FDA.reportPublic FDA data

Anagen Topical Solution

Manufacturer
ANAGEN INNOVATION MEDICINE LTD
Effective date
2025-04-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:59:17

Label at a glance#

ProductAnagen Topical Solution
Active ingredientRU-58841
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ru-58841 5%

OTC - PURPOSE SECTION

Hair Regrowth Treatment

INDICATIONS & USAGE SECTION

Hair Regrowth Treatment
For Research Purpose OnlyNot For Human Consumption

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN SECTION

WARNINGS SECTION

For external use only

DOSAGE & ADMINISTRATION SECTION

Take an appropriate amount of solution and apply it to the root of the head

INACTIVE INGREDIENT SECTION

GLYCERIN
ALCOHOL
LEVOMENTHOL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label2label2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85475-002-01Anagen Topical Solution60 mL in 1 BOTTLESOLUTION603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85475-002ANAGEN TOPICAL SOLUTION (RU-58841 8%) SOLUTION [ANAGEN INNOVATION MEDICINE LTD]31 package rows20250418_31dc62c6-ea76-7e45-e063-6394a90a93f1.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85475-00285475-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID2968PHW8QPIACT
LACTIC ACID33X04XA5ATIACT
RU-588410D8FJQ0ADWACTIB
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MIACT
MENTHOLL7T10EIP3AIACT
WATER059QF0KO0RIACT

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
32f4ba67-0f38-494d-e063-6294a90a1fb431dc62c6-ea76-7e45-e063-6394a90a93f12025-04-17WarningsExact identifier
spl id: 32f4ba67-0f38-494d-e063-6294a90a1fb4
spl set id: 31dc62c6-ea76-7e45-e063-6394a90a93f1

Reported adverse events (FAERS/openFDA)#

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