FDA.reportPublic FDA data

Minoxidil Topical Aerosol, 5% (For Women)

Manufacturer
Sun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries Ltd.
Effective date
2026-09-10
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
daily-update
Hydrated at
2026-09-15 03:01:31

Label at a glance#

ProductMinoxidil For Women
Active ingredientMINOXIDIL
Label structure13 sections

Dosage and administration

see enclosed leaflet for complete directions on how to use apply half a capful once daily directly to the scalp in the hair loss area massage into scalp with fingers, then wash hands well 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

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).

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 women

Use

INDICATIONS & USAGE SECTION

to regrow hair on the top of the scalp (see pictures on side of this carton)

Warnings

WARNINGS SECTION

For external use only.

SPL UNCLASSIFIED SECTION

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

Do not use if

OTC - DO NOT USE SECTION

  • your degree of hair loss is different than that shown on side of this carton because this product may not work for you
  • you have no family history of hair loss
  • your hair loss is sudden and/or patchy
  • your hair loss is associated with childbirth
  • 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 use more than directed
  • 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 3 months with once-daily use. For some women, you may need to use this product once a day for at least 6 months before you see results.
  • the amount of hair regrowth is different for each person. This product will not work for all women.

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • see enclosed leaflet for complete directions on how to use
  • apply half a capful once daily directly to the scalp in the hair loss area
  • massage into scalp with fingers, then wash hands well
  • 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

  • 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:
Ohm Laboratories, Inc.
New Brunswick, NJ 08901

Product of Italy

PRINCIPAL DISPLAY PANEL - 60 g Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 51672-2129-4

Minoxidil Topical Aerosol,

5% (For Women)

Two Month Supply
One 60 g (2.11 oz) Can

CartonCarton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

PRINCIPAL DISPLAY PANEL - 60 g Can

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 51672-2129-4

Two Month Supply
One 60 g (2.11 oz) Can

CanisterCanister

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130351672212940GTIN-13: 0351672212940
EAN-13: 0351672212940
GTIN-12: 351672212940
UPC-A: 351672212940
GTIN storage (14 digits): 00351672212940		Minoxidil Topical Foam (Womens) 1pk Carton.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-2129-4GM - Gram51672-21295ba5eca6-9b43-4fb9-9d62-a787c5800c9b12023-08-08

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
51672-212951672-2129-4, 51672-2129-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
MINOXIDIL5965120SH1ACTIB
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
CETYL ALCOHOL936JST6JCNIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
ALCOHOL3K9958V90MIACT
ISOBUTANEBXR49TP611IACT
LACTIC ACID, UNSPECIFIED FORM33X04XA5ATIACT
BUTANE6LV4FOR43RIACT
POLYSORBATE 60CAL22UVI4MIACT
PROPANET75W9911L6IACT
WATER059QF0KO0RIACT
STEARYL ALCOHOL2KR89I4H1YIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92026-03-10full-release2026-06-01 01:49:45
72026-02-09monthly-update2026-06-03 17:56:20

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
4cb10c82-6bd3-5d62-e063-6394a90afdc982d7a480-46b2-423b-8da0-a4fc252f77472026-03-10WarningsExact identifier
spl set id: 82d7a480-46b2-423b-8da0-a4fc252f7747

Reported adverse events (FAERS/openFDA)#

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