FDA.reportPublic FDA data

Gentian Violet 2%

Product NDC
54633-014
11-digit product format
546330014
Labeler code
54633
Product ID
54633-014_47e3681f-3a81-c942-e063-6294a90a530c
Type
HUMAN OTC DRUG
Nonproprietary name
gentian violet 2%
Dosage form
SOLUTION
Route
TOPICAL
Labeler
The Podiatree Company
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-10-14
Substance
GENTIAN VIOLET
Active strength
2 g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
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 2%
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GENTIAN VIOLET2 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
313997Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
60ba9bb0-cc7a-1ccf-e053-2a91aa0ac4b8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54633-014-02Gentian Violet 2%59.14 mL in 1 BOTTLE, PLASTICSOLUTION59.143

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54633-014-02ML - Milliliter54633-0144884732a-fc88-4e16-af9f-31eb44bf42db12014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GENTIAN VIOLETACTIVE INGREDIENTJ4Z741D6O5GENTIAN VIOLET 2% SOLUTION [THE PODIATREE COMPANY]1
GENTIAN VIOLET CATIONACTIVE MOIETY3GVJ31T6YYGENTIAN VIOLET 2% SOLUTION [THE PODIATREE COMPANY]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MGENTIAN VIOLET 2% SOLUTION [THE PODIATREE COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RGENTIAN VIOLET 2% SOLUTION [THE PODIATREE COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54633-014GENTIAN VIOLET 2% SOLUTION [THE PODIATREE COMPANY]2Current NDC, Legacy NDC, 1 package rows20171220_60ba9bb0-cc7a-1ccf-e053-2a91aa0ac4b8.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 41 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Benzalkonium ChlorideSANITIZING HAND WIPESALO NEW YORK LLCd3afde78-b9f6-3648-e053-2a95a90a40242026-01-15WarningsExact identifier
application number: M003
BIOPURE Hand Sanitizer Spray-Coastal GlowHAND SANITIZER SPRAYQuest USA Corp48254577-9f1e-9389-e063-6394a90a92f12026-01-15WarningsExact identifier
application number: M003
hi peach layneETHYL ALCOHOLZhejiang Jinghui Cosmetics Share Co., Ltd.487a4c8e-4fb3-6bff-e063-6294a90abd532026-01-15WarningsExact identifier
application number: M003
Gold Bond Hydrating Hand SanitizerETHYL ALCOHOLChattem, Inc.96fe0191-0d34-4bf3-8f93-0e64764c353a2026-01-14WarningsExact identifier
application number: M003
Alcohol Prep AwabsISOPROPYL ALCOHOLEnlightening Pallet Industry Co., Limited26c7db1e-86a9-8765-e063-6294a90a634f2026-01-14WarningsExact identifier
application number: M003
Caring HandsHAND MOISTURIZING SANITIZERGleeco Labs LLC2ced5dc5-47dd-1b71-e063-6394a90a0e3d2026-01-14WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLDealMed Medical Supplies LLC04e6edb5-07ef-4ed4-ba68-ed183386b5ab2026-01-13WarningsExact identifier
application number: M003
Dermoplast First AidBENZETHONIUM CHLORIDE AND BENZOCAINEAdvantice Health, LLCec93011d-7069-4021-8dd2-3d51eb6026e12026-01-13WarningsExact identifier
application number: M003
WISH ISOPROPYL ALCOHOLWISH ISOPROPYL ALCOHOLClick Products LLC484befce-ecfe-5514-e063-6294a90a169c2026-01-13WarningsExact identifier
application number: M003
WISH RUBBING ALCOHOL 32ozWISH RUBBING ALCOHOL 32OZ 70%CLICK PRODUCTS LLC4836b564-0b8c-2fb4-e063-6394a90a9c4a2026-01-13WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEDealMed Medical Supplies LLC6d1ddf10-8873-4781-9165-bb1c4bbccfc92026-01-13WarningsExact identifier
application number: M003
AVANCE INCONTINENCE CAREBENZETHONIUM CHLORIDESMART CHOICE MEDICAL INC.e2c51699-d4da-5b88-e053-2995a90afd7f2026-01-12WarningsExact identifier
application number: M003
AVANCE INCONTINENCE CAREBENZETHONIUM CHLORIDESMART CHOICE MEDICAL INC.e297b705-8070-f7c3-e053-2a95a90a8c5b2026-01-12WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEHydrox Laboratories6e5709b4-cc56-4768-b704-1d9b0e3efec72026-01-12WarningsExact identifier
application number: M003
Isopropyl Alcohol 50%ISOPROPYL ALCOHOL 50%Hydrox Laboratories930bb3a3-5ca3-414c-b4fb-c71ee17fc7462026-01-12WarningsExact identifier
application number: M003
Povidone IodinePOVIDONE-IODINESion Biotext Medical Ltd04438f9e-302c-431b-b3ad-d2c50ca01ad82026-01-12WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLHydrox Laboratoriesf2f07464-6bd5-434c-8dea-0ba659c0e5492026-01-12WarningsExact identifier
application number: M003
Isopropyl Alcohol with Wintergreen 70%ISOPROPYL ALCOHOL WITH WINTERGREEN 70%Hydrox Laboratories5845f723-8866-4738-bec6-621041899f572026-01-12WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLHydrox Laboratories2042cf29-52c5-4f1e-aae6-78e025994d182026-01-12WarningsExact identifier
application number: M003
Isopropyl Alcohol with Wintergreen 50%ISOPROPYL ALCOHOL WITH WINTERGREEN 50%Hydrox Laboratories3a15a900-2b48-487f-b252-a1a1e0d0abfc2026-01-12WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313997gentian violet 2 % Topical SolutionPSN60ba9bb0-cc7a-1ccf-e053-2a91aa0ac4b83
313997gentian violet 20 MG/ML Topical SolutionSCD60ba9bb0-cc7a-1ccf-e053-2a91aa0ac4b83
313997gentian violet 2 % Topical SolutionSY60ba9bb0-cc7a-1ccf-e053-2a91aa0ac4b83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54633-014-025463300140259.14 mL in 1 BOTTLE, PLASTIC (54633-014-02) 59.14 ml2014-10-140000-00-00NoNoCurrent