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#
Contacts and useful links#
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
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| MINOXIDIL Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 444b3e50-f226-46ef-bfca-2e7035d140cd | Product name | 1 | 20190611 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 597b1cfd-7b31-5048-62be-ca5cd740da2f | Product name | 1 | 20140508 |
| ec2149b3-5c6d-5344-f757-c86411073075 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85212-0034-1 | FluMisch 5% Minoxidil | 1 mL in 1 BOX | AEROSOL, FOAM | 1 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 85212-0034 | FLUMISCH 5% MINOXIDIL (5% MINOXIDIL) AEROSOL, FOAM [BEIJING JUNGE TECHNOLOGY CO., LTD.] | 1 | Current NDC, 1 package rows | 20250511_34ae3684-2d7f-ad66-e063-6394a90ae597.zip |
Products#
Every source-derived product name is available through these pages.
- FluMisch 5% Minoxidil
- 5% Minoxidil
- BIOTIN
- LACTIC ACID
- POLYSORBATE 80
- CASTOR OIL
- CETYL ALCOHOL
- STEARYL ALCOHOL
- MINOXIDIL
- GLYCERIN
- WATER
- ANHYDROUS CITRIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 85212-0034 | 85212-0034-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BIOTIN | 6SO6U10H04 | ACTIB |
| LACTIC ACID | 33X04XA5AT | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| CASTOR OIL | D5340Y2I9G | IACT |
| CETYL ALCOHOL | 936JST6JCN | IACT |
| STEARYL ALCOHOL | 2KR89I4H1Y | IACT |
| MINOXIDIL | 5965120SH1 | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
| WATER | 059QF0KO0R | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075357-001 | MINOXIDIL (FOR MEN) | MINOXIDIL | 2% | SOLUTION / TOPICAL | 1999-07-30 | ||
| A075357-002 | MINOXIDIL (FOR WOMEN) | MINOXIDIL | 2% | SOLUTION / TOPICAL | 1999-07-30 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A075357-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A075357-002 | MINOXIDIL (FOR WOMEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075357-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075357-002 | MINOXIDIL (FOR WOMEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075357-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075357-002 | MINOXIDIL (FOR WOMEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075357-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075357-002 | MINOXIDIL (FOR WOMEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075357-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075357-002 | MINOXIDIL (FOR WOMEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075357-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075357-002 | MINOXIDIL (FOR WOMEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075357-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075357-002 | MINOXIDIL (FOR WOMEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075357-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075357-002 | MINOXIDIL (FOR WOMEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075357-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075357-002 | MINOXIDIL (FOR WOMEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075357-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075357-002 | MINOXIDIL (FOR WOMEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075357-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075357-002 | MINOXIDIL (FOR WOMEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A075357-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A075357-002 | MINOXIDIL (FOR WOMEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075357-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075357-002 | MINOXIDIL (FOR WOMEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075357-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075357-002 | MINOXIDIL (FOR WOMEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075357-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075357-002 | MINOXIDIL (FOR WOMEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A075357-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A075357-002 | MINOXIDIL (FOR WOMEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075357-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075357-002 | MINOXIDIL (FOR WOMEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A075357-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A075357-002 | MINOXIDIL (FOR WOMEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A075357-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A075357-002 | MINOXIDIL (FOR WOMEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A075357-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A075357-002 | MINOXIDIL (FOR WOMEN) | 2% | SOLUTION / TOPICAL | 1999-07-30 | 74a2ff9319b5… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| FluMisch 5% Minoxidil | 5% MINOXIDIL | Beijing JUNGE Technology Co., Ltd. | 34ae3684-2d7f-ad66-e063-6394a90ae597 | 2025-05-09 | Warnings | 85212-0034-1 85212-0034 85212003401 34ae3684-2d80-ad66-e063-6394a90ae597 34ae3684-2d7f-ad66-e063-6394a90ae597 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
