Minoxidil Spray
- Manufacturer
- Roman Health Ventures Inc.
- Effective date
- 2025-01-30
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 01:00:16
Label at a glance#
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 scalp (vertex only, see picture on side of carton) 3 Bottle Carton Use to regrow hair on the scalp (vertex only, see picture on side of carton) |
WARNINGS SECTION
Warnings
For external use only. For use by men only.
Flammable: Keep away from fire or flame
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
DOSAGE & ADMINISTRATION SECTION
Directions
Prime the sprayer by holding the bottle the bottle upright and pump the sprayer 5 times to ensure delivery of full spray. Do not inhale mist
Apply one mL with spray (6 sprays) 2 times a day directly onto the scalp in the hair loss area
Using more or more often will not improve restuls
Continued use is necessary to increase and keep your hair regrowth, or hair loss will begind 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
Hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men
Keep the carton. It contains important information.
In clinical studies of mostly white men aged 18-45 years with moderate degrees of hairloss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution
Store at controlled room temperature 20 to 25C (68 to 77F)
INACTIVE INGREDIENT SECTION
Inactive ingredients Alcohol, propylene glycol, purified water
OTC - QUESTIONS SECTION
| Questions? 1-424-347-6299 Visit website at ro.co |
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
NOT FOR USE BY WOMEN:
May grow facial hair. May be harmful if used during pregnancy or breast-feeding
Minoxidil 5% Topical Solution, USP
Minoxidil 5% Topical Solution
is for men who have a general
thinning of hair on the top of
the scalp vertex only, as
shown below. Not intended
for frontabl baldness or a
receding hairline. Minoxidil
Topical Solution 5% has been
shown to regrow hair in men
with the following degrees of
thinning hair or hairloss.
If men have more hair loss or hair loss in
a place different than showing above, Minoxidil
Topical Solution 5% for men may not work.
For best results:
Apply direclty to scalp. Use twice daily.
Three Bottle Package
NDC xxxxx-xxx-xx
roman
HAIR
REGROWTH
TREATMENT
5% Minoxidil Topical Solution, USP
Extra Strength formula for men
Clinically proven to help regrow hair
Reactivates hair follicles to stimulate growth
Easy precision sprayer
Unscented topical solution
Three month supply
3- 60 mL (2 fl oz) bottles
Total 180 mL (6 fl oz)
Not for use by women
Single Bottle Package
NDC XXXXX-XXX-XX
roman
Hair Regrowth Treatment
5% Minoxidil Topical Solution, USP
Extra Strength formula for men
Clinically proven to help regrow hair
Reactivates hair follicales to stimulate regrowth
Easy precision sprayer
Unscented topical solution
One month supply
1 - 60 mL (2 fl oz) bottle
Not for use by women.
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 |
|---|---|---|---|
| 3c386306-c48a-413e-bb69-70cb268496f3 | Product name | 1 | 20210727 |
| 7792dadb-52b6-46b6-8fdf-80b1171065b5 | Product name | 1 | 20180810 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72484-097-01 | MinoxidilExtra Strength for Men | 60 mL in 1 BOTTLE, SPRAY | SPRAY | 60 | 4 | |
| 72484-097-01 | MinoxidilExtra Strength for Men | 3 in 1 CARTON | SPRAY | 3 | 4 | |
| 72484-097-02 | MinoxidilExtra Strength for Men | 60 mL in 1 BOTTLE, SPRAY | SPRAY | 60 | 4 | |
| 72484-097-02 | MinoxidilExtra Strength for Men | 1 in 1 CARTON | SPRAY | 1 | 4 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Minoxidil Extra Strength for Men
- Minoxidil
- ALCOHOL
- WATER
- PROPYLENE GLYCOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72484-097 | 72484-097-01, 72484-097-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MINOXIDIL | 5965120SH1 | ACTIB |
| ALCOHOL | 3K9958V90M | IACT |
| WATER | 059QF0KO0R | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | 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 |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | c2088c7a36db… | ||
| 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… |
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. | 03738dd6-a42c-0986-e063-6294a90a1cc0 | 2025-01-30 | Warnings | 72484-097-02 72484-097-01 72484-097 72484009701 72484009702 2cee657d-0af4-0821-e063-6294a90af06e 03738dd6-a42c-0986-e063-6294a90a1cc0 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

