Minoxidil

Manufacturer
Walgreen Company
Effective date
2022-10-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:50:59

Label at a glance#

ProductMinoxidil (For Men)
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 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

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 carton and enclosed leaflet keep the carton. 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 t...

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.

Do not use if

OTC - DO NOT USE SECTION

  • 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

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

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. (1-800-222-1222)

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

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 carton and enclosed leaflet
  • keep the carton. 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

butylated hydroxytoluene, cetyl alcohol, citric acid anhydrous, dehydrated alcohol, isobutane, lactic acid, n-butane, polysorbate 60, propane, purified water, stearyl alcohol

Questions?

OTC - QUESTIONS SECTION

  • Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015

PRINCIPAL DISPLAY PANEL - 60 g Can Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0363-9090-01

Walgreens

Compare to the active
ingredient in Men's Rogaine®††

MINOXIDIL TOPICAL
AEROSOL, 5% (FOR MEN)

Hair
Regrowth
Treatment

For Men

Easy-to-Use Foam

Unscented

  • Reactivates hair follicles
    to stimulate regrowth
  • Clinically proven to help
    regrow hair
  • #1 dermatologist
    recommended
    active ingredient*

1
CAN

ONE-MONTH
SUPPLY
EASY-TO-USE
FOAM

2.11 OZ (60 g)

NOT FOR USE BY WOMEN

PRINCIPAL DISPLAY PANEL - 60 g Can Carton
PRINCIPAL DISPLAY PANEL - 60 g Can Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
645146minoxidil 5 % Topical FoamPSN2
645146minoxidil 50 MG/ML Topical FoamSCD2
645146minoxidil 5 % Topical FoamSY2

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-9090-01Minoxidil (For Men)1 in 1 CARTONAEROSOL, FOAM12
0363-9090-01Minoxidil (For Men)60 g in 1 CANAEROSOL, FOAM602
0363-9090-03Minoxidil (For Men)3 in 1 CARTONAEROSOL, FOAM32
0363-9090-03Minoxidil (For Men)60 g in 1 CANAEROSOL, FOAM602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9090MINOXIDIL (FOR MEN) (MINOXIDIL) AEROSOL, FOAM [WALGREEN COMPANY]2Current NDC, Legacy NDC, 4 package rows20221013_39526f7d-5e39-4e2e-8689-94b76ddbc462.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
0363-90900363-9090-01, 0363-9090-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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 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
A209074-001MINOXIDIL (FOR MEN)MINOXIDIL5%AEROSOL, FOAM / TOPICAL2018-12-31
A209074-002MINOXIDIL (FOR WOMEN)MINOXIDIL5%AEROSOL, FOAM / TOPICAL2019-04-22

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 22:38:342026-08A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-3184e616aacf4f…
2026-09-14 22:38:342026-08A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-2284e616aacf4f…
2026-08-18 06:07:402026-07A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-31caaa826d4ba7…
2026-08-18 06:07:402026-07A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209074-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2018-12-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A209074-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2019-04-2274a2ff9319b5…

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 (For Men)MINOXIDILWalgreen Company39526f7d-5e39-4e2e-8689-94b76ddbc4622022-10-10WarningsExact identifier
ndc (package): 0363-9090-03
ndc (package): 0363-9090-01
ndc (product): 0363-9090
ndc11 (package): 00363909003
ndc11 (package): 00363909001
spl id: 5076e3b7-04a0-40ce-91f9-dc63e9f14b9f
spl set id: 39526f7d-5e39-4e2e-8689-94b76ddbc462

Reported adverse events (FAERS/openFDA)#

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