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 63 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl alcoholISOPROPYL ALCOHOLFamily Dollar (FAMILY WELLNESS)1a3a789d-8c51-4661-84fe-df80ed70e6f12025-10-03WarningsExact identifier
application number: M003
Equate Antibacterial Fresh Hand WipesBENZALKONIUM CHLORIDEWalmart, Inc.d2bc26d8-3e46-e479-e053-2995a90abc0a2025-10-01WarningsExact identifier
application number: M003
Equate Antibacterial Wipes FreshBENZALKONIUM CHLORIDEWalmart, Inc.21d86d5b-46ee-6ffd-e063-6394a90ab0e52025-10-01WarningsExact identifier
application number: M003
Equate Antibacterial Wipes CitrusBENZALKONIUM CHLORIDEWalmart, Inc.2450dc1b-0c89-c92a-e063-6394a90afe222025-10-01WarningsExact identifier
application number: M003
Equate Antibacterial Citrus Hand WipesBENZALKONIUM CHLORIDEWalmart, Inc.d2cb4c64-66fc-58e4-e053-2a95a90a7f662025-10-01WarningsExact identifier
application number: M003
Kroger Antibacterial Hand WipesBENZALKONIUM CHLORIDEThe Kroger Co.17e29138-8c1f-e3b1-e063-6294a90a5d482025-10-01WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLFamily Dollar (FAMILY WELLNESS)2f1c3e24-ea71-4634-9ec1-670349b43a502025-10-01WarningsExact identifier
application number: M003
Fresh Feels Hand Sanitizer MistFRESH FEELS HAND SANITIZER MISTZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD3ffda86b-6b1d-8f0d-e063-6394a90aafaf2025-09-30WarningsExact identifier
application number: M003
BIOPURE 50CT ANTI BACTERIAL HAND WIPESBENZALKONIUM CHLORIDEZhejiang Furuisen Spunlaced Nonwovens Co., Ltd.ee484505-3bb1-2989-e053-2995a90aea2b2025-09-30WarningsExact identifier
application number: M003
Xpect First Aid CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCLCintas Corporationf7112e5d-c8c4-42ad-8a65-24bfc32d4aea2025-09-30WarningsExact identifier
application number: M003
Xpect Antiseptic WipesANTISEPTIC CLEANSERCintas Corporation8f1fd933-965e-42ec-ab96-47cfe780f9632025-09-29WarningsExact identifier
application number: M003
EVR Alcohol Prep PadsISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.3ffba233-6106-f633-e063-6394a90a96fe2025-09-29WarningsExact identifier
application number: M003
ProHeal Alcohol Prep PadISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.3ffc0619-eb13-77af-e063-6394a90a2fd92025-09-29WarningsExact identifier
application number: M003
ProHeal BZK Antiseptic TowelettesBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd.3ffc3f34-086d-1d18-e063-6294a90a71bb2025-09-29WarningsExact identifier
application number: M003
First Aid Direct Alcohol WipeISOPROPYL ALCOHOLCintas Corporation6a71449e-9a97-4923-8ec1-b1deb45b57462025-09-29WarningsExact identifier
application number: M003
Northside Hospital Mothers Kit, Grey BackpackALCOHOL AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLc0868060e-d593-4cb2-b3d2-6c59d1ae5efc2025-09-29WarningsExact identifier
application number: M003
First Aid Direct Antiseptic WipeBENZALKONIUM CHLORIDECintas Corporationa23f3685-7213-4cc0-97b2-588fb12247922025-09-29WarningsExact identifier
application number: M003
Xpect Alcohol WipesALCOHOL WIPESCintas Corporation51185b9a-ed6b-4a49-b524-b3ff0d5c62902025-09-29WarningsExact identifier
application number: M003
Super-Stop BloodClotterBLOOD CLOTTERCintas Corpd910ee9b-187d-49a9-ab96-281730db25752025-09-26WarningsExact identifier
application number: M003
Hand Sanitizer plus HolderBENZALKONIUM CHLORIDEAocai Biotechnology Huizhou Co Ltd3fa738ce-0a04-fa11-e063-6294a90aba882025-09-25WarningsExact 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