FDA.reportPublic FDA data

Humco Gentian Violet 2%

Product NDC
0395-1005
11-digit product format
003951005
Labeler code
0395
Product ID
0395-1005_5634c662-c67b-1824-e063-6294a90ac331
Type
HUMAN OTC DRUG
Nonproprietary name
Gentian Violet 2%
Dosage form
LIQUID
Route
TOPICAL
Labeler
Humco Holding Group, Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-01-01
Marketing end
2027-07-01
Substance
GENTIAN VIOLET
Active strength
20 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
Humco Gentian Violet 2%

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GENTIAN VIOLET20 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
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
a07f61e5-0215-419a-a68a-1d814417c35fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0395-1005-92Humco Gentian Violet 2%59 mL in 1 BOTTLE, PLASTICLIQUID599

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0395-1005-92ML - Milliliter0395-1005ccca0681-0c63-4c85-8642-4c990acc617012013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GENTIAN VIOLETACTIVE INGREDIENTJ4Z741D6O5HUMCO GENTIAN VIOLET 2% (GENTIAN VIOLET 2%) LIQUID [HUMCO HOLDING GROUP, INC.]1
GENTIAN VIOLET CATIONACTIVE MOIETY3GVJ31T6YYHUMCO GENTIAN VIOLET 2% (GENTIAN VIOLET 2%) LIQUID [HUMCO HOLDING GROUP, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MHUMCO GENTIAN VIOLET 2% (GENTIAN VIOLET 2%) LIQUID [HUMCO HOLDING GROUP, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RHUMCO GENTIAN VIOLET 2% (GENTIAN VIOLET 2%) LIQUID [HUMCO HOLDING GROUP, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0395-1005HUMCO GENTIAN VIOLET 2% (GENTIAN VIOLET 2%) LIQUID [HUMCO HOLDING GROUP, INC.]9Current NDC, Legacy NDC, 1 package rows20231216_a07f61e5-0215-419a-a68a-1d814417c35f.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 74 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Universal 70% Rubbing Alcohol with Wintergreen and GlycerinUNIVERSAL 70% RUBBING ALCOHOL WITH WINTERGREEN AND GLYCERIN - ISOPROPYL ALCOHOL LIQUIDTSM BRANDS LLC390c6afd-e2c2-414c-e063-6294a90ae1192025-07-03WarningsExact identifier
application number: M003
RUBBING ALCOHOL 50 PERCENT WINTERGREENISOPROPYL ALCOHOLViny Health and Beauty Products Inc4b83f562-7ec7-72f3-e063-6294a90aba4d2025-07-01WarningsExact identifier
application number: M003
RUBBING ALCOHOL 50 PERCENTISOPROPYL ALCOHOLViny Health and Beauty Products Inc4b83e678-b79f-6dd6-e063-6294a90ad09d2025-07-01WarningsExact identifier
application number: M003
RUBBING ALCOHOL 70 PERCENTISOPROPYL ALCOHOLViny Health and Beauty Products Inc4babe369-3a35-34b5-e063-6394a90a68322025-07-01WarningsExact identifier
application number: M003
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd38c323e2-9a9a-f898-e063-6394a90aa2262025-06-30WarningsExact identifier
application number: M003
UNIVERSAL ISOPROPYL RUBBING ALCOHOL 70% - isopropyl alcohol liquidUNIVERSAL ISOPROPYL RUBBING ALCOHOL 70% - ISOPROPYL ALCOHOL LIQUIDTSM BRANDS LLC38d03665-6e76-c76f-e063-6294a90a9e332025-06-30WarningsExact identifier
application number: M003
HAND SANITIZER FRESH LINENALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd322e492b-0690-a345-e063-6294a90aef2c2025-06-29WarningsExact identifier
application number: M003
HAND SANITIZER VANILLAALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd322e98dd-22ec-d4a3-e063-6394a90a80fa2025-06-29WarningsExact identifier
application number: M003
HAND SANITIZER STRAWBERRY FIZZALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd322e3045-14dc-ac2e-e063-6394a90a9b8a2025-06-29WarningsExact identifier
application number: M003
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd38b857ee-760c-e98b-e063-6294a90a7c592025-06-29WarningsExact identifier
application number: M003
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd38b857ee-760e-e98b-e063-6294a90a7c592025-06-29WarningsExact identifier
application number: M003
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd38b87b19-7663-d5c5-e063-6294a90a9e872025-06-29WarningsExact identifier
application number: M003
Smart Care Assorted Hand Sanitizer -Passion FruitALCOHOLShenzhen Lantern Scicence Co.,Ltd.38895b60-f5a8-880f-e063-6394a90aa7062025-06-27WarningsExact identifier
application number: M003
Smart Care Assorted Hand Sanitizer -HibiscusALCOHOLShenzhen Lantern Scicence Co.,Ltd.3889d467-b179-bac4-e063-6394a90a61562025-06-27WarningsExact identifier
application number: M003
Smart Care Assorted Hand Sanitize -Cucumber MelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.388a975c-b0b6-b80e-e063-6294a90a18142025-06-27WarningsExact identifier
application number: M003
Smart Care Assorted Hand Sanitizer -Sweet CitrusALCOHOLShenzhen Lantern Scicence Co.,Ltd.388abca3-12fb-449a-e063-6394a90aea982025-06-27WarningsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINERugby Laboratoriesb2bcb69e-8ffb-23ee-e053-2995a90aee212025-06-27WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer - Caramel HoneyALCOHOLShenzhen Lantern Scicence Co.,Ltd.3874c203-2c8b-79b3-e063-6294a90aedfb2025-06-26WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer - Sweet CitrusALCOHOLShenzhen Lantern Scicence Co.,Ltd.38863865-9361-fd1a-e063-6394a90a84f42025-06-26WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer - Squishmallows PattyALCOHOLShenzhen Lantern Scicence Co.,Ltd.38613f78-8480-637d-e063-6394a90a4ef32025-06-25WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313997gentian violet 2 % Topical SolutionPSNa07f61e5-0215-419a-a68a-1d814417c35f9
313997gentian violet 20 MG/ML Topical SolutionSCDa07f61e5-0215-419a-a68a-1d814417c35f9
313997gentian violet 2 % Topical SolutionSYa07f61e5-0215-419a-a68a-1d814417c35f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0395-1005-920039510059259 mL in 1 BOTTLE, PLASTIC (0395-1005-92) 59 ml2017-11-132027-07-01NoNoCurrent