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 46 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer Coconut BreezeALCOHOLShenzhen Lantern Scicence Co.,Ltd.47af27a7-3df9-270a-e063-6394a90abc7d2026-01-05WarningsExact identifier
application number: M003
Hand SanitiserALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.a44d82bf-68a3-56bc-e053-2995a90ae5262026-01-05WarningsExact identifier
application number: M003
Green Island SanitiserALCOHOLZhejiang Guoyao Aerosol Co., Ltda7d1df16-3566-badf-e053-2a95a90aa61a2026-01-05WarningsExact identifier
application number: M003
Green IslandETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.a7443a72-6ee5-07f7-e053-2995a90a33412026-01-05WarningsExact identifier
application number: M003
SHABOINKETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.a8bc5da3-8660-6343-e053-2995a90ac9052026-01-05WarningsExact identifier
application number: M003
SHABOINKETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.a8c0c9ce-05ac-0f33-e053-2a95a90ab8ed2026-01-05WarningsExact identifier
application number: M003
H2OneETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.a9bcecf7-7767-69b4-e053-2995a90a92472026-01-05WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer MermicornoALCOHOLShenzhen Lantern Scicence Co.,Ltd.47af97d6-ae84-adfe-e063-6394a90aa7772026-01-05WarningsExact identifier
application number: M003
Healing SolutionsETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.a9bf73d9-9eb2-5e12-e053-2995a90a03322026-01-05WarningsExact identifier
application number: M003
PFAETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.bc91087d-5976-e922-e053-2995a90ae2ac2026-01-05WarningsExact identifier
application number: M003
American Red Cross 70% Ethyl Alcohol Hand SanitizerETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltdf6bf5c5a-4954-4030-e053-6394a90a9cba2026-01-05WarningsExact identifier
application number: M003
Hand sanitizer 8oz with vitamin EETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.03f88721-92a5-1453-e063-6294a90a15912026-01-05WarningsExact identifier
application number: M003
Hand sanitizer 16.9oz with vitamin EETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.04064c4d-e810-28ff-e063-6394a90a39832026-01-05WarningsExact identifier
application number: M003
Hand sanitizer 8oz with aloe veraETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.04064b0b-6f21-9ca4-e063-6294a90a85e22026-01-05WarningsExact identifier
application number: M003
Hand sanitizer 2oz 2pk lavenderETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.05204974-88f3-84ce-e063-6394a90a326b2026-01-05WarningsExact identifier
application number: M003
Hand sanitizer 2oz 2pk with aloe veraETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.04fe378d-ee1e-ad52-e063-6294a90ae1462026-01-05WarningsExact identifier
application number: M003
Hand sanitizer 2oz 2pk lemonETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.04fe16d8-1824-34fe-e063-6394a90a7ab12026-01-05WarningsExact identifier
application number: M003
Hand sanitizer 16.9oz with vitamin EETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.0fbc45c1-c7e8-bded-e063-6394a90a31d12026-01-05WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Monster JamALCOHOLShenzhen Lantern Scicence Co.,Ltd.47afe5bd-5e06-7300-e063-6294a90a94e82026-01-05WarningsExact identifier
application number: M003
Walgreens Hand Sanitizer watermelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.479b898c-0dff-98fe-e063-6294a90ade202026-01-04WarningsExact 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