Home NDC 54057-083 AFFEX Foaming Antimicrobial Hand So ap
Product NDC 54057-083
11-digit product format 540570083
Labeler code 54057
Product ID 54057-083_297b2a97-abd1-a1c4-e063-6394a90ab946
Type HUMAN OTC DRUG
Nonproprietary name Chloroxylenol
Dosage form LIQUID
Route TOPICAL
Labeler Afflink, Inc.
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-11-15
Substance CHLOROXYLENOL
Active strength .003 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 Foaming Antimicrobial Hand So ap
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLOROXYLENOL .003 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0F32U78V2Q 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 54057-083-42 AFFEX Foaming Antimicrobial Hand So ap 1250 mL in 1 PACKAGE LIQUID 1250 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54057-083 AFFEX FOAMING ANTIMICROBIAL HAND SO AP (CHLOROXYLENOL) LIQUID [AFFLINK, INC.] 4 Current NDC, Legacy NDC, 1 package rows 20241220_d97c8bb5-78a7-44e0-b68d-890b00f171d8.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 54057-083-42 54057008342 1250 mL in 1 PACKAGE (54057-083-42) 1250 ml 2013-11-15 2023-12-31 No No Current