5% MINOXIDIL HAIR REGROWTH SERUM With Biotin

Product NDC
84614-001
11-digit product format
846140001
Labeler code
84614
Product ID
84614-001_3e97f3b5-fc6a-bf6a-e063-6394a90aebc1
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Shenzhen Ctrip Technology Co., Ltd.
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-08-02
Substance
BIOTIN; MINOXIDIL
Active strength
.2; 5 g/100mL; g/100mL
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
5% MINOXIDIL HAIR REGROWTH SERUM With Biotin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BIOTIN.2 g/100mL
MINOXIDIL5 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6SO6U10H04, 5965120SH1

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84614-001-015% MINOXIDIL HAIR REGROWTH SERUM With Biotin60 mL in 1 BOTTLESOLUTION602
84614-001-015% MINOXIDIL HAIR REGROWTH SERUM With Biotin2 in 1 PACKAGESOLUTION22
84614-001-025% MINOXIDIL HAIR REGROWTH SERUM With Biotin4 in 1 PACKAGESOLUTION42
84614-001-025% MINOXIDIL HAIR REGROWTH SERUM With Biotin60 mL in 1 BOTTLESOLUTION602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84614-0015% MINOXIDIL HAIR REGROWTH SERUM WITH BIOTIN (MINOXIDIL) SOLUTION [SHENZHEN CTRIP TECHNOLOGY CO., LTD.]1Current NDC, 4 package rows20240805_1eae27bc-1b18-ae5d-e063-6394a90a4610.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84614-001-01846140001012 BOTTLE in 1 PACKAGE (84614-001-01) / 60 mL in 1 BOTTLE2 bottle2024-08-02NoNoHistorical
84614-001-02846140001024 BOTTLE in 1 PACKAGE (84614-001-02) / 60 mL in 1 BOTTLE4 bottle2024-08-02NoNoHistorical