Home NDC 85424-016 RoyceDerm Antibacterial Body Wash
Product NDC 85424-016
11-digit product format 854240016
Labeler code 85424
Product ID 85424-016_4a0c66b1-5a70-b9b9-e063-6294a90a3d77
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium Chloride 0.13%
Dosage form GEL
Route TOPICAL
Labeler RoyceDerm LLC
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-02-26
Substance BENZALKONIUM CHLORIDE
Active strength .65 g/500g
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 RoyceDerm Antibacterial Body Wash
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE .65 g/500g
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 1046593 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 85424-016-01 RoyceDerm Antibacterial Body Wash 500 g in 1 CARTON GEL 500 1
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 85424-016-01 85424001601 500 g in 1 CARTON (85424-016-01) 500 g 2026-02-26 No No Current