Home NDC 80976-100-01 WIPES4HEALTH
Product NDC 80976-100
Requested package NDC 80976-100-01
11-digit product format 809760100
Labeler code 80976
Product ID 80976-100_e879b8f2-5e01-46a2-8550-922214687d59
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium Chloride
Dosage form CLOTH
Route TOPICAL
Labeler Bubble Marketing LLC
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-11-04
Substance BENZALKONIUM CHLORIDE
Active strength .13 g/100mL
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 WIPES4HEALTH
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE .13 g/100mL
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 1038558 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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80976-100 WIPES4HEALTH (BENZALKONIUM CHLORIDE) CLOTH [BUBBLE MARKETING LLC] 10 Current NDC, Legacy NDC, 10 package rows 20241220_5d6dd15b-d087-4f25-bd2b-035ecacd5f97.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 110 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 Marketing end Sample Exclude flag Status 80976-100-01 80976010001 1000 PACKAGE in 1 BAG (80976-100-01) / 3.15 mL in 1 PACKAGE 1000 package 2020-11-04 0000-00-00 No No Current