AGIKENB 5% minoxidil with biotin topical solution

Product NDC
85304-029
11-digit product format
853040029
Labeler code
85304
Product ID
85304-029_4dc2be0b-59f2-50fd-e063-6294a90a6f54
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Guangzhou Borderless Technology Co., Ltd.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-03-24
Substance
BIOTIN; MINOXIDIL
Active strength
.005; .05 g/mL; g/mL
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AGIKENB 5% minoxidil with biotin topical solution
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BIOTIN.005 g/mL
MINOXIDIL.05 g/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6SO6U10H04, 5965120SH1
Rxcui2715603

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85304-029-01AGIKENB 5% minoxidil with biotin topical solution4 in 1 PACKAGESOLUTION41
85304-029-01AGIKENB 5% minoxidil with biotin topical solution60 mL in 1 BOTTLESOLUTION601
85304-029-02AGIKENB 5% minoxidil with biotin topical solution8 in 1 PACKAGESOLUTION81
85304-029-02AGIKENB 5% minoxidil with biotin topical solution60 mL in 1 BOTTLESOLUTION601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2715603biotin 0.5 % / minoxidil 5 % Topical SprayPSN4dc2be0b-59f1-50fd-e063-6294a90a6f541
2715603biotin 5 MG/ML / minoxidil 50 MG/ML Topical SpraySCD4dc2be0b-59f1-50fd-e063-6294a90a6f541
2715603biotin 0.5 % / minoxidil 5 % Topical SpraySY4dc2be0b-59f1-50fd-e063-6294a90a6f541

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85304-029-01853040029014 BOTTLE in 1 PACKAGE (85304-029-01) / 60 mL in 1 BOTTLE4 bottle2026-03-24NoNoHistorical
85304-029-02853040029028 BOTTLE in 1 PACKAGE (85304-029-02) / 60 mL in 1 BOTTLE8 bottle2026-03-24NoNoHistorical