FDA.reportPublic FDA data

Gentian Violet 1%

Product NDC
82645-917
11-digit product format
826450917
Labeler code
82645
Product ID
82645-917_5634adec-3709-bcdf-e063-6394a90ae5a2
Type
HUMAN OTC DRUG
Nonproprietary name
Gentian Violet 1%
Dosage form
LIQUID
Route
TOPICAL
Labeler
Pharma Nobis, LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-01-01
Marketing end
2029-02-01
Substance
GENTIAN VIOLET
Active strength
10 mg/mL
NDC exclude flag
No
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 1%

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GENTIAN VIOLET10 mg/mL

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
e42fa7d2-47ef-0e82-e053-2995a90a67c5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82645-917-91Gentian Violet 1%30 mL in 1 BOTTLE, PLASTICLIQUID302
82645-917-92Gentian Violet 1%59 mL in 1 BOTTLE, PLASTICLIQUID592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82645-917GENTIAN VIOLET 1% LIQUID [PHARMA NOBIS, LLC]2Current NDC, Legacy NDC, 2 package rows20231227_e42fa7d2-47ef-0e82-e053-2995a90a67c5.zip

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 66 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer CrayolaALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e6ec04a-902f-2abc-e063-6394a90a96872025-09-10WarningsExact identifier
application number: M003
Smart Care Assorted Hand Sanitizer Jurassic WorldALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e6f1449-8d21-8953-e063-6394a90a93ac2025-09-10WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer SquishmallowsALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e6f0540-5882-2692-e063-6294a90a2f472025-09-10WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Dragon FruitETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.3e7d57b2-04ab-2ffe-e063-6394a90af8322025-09-10WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Jasmine ShadeETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.3e7df19c-00aa-5f1d-e063-6294a90af15e2025-09-10WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Mango PapayaETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.3e7e9c95-791c-7b2e-e063-6294a90ac3652025-09-10WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLUnifirst First Aid Corporation5c303611-f2d6-417b-b269-bb0013398efb2025-09-09WarningsExact identifier
application number: M003
Medi-First Plus Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCLUnifirst First Aid Corporation57ea7f8a-26e2-367e-e053-2a91aa0a93e12025-09-09WarningsExact identifier
application number: M003
Medi-First Burn with LidocaineBENZALKONIUM CHLORIDE, LIDOCAINEUnifirst First Aid Corporationf2b7e1c4-6369-9efa-e053-2a95a90a82122025-09-09WarningsExact identifier
application number: M003
McKesson Antiseptic Hand SanitizerETHYL ALCOHOLMcKesson Medical-Surgicalcc95bae9-d8ef-41f8-e053-2995a90aadab2025-09-09WarningsExact identifier
application number: M003
ECOLAB Hand SanitizerETHYL ALCOHOL 66.5%ECOLAB Food Safety Specialties, Inc.4c430aff-7f88-5529-e054-00144ff8d46c2025-09-09WarningsExact identifier
application number: M003
ECOLAB AntisepticBENZALKONIUM CHLORIDEEcolab Food Safety Specialties, Inc.933860e7-5a1f-453a-e053-2995a90a49022025-09-09WarningsExact identifier
application number: M003
ECOLAB Burn CreamBENZAALKONIUM CHLORIDE, LIDOCAINE HCLECOLAB Food Safety Specialties, Inc.4b2a7da9-c0e9-61c5-e054-00144ff8d46c2025-09-09WarningsExact identifier
application number: M003
ECOLAB AntisepticBENZALKONIUM CHLORIDE 0.13%ECOLAB Food Safety and Specialties, Inc.4c982e7b-2489-151f-e054-00144ff88e882025-09-09WarningsExact identifier
application number: M003
Thompson AntisepticBENZALKONIUM CHLORIDEThompsonf537c81d-1fdc-3e0f-e053-2a95a90a6c2b2025-09-09WarningsExact identifier
application number: M003
MedlineBENZALKONIUM CHLORIDE, LIDOCAIN HYDROCHLORIDEMedline Industries, LPb0b5ff82-db36-7708-e053-2a95a90ad9bb2025-09-09WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Champagne AppleETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.3e6ad099-c770-064f-e063-6294a90a222d2025-09-09WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla CascadeETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.3e6aef24-f162-5549-e063-6294a90a30b82025-09-09WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Caramel CinnamonETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.3e6aef38-215c-defa-e063-6394a90a46a62025-09-09WarningsExact identifier
application number: M003
Smart Care Kids Hand Sanitizer CrayolaALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e44c28e-c6ed-52b4-e063-6394a90a9dd02025-09-08WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310481gentian violet 1 % Topical SolutionPSNe42fa7d2-47ef-0e82-e053-2995a90a67c52
310481gentian violet 10 MG/ML Topical SolutionSCDe42fa7d2-47ef-0e82-e053-2995a90a67c52
310481gentian violet 1 % Topical SolutionSYe42fa7d2-47ef-0e82-e053-2995a90a67c52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82645-917-918264509179130 mL in 1 BOTTLE, PLASTIC (82645-917-91) 30 ml2017-11-132028-04-01NoNoCurrent
82645-917-928264509179259 mL in 1 BOTTLE, PLASTIC (82645-917-92) 59 ml2017-11-132029-02-01NoNoCurrent