KLENLII SANII WIPES

Product NDC: 78016-105
Requested package NDC: 78016-105-11
11-digit product format: 780160105
Labeler code: 78016
Product ID: 78016-105_d5d288db-d5b9-615b-e053-2995a90ad731
Type: HUMAN OTC DRUG
Nonproprietary name: ALCOHOL
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Klenlii Company
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-07-25
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 8 mL/1
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	78016-105	78016-105-11	I	Inactivated by FDA		2026-10-12

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 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	78016-105	78016-105-11	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#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
78016-105-11	2024-05-09	C162847	48780-1	1030e365-28f4-111a-e063-dadaa90a10e2	KLENLII SANII WIPES (75% ETHYL ALCOHOL) (78016-105)
78016-105-11	2024-01-30	C162847	48780-1	1030e365-28f4-111a-e063-dadaa90a10e2	KLENLII SANII WIPES (75% ETHYL ALCOHOL) (78016-105)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
78016-105-11	KLENLII SANII WIPES75 PERCENT	250 in 1 POUCH	SOLUTION	250		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78016-105	KLENLII SANII WIPES 75 PERCENT (ALCOHOL) SOLUTION [KLENLII COMPANY]	5	Legacy NDC, 1 package rows	20240511_1e77bb92-f0ea-442d-baa6-e582b18a8053.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3K9958V90M	ALCOHOL	64-17-5	ALCOHOL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
78016-105-11	78016010511	250 SOLUTION in 1 POUCH (78016-105-11)	250 solution	2020-07-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
KLENLII SANII WIPES (75% ETHYL ALCOHOL) (78016-105)	Klenlii Company	2024-05-09	HUMAN OTC DRUG LABEL	5