FDA.reportPublic FDA data

Mens rogaine Minoxidil

Manufacturer
Kenvue Brands LLC
Effective date
2024-11-11
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:36:46

Label at a glance#

ProductMens rogaine Minoxidil - Unscented Formula
Active ingredientMINOXIDIL
Label structure11 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 booklet 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

Storage and handling

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 package and enclosed booklet keep the package. 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...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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 this carton)

Warnings

WARNINGS SECTION

For external use only. For use by men only.

Extremely Flammable

SPL UNCLASSIFIED SECTION

Avoid fire, flame, or smoking during and immediately following application.

OTC - DO NOT USE SECTION

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

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.

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 booklet 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

STORAGE AND HANDLING SECTION

  • 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 package and enclosed booklet
  • keep the package. 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 ingredients

INACTIVE INGREDIENT SECTION

butane, butylated hydroxytoluene, cetyl alcohol, citric acid, glycerin, isobutane, lactic acid, polysorbate 60, propane, purified water, SD alcohol40-B, stearyl alcohol

Questions?

OTC - QUESTIONS SECTION

  • call toll-free 800-ROGAINE or 215-273-8755 (collect)
  • visit www.rogaine.com

SPL UNCLASSIFIED SECTION

Distributed by:
JOHNSON & JOHNSON CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - Three 60 g Can Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1 DERMATOLOGIST RECOMMENDED BRAND

MEN'S

Rogaine ®

5% MINOXIDIL TOPICAL AEROSOL

HAIR REGROWTH TREATMENT

REACTIVATES

HAIR FOLLICLES

TO STIMULATE REGROWTH

EASY-TO-USE

FOAM

CLINICALLY PROVEN TO HELP REGROW HAIR

UNSCENTED

Not For Use By Women

Three Month Supply • Three 60 g (2.11 oz) Cans

Rogaine 001Rogaine 001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
645146minoxidil 5 % Topical FoamPSN7
702354Rogaine 5 % Topical FoamPSN7
702354minoxidil 50 MG/ML Topical Foam [Rogaine]SBD7
645146minoxidil 50 MG/ML Topical FoamSCD7
645146minoxidil 5 % Topical FoamSY7
702354Rogaine 5 % Topical FoamSY7
702354Rogaine 50 MG/ML Topical FoamSY7

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0031-1Mens rogaine Minoxidil - Unscented Formula1 in 1 PACKAGEAEROSOL, FOAM17
69968-0031-1Mens rogaine Minoxidil - Unscented Formula60 g in 1 CANAEROSOL, FOAM607
69968-0031-3Mens rogaine Minoxidil - Unscented Formula60 g in 1 CANAEROSOL, FOAM607
69968-0031-3Mens rogaine Minoxidil - Unscented Formula3 in 1 PACKAGEAEROSOL, FOAM37
69968-0031-4Mens rogaine Minoxidil - Unscented Formula4 in 1 PACKAGEAEROSOL, FOAM47
69968-0031-4Mens rogaine Minoxidil - Unscented Formula60 g in 1 CANAEROSOL, FOAM607

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0031MENS ROGAINE MINOXIDIL - UNSCENTED FORMULA (MINOXIDIL) AEROSOL, FOAM [KENVUE BRANDS LLC]7Current NDC, Legacy NDC, 6 package rows20241114_1b5e2860-6855-4a65-8bbc-e064172a1adf.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69968-0031-1GM - Gram69968-0031a9a6aef7-35ac-44bd-9fbe-bc6f7f0b64a212018-07-03
69968-0031-3GM - Gram69968-0031f9d15c93-3b45-4b3c-90ef-28d945dbc0a512018-08-13

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-003169968-0031-1, 69968-0031-3, 69968-0031-4

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
BUTANE6LV4FOR43RIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
CETYL ALCOHOL936JST6JCNIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
ISOBUTANEBXR49TP611IACT
LACTIC ACID, UNSPECIFIED FORM33X04XA5ATIACT
POLYSORBATE 60CAL22UVI4MIACT
PROPANET75W9911L6IACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
STEARYL ALCOHOL2KR89I4H1YIACT
MINOXIDIL5965120SH1ACTIB

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 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
N021812-001MEN'S ROGAINEMINOXIDIL5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-20
N021812-002WOMEN'S ROGAINEMINOXIDIL5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-28

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 22:38:342026-08N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-2084e616aacf4f…
2026-09-14 22:38:342026-08N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-2884e616aacf4f…
2026-08-18 06:07:402026-07N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-20caaa826d4ba7…
2026-08-18 06:07:402026-07N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-20d06236e962d9…
2024-10-29 15:01 UTC2024-10N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-205c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-205d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-204b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021812-001MEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2006-01-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021812-002WOMEN'S ROGAINE5%AEROSOL, FOAM / TOPICALRLD, RS2014-02-2874a2ff9319b5…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021812-00169461202019-04-20U-702Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021812-00269461202019-04-20U-702Drug product2015-01-2174a2ff9319b5…
2019-12-14 00:12 UTC2019-12N021812-00169461202019-04-20U-702Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021812-00269461202019-04-20U-702Drug product2015-01-213f01610625f2…
2019-09-15 20:21 UTC2019-09N021812-00169461202019-04-20U-702Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021812-00269461202019-04-20U-702Drug product2015-01-21b00525d2431f…
2019-07-19 19:46 UTC2019-07N021812-00169461202019-04-20U-702Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021812-00269461202019-04-20U-702Drug product2015-01-21ea99ee380514…

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
Mens rogaine Minoxidil Unscented FormulaMINOXIDILKenvue Brands LLC1b5e2860-6855-4a65-8bbc-e064172a1adf2024-11-11WarningsExact identifier
ndc (package): 69968-0031-3
ndc (package): 69968-0031-4
ndc (package): 69968-0031-1
ndc (product): 69968-0031
ndc11 (package): 69968003101
ndc11 (package): 69968003104
ndc11 (package): 69968003103
spl id: 2163626e-0033-3de8-e063-6294a90a9cfd
spl set id: 1b5e2860-6855-4a65-8bbc-e064172a1adf

Reported adverse events (FAERS/openFDA)#

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