Home NDC 54057-400 AFFEX Antibacterial Plum Foam Handwash
Product NDC 54057-400
11-digit product format 540570400
Labeler code 54057
Product ID 54057-400_29a07adc-ca74-9509-e063-6294a90a4d6e
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium Chloride
Dosage form LIQUID
Route TOPICAL
Labeler Afflink, Inc.
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-04-30
Substance BENZALKONIUM CHLORIDE
Active strength .005 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 AFFEX Antibacterial Plum Foam Handwash
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE .005 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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54057-400-40 AFFEX Antibacterial Plum Foam Handwash 1200 mL in 1 PACKAGE LIQUID 1200 3 54057-400-42 AFFEX Antibacterial Plum Foam Handwash 1250 mL in 1 PACKAGE LIQUID 1250 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54057-400 AFFEX ANTIBACTERIAL PLUM FOAM HANDWASH (BENZALKONIUM CHLORIDE) LIQUID [AFFLINK, INC.] 3 Current NDC, Legacy NDC, 2 package rows 20241222_3f51700a-0e8f-4091-ab0d-6751364304a4.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 Marketing end Sample Exclude flag Status 54057-400-40 54057040040 1200 mL in 1 PACKAGE (54057-400-40) 1200 ml 2017-04-30 0000-00-00 No No Current 54057-400-42 54057040042 1250 mL in 1 PACKAGE (54057-400-42) 1250 ml 2017-04-30 0000-00-00 No No Current