Home NDC 78016-104 KLENLII HAND
Product NDC 78016-104
11-digit product format 780160104
Labeler code 78016
Product ID 78016-104_f6aa3bb9-6ebb-4376-bdab-b9d7844d1c3a
Type HUMAN OTC DRUG
Nonproprietary name CHLOROXYLENOL
Dosage form SOAP
Route TOPICAL
Labeler Klenlii Company
Application part333A
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2020-06-14
Marketing end 0000-00-00
Substance ALCOHOL
Active strength 63 mL/100mL
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 78016-104-18 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 78016-104-18 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 78016-104-18 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 78016-104-18 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 78016-104-18 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 78016-104-18 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 78016-104-18 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 78016-104-18 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 78016-104-18 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 78016-104-18 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 78016-104-18 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 78016-104-18 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 78016-104-11 KLENLII HANDANTIBACTERIAL 3785 mL in 1 JUG SOAP 3785 1 78016-104-12 KLENLII HANDANTIBACTERIAL 59 mL in 1 BOTTLE SOAP 59 1 78016-104-14 KLENLII HANDANTIBACTERIAL 118 mL in 1 BOTTLE SOAP 118 1 78016-104-16 KLENLII HANDANTIBACTERIAL 476 mL in 1 BOTTLE SOAP 476 1 78016-104-18 KLENLII HANDANTIBACTERIAL 238 mL in 1 BOTTLE SOAP 238 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78016-104 KLENLII HAND ANTIBACTERIAL (CHLOROXYLENOL) SOAP [KLENLII COMPANY] 1 Legacy NDC, 5 package rows 20200615_6781ed8d-21b0-49dc-8323-467b9b11e074.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 78016-104-11 78016010411 3785 mL in 1 JUG 3785 ml Historical 78016-104-12 78016010412 59 mL in 1 BOTTLE 59 ml Historical 78016-104-14 78016010414 118 mL in 1 BOTTLE 118 ml Historical 78016-104-16 78016010416 476 mL in 1 BOTTLE 476 ml Historical 78016-104-18 78016010418 238 mL in 1 BOTTLE 238 ml Historical