Etaderm Mens Minoxidil Hair Regrowth Treatment Extra Strength

Product NDC
84180-878
11-digit product format
841800878
Labeler code
84180
Product ID
84180-878_3ed50d28-29c8-782c-e063-6394a90a2e39
Type
HUMAN OTC DRUG
Nonproprietary name
MINOXIDIL
Dosage form
SOLUTION
Route
TOPICAL
Labeler
NUEPHASE LLC
Application
ANDA076239
Marketing category
ANDA
Marketing start
2025-08-29
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
Etaderm Mens Minoxidil Hair Regrowth Treatment Extra Strength
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
84180-878-00Etaderm Mens Minoxidil Hair Regrowth Treatment Extra Strength60 mL in 1 BOTTLE, DROPPERSOLUTION601
84180-878-00Etaderm Mens Minoxidil Hair Regrowth Treatment Extra Strength1 in 1 BOXSOLUTION11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311724minoxidil 5 % Topical SolutionPSNfb838abf-43bf-4f7d-af78-18b7145946f41
311724minoxidil 50 MG/ML Topical SolutionSCDfb838abf-43bf-4f7d-af78-18b7145946f41
311724minoxidil 3 GM per 60 ML Topical SolutionSYfb838abf-43bf-4f7d-af78-18b7145946f41
311724minoxidil 5 % Topical SolutionSYfb838abf-43bf-4f7d-af78-18b7145946f41
311724minoxidil 5 GM per 100 ML Topical SolutionSYfb838abf-43bf-4f7d-af78-18b7145946f41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
84180-878-00841800878001 BOTTLE, DROPPER in 1 BOX (84180-878-00) / 60 mL in 1 BOTTLE, DROPPER2025-08-29NoNoCurrent