FluMisch 5% Minoxidil

Product NDC
85212-0034
11-digit product format
852120034
Labeler code
85212
Product ID
85212-0034_34ae3684-2d80-ad66-e063-6394a90ae597
Type
HUMAN OTC DRUG
Nonproprietary name
5% Minoxidil
Dosage form
AEROSOL, FOAM
Route
EXTRACORPOREAL
Labeler
Beijing JUNGE Technology Co., Ltd.
Application
ANDA075357
Marketing category
ANDA
Marketing start
2025-01-01
Substance
BIOTIN; MINOXIDIL
Active strength
5; 5 g/100mL; 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
FluMisch 5% Minoxidil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BIOTIN5 g/100mL
MINOXIDIL5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6SO6U10H04Internal UNII lookup
5965120SH1Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2704021Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
34ae3684-2d7f-ad66-e063-6394a90ae597Available 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
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85212-0034-1FluMisch 5% Minoxidil1 mL in 1 BOXAEROSOL, FOAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85212-0034FLUMISCH 5% MINOXIDIL (5% MINOXIDIL) AEROSOL, FOAM [BEIJING JUNGE TECHNOLOGY CO., LTD.]1Current NDC, 1 package rows20250511_34ae3684-2d7f-ad66-e063-6394a90ae597.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
ndc (product): 85212-0034
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2704021biotin 5 % / minoxidil 5 % Topical FoamPSN34ae3684-2d7f-ad66-e063-6394a90ae5971
2704021biotin 50 MG/ML / minoxidil 50 MG/ML Topical FoamSCD34ae3684-2d7f-ad66-e063-6394a90ae5971
2704021biotin 5 % / minoxidil 5 % Topical FoamSY34ae3684-2d7f-ad66-e063-6394a90ae5971

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85212-0034-1852120034011 mL in 1 BOX (85212-0034-1) 1 ml2025-01-01NoNoCurrent