Home NDC 78016-102-12 KLENLII HAND SANII ALCOHOL SANITIZER
Product NDC 78016-102
Requested package NDC 78016-102-12
11-digit product format 780160102
Labeler code 78016
Product ID 78016-102_d5d22f58-3c0b-2dec-e053-2a95a90abc04
Type HUMAN OTC DRUG
Nonproprietary name ETHYL ALCOHOL
Dosage form GEL
Route TOPICAL
Labeler Klenlii Company
Application part333A
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2020-05-27
Marketing end 0000-00-00
Substance ALCOHOL
Active strength 63 mL/100mL
NDC exclude flag No
Listing certified through 2023-12-31
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 · 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 2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 78016-102 78016-102-12 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 78016-102-11 KLENLII HAND SANII ALCOHOL SANITIZER 3785 mL in 1 JUG GEL 3785 5 78016-102-12 KLENLII HAND SANII ALCOHOL SANITIZER 59 mL in 1 BOTTLE GEL 59 5 78016-102-14 KLENLII HAND SANII ALCOHOL SANITIZER 118 mL in 1 BOTTLE GEL 118 5 78016-102-16 KLENLII HAND SANII ALCOHOL SANITIZER 476 mL in 1 BOTTLE GEL 476 5 78016-102-18 KLENLII HAND SANII ALCOHOL SANITIZER 237 mL in 1 BOTTLE GEL 237 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78016-102 KLENLII HAND SANII ALCOHOL SANITIZER (ETHYL ALCOHOL) GEL [KLENLII COMPANY] 5 Legacy NDC, 5 package rows 20240511_8af5941e-68ac-4b3e-a25d-530904c204de.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 78016-102-12 78016010212 59 mL in 1 BOTTLE (78016-102-12) 59 ml 2020-05-27 0000-00-00 No No Current