FDA.reportPublic FDA data

Women's MinoGrow Hair Regrowth Treatment 2% Minoxidil Solution

Manufacturer
Minogro Products, LLC | Pure Source, LLC
Effective date
2026-02-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:36:32

Label at a glance#

ProductWomens MinoGrow Hair Regrowth Treatment Minoxidil
Active ingredientMINOXIDIL
Label structure8 sections

Dosage and administration

• apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area • 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 2% w/v

Purpose

OTC - PURPOSE SECTION

Hair regrowth treatment

Use

INDICATIONS & USAGE SECTION

to regrow hair on the scalp

Warnings

WARNINGS SECTION

For external use only.

Flammable:Keep away from fire or flame

Do not use if

OTC - DO NOT USE SECTION

• your amount of hair loss is different than that shown on the 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, and 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. You may need to use this product 2 times a day 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 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 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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• apply one mL with dropper 2 times a daydirectly onto the scalp in the hair loss area • 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

SPL UNCLASSIFIED SECTION

• see hair loss pictures on side of this carton • before use, read information on carton and enclosed leaflet • keep the carton. It contains important information. • In clinical students of mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response to 2% minoxidil topical solution was reported. 19% of women reported moderate hair regrowth, after using 2% minoxidil topical solution for 8 months (19% had moderate regrowth, 40% had minimal regrowth). This compares with 7% of women reporting moderate hair regrowth, 33% had minimal regrowth). 

• store at controlled room temperature 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol, Propylene Glycol, Purified Water

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free 1-813- 238-1123
Visit Website at www.minogrow.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Label0Outer Label0Inner Label0Inner Label0Package Insert0Package Insert0Package Insert2Package Insert2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311723minoxidil 2 % Topical SolutionPSN1
311723minoxidil 20 MG/ML Topical SolutionSCD1
311723minoxidil 2 % Topical SolutionSY1
311723minoxidil 2 GM per 100 ML Topical SolutionSY1

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130860014513305GTIN-13: 0860014513305
EAN-13: 0860014513305
GTIN-12: 860014513305
UPC-A: 860014513305
GTIN storage (14 digits): 00860014513305		Outer Label0.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87387-980-00Womens MinoGrow Hair Regrowth Treatment Minoxidil1 in 1 BOXSOLUTION11
87387-980-00Womens MinoGrow Hair Regrowth Treatment Minoxidil60 mL in 1 BOTTLE, DROPPERSOLUTION601

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
87387-98087387-980-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
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 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
A078176-001THEROXIDILMINOXIDIL2%SOLUTION / TOPICAL2007-11-09

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 13:18:302026-09A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09c2088c7a36db…
2026-09-14 22:38:342026-08A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-0984e616aacf4f…
2026-08-18 06:07:402026-07A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-0987673890dc5c…
2021-03-12 10:30 UTC2021-03A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-093f01610625f2…
2019-09-15 20:21 UTC2019-09A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09b00525d2431f…
2019-07-19 19:46 UTC2019-07A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-093a93d1ddd44b…

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
Womens MinoGrow Hair Regrowth Treatment MinoxidilMINOXIDILMinogro Products, LLC890c2acf-0c08-4c45-b29f-928b6155ca002026-02-03WarningsExact identifier
ndc (package): 87387-980-00
ndc (product): 87387-980
ndc11 (package): 87387098000
spl id: 49e94133-5d77-58fc-e063-6394a90acb2d
spl set id: 890c2acf-0c08-4c45-b29f-928b6155ca00

Reported adverse events (FAERS/openFDA)#

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