SOTI HAIR GROWTH SERUM

Product NDC
81653-013
11-digit product format
816530013
Labeler code
81653
Product ID
81653-013_529d33c1-574b-29bc-e063-6294a90a3474
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
LIQUID
Route
TOPICAL
Labeler
Guangzhou Jianyuan Biological Technology Co., Ltd.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-04
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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SOTI HAIR GROWTH SERUMMINOXIDILGuangzhou Jianyuan Biological Technology Co., Ltd.0d8beb7c-48be-54de-e063-6394a90a41492026-05-24WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use only Flammable: Keep away from fire or flame Do not use if ■ our amount of hair loss is different than that shown the side of this carton or your hair loss is on the front of the scalp. Hair Growth Serum is not intended for frontal baldness or receding hairline ■ you have no family history of hair loss ■ your hair loss is sudden and/or patch ■ you do not know the reason for your hair loss ■ you are under 18 years of age. Do not use on babies and children ■ your scalp is red, inflamed, infected, irritated, or painful ■ you use other medicines on the scalp Ask a doctor before use if you have heart disease When using this product ■ do not apply on other parts of the body ■ avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water ■ some people have experienced changes in hair color and or texture ■ it takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some people, you may need to use this product for at least 4 months before you see results. ■ the amount of hair regrowth is different for each person. This product will not work for all people Stop use and ask a doctor if ■ chest pain, rapid heartbeat, faintness, or dizziness occurs ■ sudden, unexplained weight gain occurs ■ your hands or feet swell ■ scalp irritation or redness occurs ■ unwanted facial hair growth occurs ■ you do not see hair regrowth in 4 months May be harmful if used when pregnant or breast-feeding Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center right away.

Additional Listing Data#

Finished product
Yes
Brand name base
SOTI HAIR GROWTH SERUM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL5 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5965120SH1
Rxcui311724

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81653-013-012025-02-09C16284748780-12cef2736-9525-d83d-e063-dadaa90ab31f81653-013 Update 505G
81653-013-012025-01-30C16284748780-12cef2736-9525-d83d-e063-dadaa90ab31f81653-013 Update 505G

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81653-013-01SOTI HAIR GROWTH SERUM60 mL in 1 BOTTLELIQUID604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81653-013SOTI HAIR GROWTH SERUM (MINOXIDIL) LIQUID [GUANGZHOU JIANYUAN BIOLOGICAL TECHNOLOGY CO., LTD.]3Current NDC, 1 package rows20250212_0d8beb7c-48be-54de-e063-6394a90a4149.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311724minoxidil 5 % Topical SolutionPSN0d8beb7c-48be-54de-e063-6394a90a41494
311724minoxidil 50 MG/ML Topical SolutionSCD0d8beb7c-48be-54de-e063-6394a90a41494
311724minoxidil 3 GM per 60 ML Topical SolutionSY0d8beb7c-48be-54de-e063-6394a90a41494
311724minoxidil 5 % Topical SolutionSY0d8beb7c-48be-54de-e063-6394a90a41494
311724minoxidil 5 GM per 100 ML Topical SolutionSY0d8beb7c-48be-54de-e063-6394a90a41494

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81653-013-018165300130160 mL in 1 BOTTLE (81653-013-01) 60 ml2023-12-04NoNoCurrent