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 102 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
STRAWBERRY SHORTCAKE SCENTED HAND SANITIZERALCOHOLGanzhou Olivee Cosmetic Co., Ltd.997d0ff0-96b4-4b91-87fc-8f67d9b5013c2024-08-28WarningsExact identifier
application number: M003
hand sanitizer 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.202dfeac-6e69-8667-e063-6294a90a26d22024-08-21WarningsExact identifier
application number: M003
antibacterial hand sanitizer gel 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.202e5c15-8749-0a76-e063-6294a90a27202024-08-21WarningsExact identifier
application number: M003
Be Smart Get Prepared Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE ANHYDROUSTotal Resources International, Inceacb5138-4af8-4550-b883-5603ad96ed7d2024-08-16WarningsExact identifier
application number: M003
First Aid Only Povidone-Iodine AntisepticPOVIDONE-IODINEAcme United Corporatione0052ac2-4f74-32a4-e053-2995a90a94c62024-08-13WarningsExact identifier
application number: M003
Keep Going Sting Relief PadBENZOCAINE AND ISOPROPYL ALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.36c11178-b70f-4355-8823-c2b72598dae52024-08-08WarningsExact identifier
application number: M003
Keep Going Non Sting Cleaning WipeBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.6b7400d5-d4b8-4b68-b048-c1917cdf3ce32024-08-08WarningsExact identifier
application number: M003
Keep Going Alcohol Prep PadISOPROPYL ALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.f67dd10c-746f-4c21-92f1-741f86218a692024-08-08WarningsExact identifier
application number: M003
Sugar Cookie Sanitizer 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1efc0e9e-b4eb-d2b0-e063-6394a90a77792024-08-06WarningsExact identifier
application number: M003
Lemon Lime Hand Sanitizer Spray. 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1efe7236-d7bd-2a1c-e063-6294a90a736e2024-08-06WarningsExact identifier
application number: M003
Maokang Medical 10 Povidone IodinePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd644e92c3-3043-4a76-9845-7e0482cf9f622024-07-19WarningsExact identifier
application number: M003
Dermal Wound CleanserBENZETHONIUM CHLORIDESmith & Nephew Medical Ltd.18704cd5-1ecf-4e8c-9897-7e45394e68c82024-07-15WarningsExact identifier
application number: M003
Novex Anti-Bacterial Hand Sanitizer WipeBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.7832a0be-a8ce-4b56-a9bb-a375b97df2872024-07-10WarningsExact identifier
application number: M003
Callington Anti-Bacterial Hand Sanitizer WipeBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.00ca48ca-893d-4a3f-ad90-119522664e082024-07-10WarningsExact identifier
application number: M003
Assorted Licensed Hand Sanitizer Grape 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1c9095ad-ce19-3666-e063-6394a90ae22d2024-07-09WarningsExact identifier
application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER FRESH CITRUSETHYL ALCOHOLMY IMPORTS USA LLC1ccb78ed-36f9-a7d2-e063-6394a90a64772024-07-09WarningsExact identifier
application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER LAVENDERETHYL ALCOHOLMY IMPORTS USA LLC1ccb9671-1970-39f9-e063-6294a90ac0792024-07-09WarningsExact identifier
application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER STRAWBERRYETHYL ALCOHOLMY IMPORTS USA LLC1ccbc68e-2b6b-768c-e063-6294a90a643b2024-07-09WarningsExact identifier
application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER ORIGINALETHYL ALCOHOLMY IMPORTS USA LLC1ccbbc55-3f7d-76d1-e063-6294a90a55902024-07-09WarningsExact identifier
application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER LAVENDERETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.1cb701f7-61c8-e5f4-e063-6294a90a0c3c2024-07-08WarningsExact 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