Home NDC 50865-215-12 Antibacterial Hand Cleanser
Product NDC 50865-215
Requested package NDC 50865-215-12
11-digit product format 508650215
Labeler code 50865
Product ID 50865-215_03fbe342-a3b7-9a63-e063-6294a90a15f2
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 2017-08-17
Substance BENZALKONIUM CHLORIDE
Active strength .013 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 · 10 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 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…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…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 Antibacterial Hand Cleanser
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE .013 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 50865-215-09 Antibacterial Hand Cleanser 3785 mL in 1 BOTTLE, PLASTIC SOAP 3785 4 50865-215-12 Antibacterial Hand Cleanser 1200 mL in 1 BAG SOAP 1200 4 50865-215-19 Antibacterial Hand Cleanser 237 mL in 1 BOTTLE, PUMP SOAP 237 4 50865-215-65 Antibacterial Hand Cleanser 800 mL in 1 BAG SOAP 800 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50865-215 ANTIBACTERIAL HAND CLEANSER (BENZALKONIUM CHLORIDE) SOAP [KUTOL PRODUCTS COMPANY] 4 Current NDC, Legacy NDC, 4 package rows 20241220_56f50eda-5399-1bfe-e054-00144ff8d46c.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 50865-215-12 50865021512 1200 mL in 1 BAG (50865-215-12) 1200 ml 2017-08-17 No No Current