Colorsmith Hair Regrowth Treatment Mens Minoxidil Topical Solution Extra Strength

Product NDC
84856-603
11-digit product format
848560603
Labeler code
84856
Product ID
84856-603_262a7fae-86ee-a9c7-e063-6394a90a1fe8
Type
HUMAN OTC DRUG
Nonproprietary name
MINOXIDIL
Dosage form
SOLUTION
Route
TOPICAL
Labeler
ESALON.COM, LLC
Application
ANDA076239
Marketing category
ANDA
Marketing start
2024-10-16
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
Colorsmith Hair Regrowth Treatment Mens Minoxidil Topical Solution 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
84856-603-00Colorsmith Hair Regrowth Treatment Mens Minoxidil Topical Solution Extra Strength60 mL in 1 BOTTLE, DROPPERSOLUTION601
84856-603-00Colorsmith Hair Regrowth Treatment Mens Minoxidil Topical Solution Extra Strength1 in 1 BOXSOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84856-603COLORSMITH HAIR REGROWTH TREATMENT MENS MINOXIDIL TOPICAL SOLUTION EXTRA STRENGTH (MINOXIDIL) SOLUTION [ESALON.COM, LLC]1Current NDC, 2 package rows20241106_69b01eab-df9f-4ae8-87e4-add18883874b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311724minoxidil 5 % Topical SolutionPSN69b01eab-df9f-4ae8-87e4-add18883874b1
311724minoxidil 50 MG/ML Topical SolutionSCD69b01eab-df9f-4ae8-87e4-add18883874b1
311724minoxidil 3 GM per 60 ML Topical SolutionSY69b01eab-df9f-4ae8-87e4-add18883874b1
311724minoxidil 5 % Topical SolutionSY69b01eab-df9f-4ae8-87e4-add18883874b1
311724minoxidil 5 GM per 100 ML Topical SolutionSY69b01eab-df9f-4ae8-87e4-add18883874b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
84856-603-00848560603001 BOTTLE, DROPPER in 1 BOX (84856-603-00) / 60 mL in 1 BOTTLE, DROPPER2024-10-16NoNoCurrent