Home NDC 85131-013 Durashield
Product NDC 85131-013
11-digit product format 851310013
Labeler code 85131
Product ID 85131-013_b9f737e2-25dc-44cc-aa07-a5a77758473c
Type HUMAN OTC DRUG
Nonproprietary name benzalkonium chloride
Dosage form LOTION
Route TOPICAL
Labeler Advanced Biomedical Incorporated
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-12-18
Substance BENZALKONIUM CHLORIDE
Active strength .13 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
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 Durashield
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE .13 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 SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85131-013-00 Durashield 0.33 mL in 1 BOTTLE LOTION 0.33 1 85131-013-02 Durashield 60 mL in 1 BOTTLE LOTION 60 1 85131-013-04 Durashield 118 mL in 1 BOTTLE LOTION 118 1 85131-013-08 Durashield 237 mL in 1 BOTTLE, PUMP LOTION 237 1 85131-013-12 Durashield 355 mL in 1 BOTTLE, PUMP LOTION 355 1 85131-013-16 Durashield 473 mL in 1 BOTTLE, PUMP LOTION 473 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85131-013 DURASHIELD (BENZALKONIUM CHLORIDE) LOTION [ADVANCED BIOMEDICAL INCORPORATED] 1 Current NDC, 6 package rows 20250116_b0723781-225a-46c6-907c-5c5c48f383b8.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 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85131-013-00 85131001300 .33 mL in 1 BOTTLE (85131-013-00) 2024-12-18 No No Current 85131-013-02 85131001302 60 mL in 1 BOTTLE (85131-013-02) 60 ml 2024-12-18 No No Current 85131-013-04 85131001304 118 mL in 1 BOTTLE (85131-013-04) 118 ml 2024-12-18 No No Current 85131-013-08 85131001308 237 mL in 1 BOTTLE, PUMP (85131-013-08) 237 ml 2024-12-18 No No Current 85131-013-12 85131001312 355 mL in 1 BOTTLE, PUMP (85131-013-12) 355 ml 2024-12-18 No No Current 85131-013-16 85131001316 473 mL in 1 BOTTLE, PUMP (85131-013-16) 473 ml 2024-12-18 No No Current