Retail Foaming Alcohol Hand Sanitizer

Product NDC
63146-312
Requested package NDC
63146-312-09
11-digit product format
631460312
Labeler code
63146
Product ID
63146-312_5a60fab5-71f9-43f3-ae2a-f04bd4419fbe
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Kay Chemical Company
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-12-02
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
70 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 packagepackage63146-31263146-312-09DDiscontinued by firm2026-11-06

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63146-312RETAIL FOAMING ALCOHOL HAND SANITIZER (ALCOHOL) SOLUTION [KAY CHEMICAL COMPANY]3Legacy NDC20240823_8e7ff0be-1bdc-4c06-8296-628727bd24d3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63146-312-09631460312091200 mL in 1 BOTTLE (63146-312-09) 1200 ml2020-12-020000-00-00NoNoCurrent