FDA.reportPublic FDA data

KLENLII HAND

Product NDC
78016-106
Requested package NDC
78016-106-16
11-digit product format
780160106
Labeler code
78016
Product ID
78016-106_d5d27a80-9834-b495-e053-2995a90a23a6
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
CHLOROXYLENOL
Active strength
0 g/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 packagepackage78016-10678016-106-16IInactivated by FDA2026-10-12

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 packagepackage78016-10678016-106-16IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
78016-106-112026-01-29KLENLII HAND SOAP ANTIBACTERIAL (78016-106)
78016-106-122026-01-29KLENLII HAND SOAP ANTIBACTERIAL (78016-106)
78016-106-142026-01-29KLENLII HAND SOAP ANTIBACTERIAL (78016-106)
78016-106-162026-01-29KLENLII HAND SOAP ANTIBACTERIAL (78016-106)
78016-106-182026-01-29KLENLII HAND SOAP ANTIBACTERIAL (78016-106)
78016-106-112024-05-09KLENLII HAND SOAP ANTIBACTERIAL (78016-106)
78016-106-122024-05-09KLENLII HAND SOAP ANTIBACTERIAL (78016-106)
78016-106-142024-05-09KLENLII HAND SOAP ANTIBACTERIAL (78016-106)
78016-106-162024-05-09KLENLII HAND SOAP ANTIBACTERIAL (78016-106)
78016-106-182024-05-09KLENLII HAND SOAP ANTIBACTERIAL (78016-106)
78016-106-112024-01-30KLENLII HAND SOAP ANTIBACTERIAL (78016-106)
78016-106-122024-01-30KLENLII HAND SOAP ANTIBACTERIAL (78016-106)
78016-106-142024-01-30KLENLII HAND SOAP ANTIBACTERIAL (78016-106)
78016-106-162024-01-30KLENLII HAND SOAP ANTIBACTERIAL (78016-106)
78016-106-182024-01-30KLENLII HAND SOAP ANTIBACTERIAL (78016-106)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78016-106-11KLENLII HANDANTIBACTERIAL3785 mL in 1 JUGSOAP37854
78016-106-12KLENLII HANDANTIBACTERIAL59 mL in 1 BOTTLESOAP594
78016-106-14KLENLII HANDANTIBACTERIAL118 mL in 1 BOTTLESOAP1184
78016-106-16KLENLII HANDANTIBACTERIAL476 mL in 1 BOTTLESOAP4764
78016-106-18KLENLII HANDANTIBACTERIAL238 mL in 1 BOTTLESOAP2384

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78016-106KLENLII HAND ANTIBACTERIAL (CHLOROXYLENOL) SOAP [KLENLII COMPANY]4Legacy NDC, 5 package rows20240511_bb5f6bb3-c20c-4326-9b8d-ac7f7d2f4274.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
413261chloroxylenol 0.3 % Medicated Liquid SoapPSNbb5f6bb3-c20c-4326-9b8d-ac7f7d2f42744
413261chloroxylenol 3 MG/ML Medicated Liquid SoapSCDbb5f6bb3-c20c-4326-9b8d-ac7f7d2f42744
413261chloroxylenol 0.3 % Medicated Liquid SoapSYbb5f6bb3-c20c-4326-9b8d-ac7f7d2f42744

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78016-106-1678016010616476 mL in 1 BOTTLE (78016-106-16) 476 ml2020-06-140000-00-00NoNoCurrent