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 37 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer Citrus SunsetALCOHOLShenzhen Lantern Scicence Co.,Ltd.49f67a60-a6d8-0aa4-e063-6394a90a98592026-02-03WarningsExact identifier
application number: M003
WIPES4HEALTHBENZALKONIUM CHLORIDEBubble Marketing LLC5d6dd15b-d087-4f25-bd2b-035ecacd5f972026-02-03WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLConcordance Healthcare Solutions, LLC1c051d6a-61a8-4a75-aeb6-7c1258bda2b22026-02-02Warnings, Adverse reactionsExact identifier
application number: M003
Dealmed Sterile Alcohol Prep Pads LargeISOPROPYL ALCOHOLDealmed Medical Supplies, LLC.75908e89-abd9-4760-bd11-fb71133ae2c02026-02-02WarningsExact identifier
application number: M003
Dealmed Sterile Alcohol Prep Pads MediumISOPROPYL ALCOHOLDealmed Medical Supplies, LLC.0cdfc6b4-7d66-4333-b38d-c465d4864b5c2026-02-02WarningsExact identifier
application number: M003
MedlinePOVIDONE-IODINEMedline Industries, LP494d7e97-a3a8-2c7a-e063-6394a90a3ae12026-02-02WarningsExact identifier
application number: M003
AplicareISOPROPYL ALCOHOLAplicare Products, LLC4950e07f-36a5-b6f5-e063-6294a90a8f982026-02-02WarningsExact identifier
application number: M003
RELEEV Cold Sore TreatmentBENZALKONIUM CHLORIDEMerix Pharmaceutical Corp.fcef2fd3-2f32-4fb0-b396-ba4481ca4ccf2026-02-02WarningsExact identifier
application number: M003
WISH RUBBING ALCOHOL 91%ISOPROPYL ALCOHOLLJ Pharma07cba887-a568-4b92-91ab-2e7831f24ab52026-01-30WarningsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINERite Aid Corporation2f8abb6f-460f-47bf-811d-734126aa3f0b2026-01-30Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLRite Aid Corporationc074bbaf-2fd7-485a-9e22-a368d8dd47012026-01-30Warnings, Adverse reactionsExact identifier
application number: M003
Drs. pharmacy triple antibiotic plus lidocaineBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, LIDOCAINE OINTMENTOL PHARMA TECH, LLC49a73b0f-90d9-3a4b-e063-6294a90acfb02026-01-30WarningsExact identifier
application number: M003
HAND SANITIZER WIPESHAND SANITIZER WIPESShandong Baihe Sanitary Products Co., Ltd.49822c99-1181-ae42-e063-6394a90a82022026-01-29WarningsExact identifier
application number: M003
WISH RUBBING ALCOHOL 50%ISOPROPYL ALCOHOLLJ Pharma15b4a45d-3dbf-48e4-8f90-15dca7e650d92026-01-29WarningsExact identifier
application number: M003
WISH RUBBING ALCOHOL 50% Winter GreenISOPROPYL ALCOHOLLJ Pharmafbb45bde-b733-4524-bfa9-ae819ad399732026-01-29WarningsExact identifier
application number: M003
WalmartISOPROPYL ALCOHOLWalmart Inc.1d75799d-081e-a38b-e063-6294a90adf352026-01-29WarningsExact identifier
application number: M003
Liquid BandageBENZETHONIUM CHLORIDE AND DYCLONINE HYDROCHLORIDEWal-Mart Stores, Inc.f3911d79-3169-71c3-e053-2a95a90ae8432026-01-29WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEAmerifoods Trading Co38b15693-7e5f-4c85-915e-9937ea018a832026-01-29Warnings, Adverse reactionsExact identifier
application number: M003
IRISISOPROPYL ALCOHOLAmerifoods Trading Co100e0c3d-96eb-44af-8684-df45a8ab30652026-01-29Warnings, Adverse reactionsExact identifier
application number: M003
First Aid AntisepticFIRST AID ANTISEPTICAmerisource Bergen6719db46-a6e3-4f0a-828c-fe89a51879892026-01-29Warnings, Adverse reactionsExact 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