Home NDC 78691-009 BioPure Antibacterial Hand Wipes Benzalkonium Chloride 0.12% - 250 Wipes
Product NDC 78691-009
11-digit product format 786910009
Labeler code 78691
Product ID 78691-009_47485d18-f49b-df6b-e063-6294a90a46a4
Type HUMAN OTC DRUG
Nonproprietary name BENZALKONIUM CHLORIDE
Dosage form CLOTH
Route TOPICAL
Labeler QUEST USA CORP.
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-09-20
Substance BENZALKONIUM CHLORIDE
Active strength 1.2 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base BioPure Antibacterial Hand Wipes Benzalkonium Chloride 0.12% - 250 Wipes
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE 1.2 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 1038741 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 78691-009-00 BioPure Antibacterial Hand Wipes Benzalkonium Chloride 0.12% - 250 Wipes 250 in 1 CONTAINER CLOTH 250 5 78691-009-00 BioPure Antibacterial Hand Wipes Benzalkonium Chloride 0.12% - 250 Wipes 2.8 mL in 1 PATCH CLOTH 2.8 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78691-009 BIOPURE ANTIBACTERIAL HAND WIPES BENZALKONIUM CHLORIDE 0.12% - 250 WIPES (BENZALKONIUM CHLORIDE) CLOTH [QUEST USA CORP.] 4 Current NDC, Legacy NDC, 2 package rows 20241217_ae2fdb32-05c6-6d16-e053-2995a90a552d.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.
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 78691-009-00 78691000900 250 PATCH in 1 CONTAINER (78691-009-00) / 2.8 mL in 1 PATCH 250 patch 2020-09-20 0000-00-00 No No Current