Minoxidil Topical Solution for Men

Manufacturer
Seiseidou America, Inc.
Effective date
2025-10-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:38:17

Label at a glance#

ProductHair Regrowth Treatment Extra Strength for Men
Active ingredientMINOXIDIL
Label structure9 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, USP 5% w/v

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.
Flammable: Keep away from fire or flame

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 solution 5% 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 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

Other information

OTHER SAFETY INFORMATION

  • 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.
  • hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with minoxidil topical solution 5% for men
  • In clinical studies with mostly white men aged 18 to 49 years with moderate degrees of hair loss, minoxidil topical solution 5% for men provided more hair regrowth than minoxidil topical solution 2%
  • store at controlled room temperature 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol (30% v/v), propylene glycol (50% v/v), purified water

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FOR MEN

EXTRA STRENGTH

NOT FOR USE BY WOMEN

MINOXIDIL TOPICAL SOLUTION, USP 5%

Hair Regrowth Treatment

FOR BEST RESULTS APPLY DIRECTLY TO SCALP TWICE DAILY

FOR EXTERNAL USE ONLY

ONE MONTH SUPPLY - ONE 60 mL (2fl oz) BOTTLE

Distributed by Seiseidou America

10880 Wilshire Blvd., Suite 1101

Los Angeles, CA 90024

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FORTERO Hair Regrowth Treatment
FORTERO Hair Regrowth Treatment

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311724minoxidil 5 % Topical SolutionPSN3
311724minoxidil 50 MG/ML Topical SolutionSCD3
311724minoxidil 3 GM per 60 ML Topical SolutionSY3
311724minoxidil 5 % Topical SolutionSY3
311724minoxidil 5 GM per 100 ML Topical SolutionSY3

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-130860003894606GTIN-13: 0860003894606
EAN-13: 0860003894606
GTIN-12: 860003894606
UPC-A: 860003894606
GTIN storage (14 digits): 00860003894606
minoxidil-topical--usp-5-percent-1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82269-607-02Hair Regrowth TreatmentExtra Strength for Men1 in 1 CARTONSOLUTION13
82269-607-02Hair Regrowth TreatmentExtra Strength for Men60 mL in 1 BOTTLE, DROPPERSOLUTION603

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
82269-60782269-607-02

Ingredients#

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

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22022-11-08full-release2026-05-31 23:51:26

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
A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)MINOXIDIL5%SOLUTION / TOPICAL2000-11-17

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 13:18:302026-09A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17c2088c7a36db…
2026-09-14 22:38:342026-08A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-1784e616aacf4f…
2026-08-18 06:07:402026-07A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-173f01610625f2…
2019-09-15 20:21 UTC2019-09A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-173a93d1ddd44b…

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
c568067f-a6db-4747-83fc-2cc935d1541c1bcb9934-861c-405a-948a-3e4cdd13246d2026-09-03WarningsExact identifier
spl set id: 1bcb9934-861c-405a-948a-3e4cdd13246d

Reported adverse events (FAERS/openFDA)#

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