair regrowth treatment60 mL in 1 BOTTLE, DROPPERSOLUTION602
0363-0703-30hair regrowth treatment60 mL in 1 BOTTLE, DROPPERSOLUTION602
0363-0703-30hair regrowth treatment3 in 1 CARTONSOLUTION32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0703HAIR REGROWTH TREATMENT (MINOXIDIL) SOLUTION [WALGREEN COMPANY]2Current NDC, Legacy NDC, 4 package rows20220310_81eb8a45-2997-4614-8f95-215529a1b562.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 · 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
ndc (product): 0363-0703
basic care hair regrowth treatmentMINOXIDILAmazon.com Services LLC89f70638-619f-4bc6-806e-5f685fdcb3792021-08-27WarningsExact identifier
application applno (ANDA): 075357
application number: ANDA075357

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311723minoxidil 2 % Topical SolutionPSN81eb8a45-2997-4614-8f95-215529a1b5622
311723minoxidil 20 MG/ML Topical SolutionSCD81eb8a45-2997-4614-8f95-215529a1b5622
311723minoxidil 2 % Topical SolutionSY81eb8a45-2997-4614-8f95-215529a1b5622
311723minoxidil 2 GM per 100 ML Topical SolutionSY81eb8a45-2997-4614-8f95-215529a1b5622

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-0703-16003630703161 BOTTLE, DROPPER in 1 CARTON (0363-0703-16) / 60 mL in 1 BOTTLE, DROPPER2022-02-240000-00-00NoNoCurrent
0363-0703-30003630703303 BOTTLE, DROPPER in 1 CARTON (0363-0703-30) / 60 mL in 1 BOTTLE, DROPPER2022-02-170000-00-00NoNoCurrent