Minoxidil
- Manufacturer
- RESTORATION HOLDINGS, LLC | Taro Pharmaceutical
- Effective date
- 2024-12-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- full-release
- Hydrated at
- 2026-06-01 00:42:10
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Minoxidil 5% w/w (without propellant)
OTC - PURPOSE SECTION
Hair regrowth treatment for men
WARNINGS SECTION
For external use only.
For use by men only.
Extremely Flammable: Avoid fire, flame, or smoking during and immediately following application.
Do not use if
- you are a woman
- your amount of hair loss is different than that shown on side of this carton or your hair loss is on the front of the scalp. 5% minoxidil topical foam is not intended for frontal baldness or receding hairline.
- 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
- you are under 18 years of age. Do not use on babies and children.
- your scalp is red, inflamed, infected, irritated, or painful
- you use other medicines on the scalp
Ask a doctor before use if you have heart disease
When using this product
- do not apply on other parts of the body
- avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.
- some people have experienced changes in hair color and/or texture
- it takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results.
- the amount of hair regrowth is different for each person. This product will not work for all men.
Stop use and ask a doctor if
- chest pain, rapid heartbeat, faintness, or dizziness occurs
- sudden, unexplained weight gain occurs
- your hands or feet swell
- scalp irritation or redness occurs
- unwanted facial hair growth occurs
- you do not see hair regrowth in 4 months
May be harmful if used when pregnant or breast-feeding.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
DOSAGE & ADMINISTRATION SECTION
- apply half a capful 2 times a day to the scalp in the hair loss area
- massage into scalp with fingers, then wash hands well
- see enclosed leaflet for complete directions on how to use
- using more or more often will not improve results
- continued use is necessary to increase and keep your hair regrowth or hair loss will begin again
OTHER SAFETY INFORMATION
- hair growth has been shown in a clinical study of men (mostly white) aged 18-49 years who used it for 4 months
- see hair loss pictures on side of this carton
- before use, read all information on carton and enclosed leaflet
- keep the carton. It contains important information.
- store at controlled room temperature 20° to 25°C (68° to 77°F)
- contents under pressure. Do not puncture or incinerate container.
- do not expose to heat or store at temperatures above 120°F (49°C).
INACTIVE INGREDIENT SECTION
butylated hydroxytoluene, cetyl alcohol, citric acid anhydrous, dehydrated alcohol, isobutane, lactic acid, n-butane, polysorbate 60, propane, purified water, stearyl alcohol
OTC - QUESTIONS SECTION
- Call 1-866-923-4914
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
INDICATIONS & USAGE SECTION
to regrow hair on the top of the scalp (vertex only, see pictures on side of this carton)
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 Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82796-100-01 | Minoxidil(for Men) | 1 in 1 BOX | AEROSOL, FOAM | 1 | 7 | |
| 82796-100-01 | Minoxidil(for Men) | 60 g in 1 CONTAINER | AEROSOL, FOAM | 60 | 7 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Minoxidil (for Men)
- Minoxidil
- BUTYLATED HYDROXYTOLUENE
- ANHYDROUS CITRIC ACID
- BUTANE
- LACTIC ACID, UNSPECIFIED FORM
- ISOBUTANE
- ALCOHOL
- WATER
- STEARYL ALCOHOL
- CETYL ALCOHOL
- PROPANE
- POLYSORBATE 60
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 82796-100 | 82796-100-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| BUTANE | 6LV4FOR43R | IACT |
| LACTIC ACID, UNSPECIFIED FORM | 33X04XA5AT | IACT |
| MINOXIDIL | 5965120SH1 | ACTIB |
| ISOBUTANE | BXR49TP611 | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| WATER | 059QF0KO0R | IACT |
| STEARYL ALCOHOL | 2KR89I4H1Y | IACT |
| CETYL ALCOHOL | 936JST6JCN | IACT |
| PROPANE | T75W9911L6 | IACT |
| POLYSORBATE 60 | CAL22UVI4M | 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 |
|---|---|---|---|---|---|---|---|
| A209074-001 | MINOXIDIL (FOR MEN) | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2018-12-31 | ||
| A209074-002 | MINOXIDIL (FOR WOMEN) | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2019-04-22 |
