FDA.reportPublic FDA data

Hair Regrowth Treatment

Manufacturer
Dongguan yiyu trading co., ltd
Effective date
2025-03-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:57:42

Label at a glance#

ProductHair Regrowth Treatment
Active ingredientMINOXIDIL
Label structure12 sections

Dosage and administration

1. Massage the scalp to completely relax the scalp. 2. Apply one or two drops to the scalp area to be used. 3. Apply evenly to the rest of the area. 4. Use twice a day.

Storage and handling

Store at controlled room temperature 20° to25°C (68° to 77*F).

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

minoxidil 5%

Purpose

OTC - PURPOSE SECTION

Hair Begrowth Treatment

Use

INDICATIONS & USAGE SECTION

To regrow hair on the top of the scalp

Warnings

WARNINGS SECTION

For external use only.Flammable. Keep away from heat or flame.

Do not use

OTC - DO NOT USE SECTION

●in children less than 2 months of age
●on open skin wounds

OTC - WHEN USING SECTION

●When using this product keep out of eyes, ears, and mouth. in case of contact with eyes, rinse eyes thoroughly with water
●Stop use and ask a doctor if iritation or rash occurs, These may be signs of a serious condition.
●Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor iritation or rash occurs, These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

1. Massage the scalp to completely relax the scalp.
2. Apply one or two drops to the scalp area to be used.
3. Apply evenly to the rest of the area.
4. Use twice a day.

Other information

STORAGE AND HANDLING SECTION

Store at controlled room temperature 20° to25°C (68° to 77*F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Butanediol,Platycladus orientalis leaf extract,Ginger root extract, Polygonum
multiflorum extract, Tobacco extract,lemon extract,Sweet orange extract, Turmeric
extract,vigna radiata,red clover phenoxyaethanolum

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311724minoxidil 5 % Topical SolutionPSN2
311724minoxidil 50 MG/ML Topical SolutionSCD2
311724minoxidil 3 GM per 60 ML Topical SolutionSY2
311724minoxidil 5 % Topical SolutionSY2
311724minoxidil 5 GM per 100 ML Topical SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MINOXIDIL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85407-001-01Hair Regrowth Treatment100 mL in 1 BOTTLELIQUID1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85407-001HAIR REGROWTH TREATMENT LIQUID [DONGGUAN YIYU TRADING CO., LTD]21 package rows20250326_30d0e538-963e-2aa5-e063-6394a90ae742.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85407-00185407-001-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
MUNG BEAN1LIB31N73GIACT
WATER059QF0KO0RIACT
BUTANEDIOL (MIXED ISOMERS)TMS4MGA0H4IACT
PLATYCLADUS ORIENTALIS LEAF32E5V7G32BIACT
GINGERC5529G5JPQIACT
RHEINYM64C2P6UXIACT
TOBACCO LEAF6YR2608RSUIACT
LEMON24RS0A988OIACT
ORANGE TERPENES9J3RG7FX7SIACT
CURCUMINIT942ZTH98IACT
MINOXIDIL5965120SH1ACTIB
RED CLOVERL9153EKV2YIACT
PHENOXYETHANOLHIE492ZZ3TIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
310cc524-7b0b-7a14-e063-6294a90af19230d0e538-963e-2aa5-e063-6394a90ae7422025-03-23WarningsExact identifier
spl id: 310cc524-7b0b-7a14-e063-6294a90af192
spl set id: 30d0e538-963e-2aa5-e063-6394a90ae742

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.