Home NDC 82645-912 Merthiolate
Product NDC 82645-912
11-digit product format 826450912
Labeler code 82645
Product ID 82645-912_0d1cf782-d2a5-7dee-e063-6294a90a3604
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium Chloride
Dosage form LIQUID
Route TOPICAL
Labeler Pharma Nobis, LLC
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 1998-03-25
Substance BENZALKONIUM CHLORIDE
Active strength 1.3 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 Merthiolate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE 1.3 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F5UM2KM3W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049254 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 82645-912-92 Merthiolate 59 mL in 1 BOTTLE LIQUID 59 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82645-912 MERTHIOLATE (BENZALKONIUM CHLORIDE) LIQUID [PHARMA NOBIS, LLC] 2 Current NDC, Legacy NDC, 1 package rows 20231223_e42f727c-beaf-fe9d-e053-2995a90aafea.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 85 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 82645-912-92 82645091292 59 mL in 1 BOTTLE (82645-912-92) 59 ml 2017-11-14 0000-00-00 No No Current