Gainxtra Hair Regrowth Treatment for Men and Women Minoxidil 5% Form with Biotin

Product NDC
85929-101
11-digit product format
859290101
Labeler code
85929
Product ID
85929-101_43368b92-732b-68c6-e063-6294a90acd88
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
GAINXTRA LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-07
Substance
MINOXIDIL
Active strength
50 mg/g
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
5965120SH1MINOXIDIL38304-91-5MINOXIDIL

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85929-101-18859290101183 CAN in 1 BOX (85929-101-18) / 60 g in 1 CAN3 can2025-11-07NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Gainxtra Hair Regrowth Treatment for Men and Women Minoxidil 5% Form with BiotinGAINXTRA LLC2025-11-10HUMAN OTC DRUG LABEL1