Minoxidil Topical Solution for Men
- Manufacturer
- Roman Health Ventures Inc.
- Effective date
- 2025-01-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 00:51:32
Label at a glance#
ProductMinoxidil Extra Strength for Men
Active ingredientMINOXIDIL
Label structure13 sections
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
1 Bottle Carton
Active ingredient
Minoxidil, USP 5% w/v
3 Bottle Carton
Active ingredient
Minoxidil 5% w/v
OTC - PURPOSE SECTION
1 Bottle Carton
Purpose
Hair regrowth treatment for men
3 Bottle Carton
Purpose
Hair regrowth treatment
INDICATIONS & USAGE SECTION
1 Bottle Carton
Use to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)
3 Bottle Carton
Use to regrow hair on the scalp
WARNINGS SECTION
Warnings
For external use only. For use by men only.
Flammable: Keep away from fire or flame
OTC - DO NOT USE SECTION
Do not use if
- you are a woman
- your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. Minoxidil topical solution 5% 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
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have heart disease
OTC - WHEN USING SECTION
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.
OTC - STOP USE SECTION
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
OTC - PREGNANCY OR BREAST FEEDING SECTION
May be harmful if used when pregnant or breast-feeding.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
- apply one ml with dropper 2 times a day directly onto the scalp in the hair loss area
- 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
Other information
- 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.
- hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with minoxidil topical solution 5% for men
- In clinical studies with mostly white men aged 18 to 49 years with moderate degrees of hair loss, minoxidil topical solution 5% for men provided more hair regrowth than minoxidil topical solution 2%
- store at controlled room temperature 20° to 25°C (68° to 77°F)
INACTIVE INGREDIENT SECTION
Inactive ingredients Alcohol, propylene glycol, purified water
OTC - QUESTIONS SECTION
Questions? 1-424-347-6299 between 9:30 am and 9:00 pm EST, Monday–Friday.
SPL UNCLASSIFIED SECTION
Distributed by
Roman Health Ventures, Inc.
116 W. 23rd Street, 4th Floor
New York, NY 10011
getroman.com
SPL UNCLASSIFIED SECTION
NOT FOR USE BY WOMEN:
May grow facial hair. May be harmful if used during pregnancy or breast-feeding.
For best results, apply directly to scalp twice daily.
Minoxidil Topical Solution USP 5% is for men who have a general thinning of the hair on the top of the scalp (vertex only as shown below). Not intended for frontal baldness or a receding hairline. Minoxidil Topical Solution 5% for men has been shown to regrow hair in men with the following degrees of thinning hair or hair loss.
Single Bottle Package
NDC 72484-095-03
Men's Extra Strength
HAIR REGROWTH TREATMENT
roman MINOXIDIL TOPICAL SOLUTION USP 5%
Reactivates hair follicles to stimulate regrowth
Clinically proven to help regrow hair
NOT FOR USE BY WOMEN
Unscented Topical Solution
One month supply
One 60 mL (2 fl oz) Bottle
Three bottle package
NDC 72484-095-06
Men's Extra Strength
HAIR REGROWTH TREATMENT
roman
MINOXIDIL TOPICAL SOLUTION USP 5%
Reactivates hair follicles to stimulate regrowth
Clinically proven to help regrow hair
NOT FOR USE BY WOMEN
Unscented Topical Solution
Three month supply
Three 60 mL (2 fl oz) bottles
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| MINOXIDIL Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 72484-095-03 | 2023-06-09 | C162847 | 48780-1 | f386c649-c602-0266-e053-dadaa90a7c1a | Minoxidil Topical Solution for Men |
| 72484-095-06 | 2023-06-09 | C162847 | 48780-1 | f386c649-c602-0266-e053-dadaa90a7c1a | Minoxidil Topical Solution for Men |
| 72484-095-03 | 2023-01-30 | C162847 | 48780-1 | f386c649-c602-0266-e053-dadaa90a7c1a | Minoxidil Topical Solution for Men |
| 72484-095-06 | 2023-01-30 | C162847 | 48780-1 | f386c649-c602-0266-e053-dadaa90a7c1a | Minoxidil Topical Solution for Men |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72484-095-03 | MinoxidilExtra Strength for Men | 60 mL in 1 BOTTLE, DROPPER | SOLUTION | 60 | 5 | |
| 72484-095-03 | MinoxidilExtra Strength for Men | 1 in 1 CARTON | SOLUTION | 1 | 5 | |
| 72484-095-06 | MinoxidilExtra Strength for Men | 3 in 1 CARTON | SOLUTION | 3 | 5 | |
| 72484-095-06 | MinoxidilExtra Strength for Men | 60 mL in 1 BOTTLE, DROPPER | SOLUTION | 60 | 5 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Minoxidil Extra Strength for Men
- Minoxidil
- ALCOHOL
- PROPYLENE GLYCOL
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72484-095 | 72484-095-03, 72484-095-06 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ALCOHOL | 3K9958V90M | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| MINOXIDIL | 5965120SH1 | ACTIB |
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 |
|---|---|---|---|---|---|---|---|
| A076239-001 | THEROXIDIL | MINOXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 |
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 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | f41ea6bd6efb… |
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 Extra Strength for Men | MINOXIDIL | Roman Health Ventures Inc. | a568aba1-1016-4380-e053-2a95a90a396d | 2025-01-08 | Warnings | 72484-095-03 72484-095-06 72484-095 72484009503 72484009506 2b37005a-55da-d329-e063-6294a90af0da a568aba1-1016-4380-e053-2a95a90a396d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.