FDA.reportPublic FDA data

Gentian Violet

Product NDC
10095-101
11-digit product format
100950101
Labeler code
10095
Product ID
10095-101_419cc9a2-bfdf-a516-e063-6294a90a065c
Type
HUMAN OTC DRUG
Nonproprietary name
Gentian Violet
Dosage form
SOLUTION
Route
TOPICAL
Labeler
World Perfumes Inc
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-01
Substance
GENTIAN VIOLET
Active strength
1 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Gentian Violet
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GENTIAN VIOLET1 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
J4Z741D6O5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310481Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
419cc9a2-bfde-a516-e063-6294a90a065cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10095-101-02Gentian Violet30 mL in 1 BOTTLE, WITH APPLICATORSOLUTION301

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 111 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DermaWound Wound CarePOVIDONE-IODINEProgressive Doctors, LLC2d49daa7-aa02-4219-880b-e1697bde8a7e2023-12-15WarningsExact identifier
application number: M003
Ethyl Rubbing AlcoholALCOHOLHumco Holding Group, Inc.829f3e16-7a9b-4da7-87d2-f58254bda7212023-12-15WarningsExact identifier
application number: M003
Humco Iodides TinctureETHYL ALCOHOLHumco Holding Group, Inc.d230e3a2-1cde-44a9-82c3-3dc5474b3a722023-12-15WarningsExact identifier
application number: M003
Humco Hydrogen PeroxideHYDROGEN PEROXIDE 3%Humco Holding Group, Inc.2fdd3aa0-e45e-46bb-aa01-88e59d8afbfd2023-12-15WarningsExact identifier
application number: M003
HUMCO Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLHumco Holding Group, Inc.c220b916-6914-435f-84e2-ba828c9916b12023-12-15WarningsExact identifier
application number: M003
HUMCO Isopropyl Rubbing Alcohol 70% Professional PackISOPROPYL ALCOHOLHumco Holding Group, Inc.8de61fdd-8bb9-4845-9129-97bed0686a682023-12-15WarningsExact identifier
application number: M003
HUMCO MerthiolateBENZALKONIUM CHLORIDEHumco Holding Group, Inc.864063a5-c6cc-4657-9cd6-51af4673bf982023-12-15WarningsExact identifier
application number: M003
Povidone IodinePOVIDONE-IODINE SPRAY 5%Humco Holding Group, Inc.a7bb80c4-bbc0-21ea-e053-2995a90a52c12023-12-15WarningsExact identifier
application number: M003
Povidone IodinePOVIDONE IODINE 10%Humco Holding Group, Inc.6064c23b-7c15-208d-e053-2991aa0a00f62023-12-15WarningsExact identifier
application number: M003
Povidone IodinePOVIDONE IODINE GARGLE 0.5%Humco Holding Group, Inc.a7b9ad55-cfeb-6066-e053-2a95a90af9752023-12-15WarningsExact identifier
application number: M003
Rite Aid Povidone IodinePOVIDONE IODINE 10%Rite Aid Corporation5df6ff37-a4ea-d666-e053-2991aa0a97862023-12-15WarningsExact identifier
application number: M003
Rite Aid Decolorized IodineETHYL ALCOHOLRite Aid Corporation5e0d3664-b02a-ba28-e053-2991aa0a8a4c2023-12-15WarningsExact identifier
application number: M003
De La Cruz Tincture of IodineIODINE AND SODIUM IODIDE AND ALCOHOLDLC Laboratories, Inc.5d8f60a9-6d1c-0b0f-e053-2991aa0a8a9b2023-12-15WarningsExact identifier
application number: M003
ALCOHOL ANTISEPTIC HAND SANITIZER ANTIBACTERIALALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.0c73f4f5-2b1d-84ae-e063-6394a90a5d7b2023-12-14WarningsExact identifier
application number: M003
TaeTu AftercareBENZALKONIUM CHLORIDETaetu LLCdec15a4d-1a33-a78a-e053-2995a90a69fe2023-12-14WarningsExact identifier
application number: M003
GNP Idoinde Tincture 2% MildIODINE AND SODIUM IODIDE AND ALCOHOLAmerisource Bergen32ad75b8-abd1-4151-a035-b6c9ae5fc8882023-12-14WarningsExact identifier
application number: M003
Antibacterial Wet WipesBENZALKONIUM CHLORIDEHangZhou YangYi Daily Cosmetics Technology Co., Ltd.85d3914d-dbb8-5036-e053-2a91aa0a7cd42023-12-13WarningsExact identifier
application number: M003
AntiochPharma Rapidgel Hand SanitizerALCOHOLWeeks & Leo0c57a9ea-de66-3ced-e063-6294a90a4b8d2023-12-12WarningsExact identifier
application number: M003
antiseptic hand sanitizer 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.e9f9b7b6-fed7-10e1-e053-2a95a90a9aa62023-12-11WarningsExact identifier
application number: M003
AntiochPharma Hand SanitizerALCOHOLWeeks & Leoa1a0d368-b004-59b8-e053-2995a90ab4b12023-12-11WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310481gentian violet 1 % Topical SolutionPSN419cc9a2-bfde-a516-e063-6294a90a065c1
310481gentian violet 10 MG/ML Topical SolutionSCD419cc9a2-bfde-a516-e063-6294a90a065c1
310481gentian violet 1 % Topical SolutionSY419cc9a2-bfde-a516-e063-6294a90a065c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10095-101-021009501010230 mL in 1 BOTTLE, WITH APPLICATOR (10095-101-02) 30 ml2025-10-01NoNoCurrent