Home NDC 50865-683 Foaming Sanitizing Hand
Product NDC 50865-683
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 · 56 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50865-683-09 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50865-683-03 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50865-683-78 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50865-683-09 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50865-683-03 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50865-683-78 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50865-683-09 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50865-683-03 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50865-683-78 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50865-683-09 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50865-683-03 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50865-683-78 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50865-683-09 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50865-683-03 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50865-683-78 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50865-683-09 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50865-683-03 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50865-683-78 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50865-683-09 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50865-683-03 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50865-683-78 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50865-683-09 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50865-683-03 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50865-683-78 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50865-683-09 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50865-683-03 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50865-683-78 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50865-683-03 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50865-683-09 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50865-683-78 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50865-683-03 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50865-683-09 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50865-683-78 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50865-683-03 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50865-683-09 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50865-683-78 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 50865-683-44 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 50865-683-41 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 50865-683-04 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 50865-683-17 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 50865-683-44 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 50865-683-41 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 50865-683-04 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 50865-683-17 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 50865-683-44 I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 50865-683-41 I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 50865-683-04 I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 50865-683-17 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 50865-683-44 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 50865-683-41 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 50865-683-04 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 50865-683-17 I Inactivated by FDA 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 50865-683-03 50865068303 4000 mL in 1 DRUM 4000 ml Historical 50865-683-04 50865068304 1000 mL in 1 BAG (50865-683-04) 1000 ml 2017-06-12 No No Current 50865-683-09 50865068309 1000 mL in 1 BOTTLE, PLASTIC 1000 ml Historical 50865-683-17 50865068317 50 mL in 1 BOTTLE, PLASTIC (50865-683-17) 50 ml 2016-06-12 No No Current 50865-683-41 50865068341 1000 mL in 1 BAG (50865-683-41) 1000 ml 2015-10-01 No No Current 50865-683-44 50865068344 1000 mL in 1 BAG (50865-683-44) 1000 ml 2016-06-12 No No Current 50865-683-78 50865068378 950 mL in 1 BOTTLE, PLASTIC 950 ml Historical