Home NDC 82645-917 Gentian Violet 1%
Product NDC 82645-917
11-digit product format 826450917
Labeler code 82645
Product ID 82645-917_5634adec-3709-bcdf-e063-6394a90ae5a2
Type HUMAN OTC DRUG
Nonproprietary name Gentian Violet 1%
Dosage form LIQUID
Route TOPICAL
Labeler Pharma Nobis, LLC
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 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 82645-917-91 Gentian Violet 1% 30 mL in 1 BOTTLE, PLASTIC LIQUID 30 2 82645-917-92 Gentian Violet 1% 59 mL in 1 BOTTLE, PLASTIC LIQUID 59 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82645-917 GENTIAN VIOLET 1% LIQUID [PHARMA NOBIS, LLC] 2 Current NDC, Legacy NDC, 2 package rows 20231227_e42fa7d2-47ef-0e82-e053-2995a90a67c5.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 100 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 82645-917-91 82645091791 30 mL in 1 BOTTLE, PLASTIC (82645-917-91) 30 ml 2017-11-13 2028-04-01 No No Current 82645-917-92 82645091792 59 mL in 1 BOTTLE, PLASTIC (82645-917-92) 59 ml 2017-11-13 2029-02-01 No No Current