Kay Alcohol Foam Hand Sanitizer

Product NDC
63146-313
11-digit product format
631460313
Labeler code
63146
Product ID
63146-313_fd06b1a0-32f2-4d23-8e4c-f5b197d8c7ac
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63146-313DDiscontinued by firm2026-11-06
excluded packagepackage63146-31363146-313-09DDiscontinued 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
63146-313KAY ALCOHOL FOAM HAND SANITIZER (ALCOHOL) SOLUTION [KAY CHEMICAL COMPANY]3Legacy NDC20240823_435085a5-2e67-4dfa-999c-081911abf05f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63146-313-09631460313091200 mL in 1 BOTTLE (63146-313-09) 1200 ml2020-12-300000-00-00NoNoCurrent