Home NDC 50865-213 Foaming Advanced Antibacterial Hand
Product NDC 50865-213
11-digit product format 508650213
Labeler code 50865
Product ID 50865-213_298e23fa-a68d-383f-e063-6294a90a2e34
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 · 12 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 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Additional Listing Data#
Finished product Yes
Brand name base Foaming Advanced Antibacterial 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 50865-213-13 Foaming Advanced Antibacterial Hand 3785 mL in 1 BOTTLE, PLASTIC SOAP 3785 9 50865-213-17 Foaming Advanced Antibacterial Hand 50 mL in 1 BOTTLE, PLASTIC SOAP 50 9 50865-213-24 Foaming Advanced Antibacterial Hand 1000 mL in 1 BOTTLE, PLASTIC SOAP 1000 9 50865-213-41 Foaming Advanced Antibacterial Hand 1000 mL in 1 BAG SOAP 1000 9 50865-213-50 Foaming Advanced Antibacterial Hand 1200 mL in 1 BAG SOAP 1200 9 50865-213-52 Foaming Advanced Antibacterial Hand 1000 mL in 1 BOTTLE, PLASTIC SOAP 1000 9 50865-213-78 Foaming Advanced Antibacterial Hand 950 mL in 1 BOTTLE, PLASTIC SOAP 950 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50865-213 FOAMING ADVANCED ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) SOAP [KUTOL PRODUCTS COMPANY] 9 Current NDC, Legacy NDC, 7 package rows 20241220_7abc56b5-4446-4464-9b94-6c55f8bb9b74.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 50865-213-09 50865021309 3875 mL in 1 BOTTLE (50865-213-09) 3875 ml 2019-01-01 0000-00-00 No No Current 50865-213-10 50865021310 1000 mL in 1 BAG (50865-213-10) 1000 ml 2019-01-01 0000-00-00 No No Current 50865-213-13 50865021313 3785 mL in 1 BOTTLE, PLASTIC (50865-213-13) 3785 ml 2015-10-01 0000-00-00 No No Current 50865-213-14 50865021314 950 mL in 1 BOTTLE (50865-213-14) 950 ml 2019-01-01 0000-00-00 No No Current 50865-213-17 50865021317 50 mL in 1 BOTTLE, PLASTIC (50865-213-17) 50 ml 2015-10-01 0000-00-00 No No Current 50865-213-24 50865021324 1000 mL in 1 BOTTLE, PLASTIC 1000 ml Historical 50865-213-41 50865021341 1000 mL in 1 BAG (50865-213-41) 1000 ml 2015-10-01 0000-00-00 No No Current 50865-213-44 50865021344 1000 mL in 1 BAG (50865-213-44) 1000 ml 2015-10-01 0000-00-00 No No Current 50865-213-50 50865021350 1200 mL in 1 BAG (50865-213-50) 1200 ml 2015-10-01 0000-00-00 No No Current 50865-213-52 50865021352 1000 mL in 1 BOTTLE, PLASTIC (50865-213-52) 1000 ml 2015-10-01 0000-00-00 No No Current 50865-213-78 50865021378 950 mL in 1 BOTTLE, PLASTIC (50865-213-78) 950 ml 2015-10-01 0000-00-00 No No Current