FDA.reportPublic FDA data

OLIVITA Minoxidil

Product NDC
83818-031
11-digit product format
838180031
Labeler code
83818
Product ID
83818-031_4cf37b0b-bbb9-1d9c-e063-6294a90af818
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Shenzhen Xinxin Yunhai Technology Co., Ltd.
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-03-14
Substance
MINOXIDIL
Active strength
5 g/100mL
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
OLIVITA Minoxidil
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL5 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5965120SH1
Rxcui311724

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83818-031-01OLIVITA Minoxidil60 mL in 1 BOTTLESOLUTION601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311724minoxidil 5 % Topical SolutionPSN4cf37b0b-bbb8-1d9c-e063-6294a90af8181
311724minoxidil 50 MG/ML Topical SolutionSCD4cf37b0b-bbb8-1d9c-e063-6294a90af8181
311724minoxidil 3 GM per 60 ML Topical SolutionSY4cf37b0b-bbb8-1d9c-e063-6294a90af8181
311724minoxidil 5 % Topical SolutionSY4cf37b0b-bbb8-1d9c-e063-6294a90af8181
311724minoxidil 5 GM per 100 ML Topical SolutionSY4cf37b0b-bbb8-1d9c-e063-6294a90af8181

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83818-031-018381800310160 mL in 1 BOTTLE (83818-031-01) 60 ml2026-03-14NoNoHistorical