FluMisch 5% Minoxidil

Manufacturer
Beijing JUNGE Technology Co., Ltd. | Zhejiang Ayan Biotech Co., Ltd.
Effective date
2025-05-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:00:45

Label at a glance#

ProductFluMisch 5% Minoxidil
Active ingredientBIOTIN, MINOXIDIL
Label structure12 sections

Label contents#

Full prescribing information#

ALARMS

For external use only.

Extremely Flammable: Avoid fire, flame, or smoking during andimmediately following application.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

swallowed, get medical help or contact a Poison Control Center rightaway.(1-800-222-1222)right away.

INACTIVE INGREDIENT SECTION

ALCOHOL
GLYCERIN
CETYL ALCOHOL
STEARYL ALCOHOL
POLYSORBATE 80
ANHYDROUS CITRIC ACID
LACTIC ACID
CASTOR OIL
.ALPHA.-TOCOPHEROL
EDETATE DISODIUM
WATER

DOSAGE & ADMINISTRATION SECTION

See enclosed leaflet for complete directions on how to use.
Apply half a capful twice daily directly to the scalp in the hair loss area
Massage into scalp with fingers, then wash hands well.
Using more or more often will not improve results.
Continued use is necessary to increase and keep your hair regrowthor hair loss will begin again.

OTC - WHEN USING SECTION

Do not use more than directed.

Do not apply on other parts of the body.

Avoid contact with the eyes, In case of accidental contact, rinse eyeswith large amounts of cool tap water.

For some women, you may need to use this product once a day forat least 6 months before you see results.

The amount of hair regrowth is different for each person. Thisproduct will not work for all women,

OTC - STOP USE SECTION

if chest pain, rapid heartbeat, faintness, or dizziness occurs

if sudden, unexplained weight gain occurs.

if your hands or feet swell.

if scalp irritation or redness occurs.

if unwanted facial hair growth occurs .

if you do not see hair regrowth in 6 months.

OTC - DO NOT USE SECTION

your degree of hair loss is different than that shown on side of thiscarton because this product may not work for you.

You have no family history of hair loss.

Your hair loss is sudden and/or patchy.

You do not know the reason for your hair loss.

Your hair loss is associated with childbirth.

You are under 18 years of age, Do not use on babies and children,

You use other medicines on the scalp.

Your scalp is red, inflamed, infected, irritated, or painful.

OTC - ACTIVE INGREDIENT SECTION

Minoxidil 5% Biotin 5%

WARNINGS SECTION

For external use only. Extremely Flammable: Avoid fire, flame, or smoking during andimmediately following application.

INDICATIONS & USAGE SECTION

Use to regrow hair on the top of the scalp

OTC - PURPOSE SECTION

Hair regrowth treatment

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Minoxidil FoamMinoxidil Foam

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2704021biotin 5 % / minoxidil 5 % Topical FoamPSN1
2704021biotin 50 MG/ML / minoxidil 50 MG/ML Topical FoamSCD1
2704021biotin 5 % / minoxidil 5 % Topical FoamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MINOXIDIL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85212-003485212-0034-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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
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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075357-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1999-07-3084e616aacf4f…
2026-09-14 22:38:342026-08A075357-002MINOXIDIL (FOR WOMEN)2%SOLUTION / TOPICAL1999-07-3084e616aacf4f…
2026-08-18 06:07:402026-07A075357-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1999-07-30caaa826d4ba7…
2026-08-18 06:07:402026-07A075357-002MINOXIDIL (FOR WOMEN)2%SOLUTION / TOPICAL1999-07-30caaa826d4ba7…
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…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluMisch 5% Minoxidil5% MINOXIDILBeijing JUNGE Technology Co., Ltd.34ae3684-2d7f-ad66-e063-6394a90ae5972025-05-09WarningsExact identifier
ndc (package): 85212-0034-1
ndc (product): 85212-0034
ndc11 (package): 85212003401
spl id: 34ae3684-2d80-ad66-e063-6394a90ae597
spl set id: 34ae3684-2d7f-ad66-e063-6394a90ae597

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.