Home NDC 69469-010 Gentian Violet
Product NDC 69469-010
11-digit product format 694690010
Labeler code 69469
Product ID 69469-010_59f83eee-0ef4-754f-e063-6294a90a1547
Type HUMAN OTC DRUG
Nonproprietary name Gentian Violet
Dosage form SOLUTION
Route TOPICAL
Labeler Vitamex USA, Corp
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-09-03
Substance GENTIAN VIOLET
Active strength 10 mg/mL
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
Listing expiration 2027-12-31 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.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69469-010-01 Gentian Violet 30 mL in 1 BOTTLE, WITH APPLICATOR SOLUTION 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69469-010 GENTIAN VIOLET SOLUTION [VITAMEX USA, CORP] 1 Current NDC, 1 package rows 20240907_21742061-fc0b-f750-e063-6394a90a7508.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 44 of 115 · 2,286 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69469-010-01 69469001001 30 mL in 1 BOTTLE, WITH APPLICATOR (69469-010-01) 30 ml 2024-09-03 No No Current