Mens Extra Strength Minoxidil Hair Growth Treatment

Product NDC
87616-969
11-digit product format
876160969
Labeler code
87616
Product ID
87616-969_50ab4a95-ef37-f7ca-e063-6394a90a61b8
Type
HUMAN OTC DRUG
Nonproprietary name
MINOXIDIL
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Hairmax International, LLC
Application
ANDA076239
Marketing category
ANDA
Marketing start
2026-03-09
Substance
MINOXIDIL
Active strength
50 mg/mL
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076239-001THEROXIDILMINOXIDIL5%SOLUTION / TOPICAL2004-08-24

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mens Extra Strength Minoxidil Hair Growth TreatmentMINOXIDILHairmax International, LLC7ee426fe-7a13-4327-b333-9651d6871a732026-04-30WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use only. For use by men only. Flammable: Keep away from fire or flame Do not use if: • 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. 5% minoxidil topical solution 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 heart disease 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. 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 May be harmful if used when pregnant or breast-feeding. Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away.

Additional Listing Data#

Finished product
Yes
Brand name base
Mens Extra Strength Minoxidil Hair Growth Treatment
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5965120SH1
Rxcui311724

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87616-969-00Mens Extra Strength Minoxidil Hair Growth Treatment60 mL in 1 BOTTLE, DROPPERSOLUTION602
87616-969-00Mens Extra Strength Minoxidil Hair Growth Treatment1 in 1 BOXSOLUTION12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311724minoxidil 5 % Topical SolutionPSN7ee426fe-7a13-4327-b333-9651d6871a732
311724minoxidil 50 MG/ML Topical SolutionSCD7ee426fe-7a13-4327-b333-9651d6871a732
311724minoxidil 3 GM per 60 ML Topical SolutionSY7ee426fe-7a13-4327-b333-9651d6871a732
311724minoxidil 5 % Topical SolutionSY7ee426fe-7a13-4327-b333-9651d6871a732
311724minoxidil 5 GM per 100 ML Topical SolutionSY7ee426fe-7a13-4327-b333-9651d6871a732

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
87616-969-00876160969001 BOTTLE, DROPPER in 1 BOX (87616-969-00) / 60 mL in 1 BOTTLE, DROPPER2026-03-09NoNoCurrent