FDA.reportPublic FDA data

Minoxidil Topical Solution for Men

Manufacturer
P & L Development, LLC
Effective date
2024-11-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:34:13

Label at a glance#

ProductMinoxidil
Active ingredientMINOXIDIL
Label structure10 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Minoxidil 5% w/w (without propellant)

Purpose

OTC - PURPOSE SECTION

Hair regrowth treatment for men

Use

INDICATIONS & USAGE SECTION

to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)

Warnings

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

OTC - DO NOT USE SECTION

  • 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 Aerosol 5% (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 

OTC - ASK DOCTOR SECTION

heart disease

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

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 information

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 20º to 25ºC (68º to 77ºF)
  • contents under pressure. Do not puncture or incinerate container.
  • Do not expose to heat or store at temperature above 120ºF (49ºC).

Inactive ingredients

INACTIVE INGREDIENT SECTION

butane, butylated hydroxytoluene, cetyl alcohol, citric acid, glycerin, isobutane,lactic acid, polysorbate 60, propane, purified water, SD alcohol,40-B, stearyl alcohol

Questions?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to active ingredient in Men's Rogaine®

Men's

Hair Regrowth Treatment

Minoxidil Topical Aerosol, 5%

  • Clinically proven to help regrow hair
  • Reactivates hair follicles to stimulate regrowth
  • Unscented

EASY-TO-USE FOAM

Not For Use By Women

1 CAN

60 g (2.11OZ CAN

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Men's Rogaine®.

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Men's Hair Regrowth Treatment
Men's Hair Regrowth Treatment

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
645146minoxidil 5 % Topical FoamPSN4
645146minoxidil 50 MG/ML Topical FoamSCD4
645146minoxidil 5 % Topical FoamSY4

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59726-115-60Minoxidil60 g in 1 CANAEROSOL, FOAM604
59726-115-65Minoxidil60 g in 1 CANAEROSOL, FOAM604
59726-115-65Minoxidil2 in 1 PACKAGEAEROSOL, FOAM24
59726-115-70Minoxidil3 in 1 PACKAGEAEROSOL, FOAM34
59726-115-70Minoxidil60 g in 1 CANAEROSOL, FOAM604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59726-115MINOXIDIL AEROSOL, FOAM [P & L DEVELOPMENT, LLC]4Current NDC, 5 package rows20241106_73dc7e7f-92c2-4ab2-a260-ceb198e591cf.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59726-11559726-115-60, 59726-115-70, 59726-115-65

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
MINOXIDIL5965120SH1ACTIB
BUTANE6LV4FOR43RIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
CETYL ALCOHOL936JST6JCNIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
ISOBUTANEBXR49TP611IACT
LACTIC ACID33X04XA5ATIACT
POLYSORBATE 60CAL22UVI4MIACT
PROPANET75W9911L6IACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
STEARYL ALCOHOL2KR89I4H1YIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32023-05-05full-release2026-05-31 23:54:54

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 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208092-001MINOXIDIL (FOR MEN)MINOXIDIL5%AEROSOL, FOAM / TOPICAL2017-02-17
A208092-002MINOXIDIL (FOR WOMEN)MINOXIDIL5%AEROSOL, FOAM / TOPICAL2017-07-27

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-1784e616aacf4f…
2026-09-14 22:38:342026-08A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-2784e616aacf4f…
2026-08-18 06:07:402026-07A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-17caaa826d4ba7…
2026-08-18 06:07:402026-07A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208092-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2017-02-1774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A208092-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2017-07-2774a2ff9319b5…

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
MinoxidilMINOXIDILP & L Development, LLC73dc7e7f-92c2-4ab2-a260-ceb198e591cf2024-11-05WarningsExact identifier
ndc (package): 59726-115-70
ndc (package): 59726-115-65
ndc (package): 59726-115-60
ndc (product): 59726-115
ndc11 (package): 59726011565
ndc11 (package): 59726011560
ndc11 (package): 59726011570
spl id: 718a6b1f-b594-488d-8b9d-00891cb478f3
spl set id: 73dc7e7f-92c2-4ab2-a260-ceb198e591cf

Reported adverse events (FAERS/openFDA)#

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