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 | A209074-001 | MINOXIDIL (FOR MEN) | 5% | AEROSOL, FOAM / TOPICAL | 2018-12-31 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A209074-002 | MINOXIDIL (FOR WOMEN) | 5% | AEROSOL, FOAM / TOPICAL | 2019-04-22 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A209074-001 | MINOXIDIL (FOR MEN) | 5% | AEROSOL, FOAM / TOPICAL | 2018-12-31 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A209074-002 | MINOXIDIL (FOR WOMEN) | 5% | AEROSOL, FOAM / TOPICAL | 2019-04-22 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A209074-001 | MINOXIDIL (FOR MEN) | 5% | AEROSOL, FOAM / TOPICAL | 2018-12-31 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A209074-002 | MINOXIDIL (FOR WOMEN) | 5% | AEROSOL, FOAM / TOPICAL | 2019-04-22 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209074-001 | MINOXIDIL (FOR MEN) | 5% | AEROSOL, FOAM / TOPICAL | 2018-12-31 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209074-002 | MINOXIDIL (FOR WOMEN) | 5% | AEROSOL, FOAM / TOPICAL | 2019-04-22 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A209074-001 | MINOXIDIL (FOR MEN) | 5% | AEROSOL, FOAM / TOPICAL | 2018-12-31 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A209074-002 | MINOXIDIL (FOR WOMEN) | 5% | AEROSOL, FOAM / TOPICAL | 2019-04-22 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209074-001 | MINOXIDIL (FOR MEN) | 5% | AEROSOL, FOAM / TOPICAL | 2018-12-31 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209074-002 | MINOXIDIL (FOR WOMEN) | 5% | AEROSOL, FOAM / TOPICAL | 2019-04-22 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209074-001 | MINOXIDIL (FOR MEN) | 5% | AEROSOL, FOAM / TOPICAL | 2018-12-31 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209074-002 | MINOXIDIL (FOR WOMEN) | 5% | AEROSOL, FOAM / TOPICAL | 2019-04-22 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209074-001 | MINOXIDIL (FOR MEN) | 5% | AEROSOL, FOAM / TOPICAL | 2018-12-31 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209074-002 | MINOXIDIL (FOR WOMEN) | 5% | AEROSOL, FOAM / TOPICAL | 2019-04-22 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209074-001 | MINOXIDIL (FOR MEN) | 5% | AEROSOL, FOAM / TOPICAL | 2018-12-31 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209074-002 | MINOXIDIL (FOR WOMEN) | 5% | AEROSOL, FOAM / TOPICAL | 2019-04-22 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209074-001 | MINOXIDIL (FOR MEN) | 5% | AEROSOL, FOAM / TOPICAL | 2018-12-31 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209074-002 | MINOXIDIL (FOR WOMEN) | 5% | AEROSOL, FOAM / TOPICAL | 2019-04-22 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209074-001 | MINOXIDIL (FOR MEN) | 5% | AEROSOL, FOAM / TOPICAL | 2018-12-31 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209074-002 | MINOXIDIL (FOR WOMEN) | 5% | AEROSOL, FOAM / TOPICAL | 2019-04-22 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A209074-001 | MINOXIDIL (FOR MEN) | 5% | AEROSOL, FOAM / TOPICAL | 2018-12-31 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A209074-002 | MINOXIDIL (FOR WOMEN) | 5% | AEROSOL, FOAM / TOPICAL | 2019-04-22 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209074-001 | MINOXIDIL (FOR MEN) | 5% | AEROSOL, FOAM / TOPICAL | 2018-12-31 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209074-002 | MINOXIDIL (FOR WOMEN) | 5% | AEROSOL, FOAM / TOPICAL | 2019-04-22 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209074-001 | MINOXIDIL (FOR MEN) | 5% | AEROSOL, FOAM / TOPICAL | 2018-12-31 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209074-002 | MINOXIDIL (FOR WOMEN) | 5% | AEROSOL, FOAM / TOPICAL | 2019-04-22 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209074-001 | MINOXIDIL (FOR MEN) | 5% | AEROSOL, FOAM / TOPICAL | 2018-12-31 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209074-002 | MINOXIDIL (FOR WOMEN) | 5% | AEROSOL, FOAM / TOPICAL | 2019-04-22 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A209074-001 | MINOXIDIL (FOR MEN) | 5% | AEROSOL, FOAM / TOPICAL | 2018-12-31 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A209074-002 | MINOXIDIL (FOR WOMEN) | 5% | AEROSOL, FOAM / TOPICAL | 2019-04-22 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209074-001 | MINOXIDIL (FOR MEN) | 5% | AEROSOL, FOAM / TOPICAL | 2018-12-31 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209074-002 | MINOXIDIL (FOR WOMEN) | 5% | AEROSOL, FOAM / TOPICAL | 2019-04-22 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A209074-001 | MINOXIDIL (FOR MEN) | 5% | AEROSOL, FOAM / TOPICAL | 2018-12-31 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A209074-002 | MINOXIDIL (FOR WOMEN) | 5% | AEROSOL, FOAM / TOPICAL | 2019-04-22 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A209074-001 | MINOXIDIL (FOR MEN) | 5% | AEROSOL, FOAM / TOPICAL | 2018-12-31 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A209074-002 | MINOXIDIL (FOR WOMEN) | 5% | AEROSOL, FOAM / TOPICAL | 2019-04-22 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A209074-001 | MINOXIDIL (FOR MEN) | 5% | AEROSOL, FOAM / TOPICAL | 2018-12-31 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A209074-002 | MINOXIDIL (FOR WOMEN) | 5% | AEROSOL, FOAM / TOPICAL | 2019-04-22 | 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 |
|---|---|---|---|---|---|---|
| Minoxidil (for Men) | MINOXIDIL | RESTORATION HOLDINGS, LLC | e18223ad-642e-81a5-e053-2a95a90a0752 | 2024-12-11 | Warnings | 82796-100-01 82796-100 82796010001 28f9ca10-20c6-b301-e063-6294a90af33c e18223ad-642e-81a5-e053-2a95a90a0752 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
