FDA.reportPublic FDA data

GROWELL Mens Hair Regrowth Treatment 5 Minoxidil

Product NDC
84329-465
11-digit product format
843290465
Labeler code
84329
Product ID
84329-465_18911e7d-a92e-7b65-e063-6294a90a9429
Type
HUMAN OTC DRUG
Nonproprietary name
MINOXIDIL
Dosage form
LIQUID
Route
TOPICAL
Labeler
APIRA SCIENCE, INC.
Application
ANDA076239
Marketing category
ANDA
Marketing start
2024-03-04
Substance
MINOXIDIL
Active strength
50 mg/mL
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
GROWELL Mens Hair Regrowth Treatment 5 Minoxidil
Listing expiration
2026-12-31

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
84329-465-00GROWELL Mens Hair Regrowth Treatment 5 Minoxidil60 mL in 1 BOTTLE, DROPPERLIQUID601
84329-465-00GROWELL Mens Hair Regrowth Treatment 5 Minoxidil1 in 1 BOXLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84329-465GROWELL MENS HAIR REGROWTH TREATMENT 5 MINOXIDIL (MINOXIDIL) LIQUID [APIRA SCIENCE, INC.]1Current NDC, 2 package rows20240517_8cd4a3a9-94ba-48c7-8516-b50504c2c440.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311724minoxidil 5 % Topical SolutionPSN8cd4a3a9-94ba-48c7-8516-b50504c2c4401
311724minoxidil 50 MG/ML Topical SolutionSCD8cd4a3a9-94ba-48c7-8516-b50504c2c4401
311724minoxidil 3 GM per 60 ML Topical SolutionSY8cd4a3a9-94ba-48c7-8516-b50504c2c4401
311724minoxidil 5 % Topical SolutionSY8cd4a3a9-94ba-48c7-8516-b50504c2c4401
311724minoxidil 5 GM per 100 ML Topical SolutionSY8cd4a3a9-94ba-48c7-8516-b50504c2c4401

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
84329-465-00843290465001 BOTTLE, DROPPER in 1 BOX (84329-465-00) / 60 mL in 1 BOTTLE, DROPPER2024-03-04NoNoHistorical