KLENLII HAND SANII ALCOHOL SANITIZER

Product NDC
78016-107
Requested package NDC
78016-107-16
11-digit product format
780160107
Labeler code
78016
Product ID
78016-107_d5d288db-d5b8-615b-e053-2995a90ad731
Type
HUMAN OTC DRUG
Nonproprietary name
ETHYL ALCOHOL, ISOPROPYL ALCOHOL
Dosage form
SPRAY
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; ISOPROPYL ALCOHOL
Active strength
63 mL/100mL; mL/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage78016-10778016-107-16IInactivated by FDA2026-10-05

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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage78016-10778016-107-16IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
78016-107-112026-01-29KLENLII HAND SANII ALCOHOL SANITIZER SPRAY (63% ETHYL ALCOHOL, 7% IPA) (78016-107)
78016-107-122026-01-29KLENLII HAND SANII ALCOHOL SANITIZER SPRAY (63% ETHYL ALCOHOL, 7% IPA) (78016-107)
78016-107-142026-01-29KLENLII HAND SANII ALCOHOL SANITIZER SPRAY (63% ETHYL ALCOHOL, 7% IPA) (78016-107)
78016-107-162026-01-29KLENLII HAND SANII ALCOHOL SANITIZER SPRAY (63% ETHYL ALCOHOL, 7% IPA) (78016-107)
78016-107-182026-01-29KLENLII HAND SANII ALCOHOL SANITIZER SPRAY (63% ETHYL ALCOHOL, 7% IPA) (78016-107)
78016-107-112024-05-11KLENLII HAND SANII ALCOHOL SANITIZER SPRAY (63% ETHYL ALCOHOL, 7% IPA) (78016-107)
78016-107-122024-05-11KLENLII HAND SANII ALCOHOL SANITIZER SPRAY (63% ETHYL ALCOHOL, 7% IPA) (78016-107)
78016-107-142024-05-11KLENLII HAND SANII ALCOHOL SANITIZER SPRAY (63% ETHYL ALCOHOL, 7% IPA) (78016-107)
78016-107-162024-05-11KLENLII HAND SANII ALCOHOL SANITIZER SPRAY (63% ETHYL ALCOHOL, 7% IPA) (78016-107)
78016-107-182024-05-11KLENLII HAND SANII ALCOHOL SANITIZER SPRAY (63% ETHYL ALCOHOL, 7% IPA) (78016-107)
78016-107-112024-01-30KLENLII HAND SANII ALCOHOL SANITIZER SPRAY (63% ETHYL ALCOHOL, 7% IPA) (78016-107)
78016-107-122024-01-30KLENLII HAND SANII ALCOHOL SANITIZER SPRAY (63% ETHYL ALCOHOL, 7% IPA) (78016-107)
78016-107-142024-01-30KLENLII HAND SANII ALCOHOL SANITIZER SPRAY (63% ETHYL ALCOHOL, 7% IPA) (78016-107)
78016-107-162024-01-30KLENLII HAND SANII ALCOHOL SANITIZER SPRAY (63% ETHYL ALCOHOL, 7% IPA) (78016-107)
78016-107-182024-01-30KLENLII HAND SANII ALCOHOL SANITIZER SPRAY (63% ETHYL ALCOHOL, 7% IPA) (78016-107)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78016-107-11KLENLII HAND SANII ALCOHOL SANITIZER3785 mL in 1 JUGSPRAY37854
78016-107-12KLENLII HAND SANII ALCOHOL SANITIZER59 mL in 1 BOTTLESPRAY594
78016-107-14KLENLII HAND SANII ALCOHOL SANITIZER118 mL in 1 BOTTLESPRAY1184
78016-107-16KLENLII HAND SANII ALCOHOL SANITIZER476 mL in 1 BOTTLESPRAY4764
78016-107-18KLENLII HAND SANII ALCOHOL SANITIZER238 mL in 1 BOTTLESPRAY2384

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78016-107KLENLII HAND SANII ALCOHOL SANITIZER (ETHYL ALCOHOL, ISOPROPYL ALCOHOL) SPRAY [KLENLII COMPANY]4Legacy NDC, 5 package rows20240513_2be72fb4-1295-44dd-bf02-97a42b1db403.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2397769ethanol 63 % / isopropyl alcohol 7 % Topical SprayPSN2be72fb4-1295-44dd-bf02-97a42b1db4034
2397769ethanol 0.63 ML/ML / isopropyl alcohol 0.07 ML/ML Topical SpraySCD2be72fb4-1295-44dd-bf02-97a42b1db4034
2397769ethanol 63 % / isopropyl alcohol 7 % Topical SpraySY2be72fb4-1295-44dd-bf02-97a42b1db4034

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78016-107-1678016010716476 mL in 1 BOTTLE (78016-107-16) 476 ml2020-05-270000-00-00NoNoCurrent