Home NDC 0395-1003 Humco Gentian Violet 1%
Product NDC 0395-1003
11-digit product format 003951003
Labeler code 0395
Product ID 0395-1003_5634a424-3290-eefc-e063-6294a90a2290
Type HUMAN OTC DRUG
Nonproprietary name Gentian Violet 1%
Dosage form LIQUID
Route TOPICAL
Labeler Humco Holding Group, Inc.
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2008-01-01
Marketing end 2029-02-01
Substance GENTIAN VIOLET
Active strength 10 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 1% Active Ingredients# Ingredient, Strength table Ingredient Strength GENTIAN VIOLET 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination J4Z741D6O5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310481 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0395-1003-92 Humco Gentian Violet 1% 59 mL in 1 BOTTLE, PLASTIC LIQUID 59 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0395-1003 HUMCO GENTIAN VIOLET 1% (GENTIAN VIOLET 1%) LIQUID [HUMCO HOLDING GROUP, INC.] 5 Current NDC, Legacy NDC, 1 package rows 20231216_7b4e6572-cb44-491d-8063-f7519307a8e5.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 88 of 114 · 2,277 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0395-1003-92 00395100392 59 mL in 1 BOTTLE, PLASTIC (0395-1003-92) 59 ml 2017-11-13 2029-02-01 No No Current