Home NDC 50865-683-44 Foaming Sanitizing Hand
Product NDC 50865-683
Requested package NDC 50865-683-44
11-digit product format 508650683
Labeler code 50865
Product ID 50865-683_298dd564-db49-47a0-e063-6394a90ac4c3
Type HUMAN OTC DRUG
Nonproprietary name benzalkonium chloride
Dosage form SOAP
Route TOPICAL
Labeler Kutol Products Company
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-10-01
Substance BENZALKONIUM CHLORIDE
Active strength .003 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 8dfbde2a14a4…c9ff85d89658…
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 Foaming Sanitizing Hand
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE .003 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.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50865-683-03 Foaming Sanitizing Hand 4000 mL in 1 DRUM SOAP 4000 6 50865-683-04 Foaming Sanitizing Hand 1000 mL in 1 BAG SOAP 1000 6 50865-683-09 Foaming Sanitizing Hand 1000 mL in 1 BOTTLE, PLASTIC SOAP 1000 6 50865-683-17 Foaming Sanitizing Hand 50 mL in 1 BOTTLE, PLASTIC SOAP 50 6 50865-683-41 Foaming Sanitizing Hand 1000 mL in 1 BAG SOAP 1000 6 50865-683-44 Foaming Sanitizing Hand 1000 mL in 1 BAG SOAP 1000 6 50865-683-78 Foaming Sanitizing Hand 950 mL in 1 BOTTLE, PLASTIC SOAP 950 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50865-683 FOAMING SANITIZING HAND (BENZALKONIUM CHLORIDE) SOAP [KUTOL PRODUCTS COMPANY] 6 Current NDC, Legacy NDC, 7 package rows 20241220_95f0af0e-7889-4c2a-9573-4242acfd6684.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 50865-683-44 50865068344 1000 mL in 1 BAG (50865-683-44) 1000 ml 2016-06-12 No No Current