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#

ProductMinoxidil Extra Strength for Men
Active ingredientMINOXIDIL
Label structure13 sections

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

Distributed by

Roman Health Ventures, Inc.

116 W. 23rd Street, 4th Floor

New York, NY 10011

www.ro.co

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Minoxidil 3 BottleMinoxidil 3 Bottle

Single Bottle Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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.

Minoxidil Single PackageMinoxidil Single Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1537948minoxidil 5 % Topical SprayPSN4
1537948minoxidil 50 MG/ML Topical SpraySCD4
1537948minoxidil 5 % Topical SpraySY4

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72484-097-01MinoxidilExtra Strength for Men60 mL in 1 BOTTLE, SPRAYSPRAY604
72484-097-01MinoxidilExtra Strength for Men3 in 1 CARTONSPRAY34
72484-097-02MinoxidilExtra Strength for Men60 mL in 1 BOTTLE, SPRAYSPRAY604
72484-097-02MinoxidilExtra Strength for Men1 in 1 CARTONSPRAY14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72484-097MINOXIDIL EXTRA STRENGTH FOR MEN (MINOXIDIL) SPRAY [ROMAN HEALTH VENTURES INC.]4Current NDC, 4 package rows20250504_03738dd6-a42c-0986-e063-6294a90a1cc0.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72484-09772484-097-01, 72484-097-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 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 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076239-001THEROXIDILMINOXIDIL5%SOLUTION / TOPICAL2004-08-24

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.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24c2088c7a36db…
2026-09-14 22:38:342026-08A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-2484e616aacf4f…
2026-08-18 06:07:402026-07A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-2487673890dc5c…
2021-03-12 10:30 UTC2021-03A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-243f01610625f2…
2019-09-15 20:21 UTC2019-09A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24b00525d2431f…
2019-07-19 19:46 UTC2019-07A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-243a93d1ddd44b…

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
Minoxidil Extra Strength for MenMINOXIDILRoman Health Ventures Inc.03738dd6-a42c-0986-e063-6294a90a1cc02025-01-30WarningsExact identifier
ndc (package): 72484-097-02
ndc (package): 72484-097-01
ndc (product): 72484-097
ndc11 (package): 72484009701
ndc11 (package): 72484009702
spl id: 2cee657d-0af4-0821-e063-6294a90af06e
spl set id: 03738dd6-a42c-0986-e063-6294a90a1cc0

Reported adverse events (FAERS/openFDA)#

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