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 20 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer with Beaded Wristlet Vanilla BlossomALCOHOLShenzhen Lantern Scicence Co.,Ltd.5227736d-c13b-652b-e063-6394a90adc6b2026-05-19WarningsExact identifier
application number: M003
CVS Isopropyl Rubbing Alcohol WipesISOPROPYL ALCOHOLCVS PHARMACY, INC7e027210-9729-4659-8a75-b6b2ac60f7bc2026-05-19WarningsExact identifier
application number: M003
CVS Isopropyl Rubbing Alcohol PadsISOPROPYL ALCOHOLCVS PHARMACY, INCe65b3363-71d9-47b6-a044-edac18f9858f2026-05-19WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer with Beaded Wristlet Lily WaterALCOHOLShenzhen Lantern Scicence Co.,Ltd.523a8084-a67b-77da-e063-6394a90a4ff92026-05-19WarningsExact identifier
application number: M003
Caring Mill BZK TowelettesBENZALKONIUM CHLORIDEFSA Store Inc.51f20e04-3efb-9dbf-e063-6394a90a4aca2026-05-18WarningsExact identifier
application number: M003
Meijer Hand Sanitizer Fall Harvest AppleALCOHOLShenzhen Lantern Scicence Co.,Ltd.5213f632-33a0-aa45-e063-6294a90a71a02026-05-18WarningsExact identifier
application number: M003
Meijer Hand Sanitizer Fall Harvest Pumpkin SpiceALCOHOLShenzhen Lantern Scicence Co.,Ltd.522413eb-d7e3-65ea-e063-6394a90a942b2026-05-18WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer with Beaded Wristlet RosewateALCOHOLShenzhen Lantern Scicence Co.,Ltd.52245438-751b-b52e-e063-6394a90aeb472026-05-18WarningsExact identifier
application number: M003
KOOL AID HAND SANITIZER TROPICAL PUNCHALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5208adea-27d8-81a3-e063-6294a90afc802026-05-17WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLGuangdong Yanze Biotechnology Co., Ltd.520e7b2b-e24e-5ce7-e063-6294a90a986d2026-05-17WarningsExact identifier
application number: M003
Wish Alcohol PadISOPROPYL ALCOHOL CLOTHYiwu Ori-Power Medtech Co.,Ltd.51f87ed7-04ae-136a-e063-6294a90a95002026-05-16WarningsExact identifier
application number: M003
Verifine Alcohol SwabsALCOHOL SWABSPromisemed Hangzhou Meditech Co.,LTD.4e91983f-4570-3a56-e063-6394a90a38f22026-05-15WarningsExact identifier
application number: M003
Swab Applicator Brushe7.5% w/w Povidone-Iodine (PVP)POVIDONE-IODINEXINXIANG XINDA TECHNOLOGY CO.,LTD51c29301-978a-0d46-e063-6394a90ab9e42026-05-14WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLChain Drug Marketing Associationf5b99c4b-1f4b-40be-bae7-59aa92c5b52c2026-05-14Warnings, Adverse reactionsExact identifier
application number: M003
91% Isopropyl AlcoholISOPROPYL ALCOHOLChain Drug Marketing Associationf10995fd-fe94-436a-8783-4cdf10438d752026-05-14Warnings, Adverse reactionsExact identifier
application number: M003
70% Isopropyl AlcoholISOPROPYL ALCOHOLChain Drug Marketing Associationc07b7f1b-eda2-4f0f-a35d-f34ac85abab32026-05-14Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLHARRIS TEETERb3fa1454-25cd-4801-bbec-5da43a70ec7f2026-05-14WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLHARRIS TEETERc4e816c7-a8a2-404c-9354-eaaed6dbf0f52026-05-14WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Midnight MuskALCOHOLShenzhen Lantern Scicence Co.,Ltd.51ae8f8d-8969-9605-e063-6394a90a42252026-05-13WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Meadow MirageALCOHOLShenzhen Lantern Scicence Co.,Ltd.51af80be-dcc8-f5c3-e063-6394a90a32542026-05-13WarningsExact 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