Home NDC 50865-017-09 E2 SANITIZING HAND
Product NDC 50865-017
Requested package NDC 50865-017-09
11-digit product format 508650017
Labeler code 50865
Product ID 50865-017_298f1da8-676b-6cb9-e063-6294a90a78ab
Type HUMAN OTC DRUG
Nonproprietary name E2 SANITIZING HAND
Dosage form SOAP
Route TOPICAL
Labeler KUTOL PRODUCTS COMPANY
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-09-15
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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 50865-017 50865-017-09 I Inactivated by FDA excluded / ndc_excluded.zip 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 E2 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 50865-017-03 E2 SANITIZING HAND 209000 mL in 1 DRUM SOAP 209000 9 50865-017-07 E2 SANITIZING HAND 4000 mL in 1 BOTTLE, PLASTIC SOAP 4000 9 50865-017-09 E2 SANITIZING HAND 4000 mL in 1 BOTTLE, PLASTIC SOAP 4000 9 50865-017-41 E2 SANITIZING HAND 1000 mL in 1 BAG SOAP 1000 9 50865-017-65 E2 SANITIZING HAND 800 mL in 1 BAG SOAP 800 9 50865-017-67 E2 SANITIZING HAND 2000 mL in 1 BOTTLE, PLASTIC SOAP 2000 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50865-017 E2 SANITIZING HAND SOAP [KUTOL PRODUCTS COMPANY] 9 Current NDC, Legacy NDC, 6 package rows 20241220_70357eaf-8cd8-4c5e-b7a8-ae2fbba0ca2e.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 50865-017-09 50865001709 4000 mL in 1 BOTTLE, PLASTIC (50865-017-09) 4000 ml 2015-09-15 0000-00-00 No No Current