QSR

Product NDC
63146-110
Requested package NDC
63146-110-02
11-digit product format
631460110
Labeler code
63146
Product ID
63146-110_4cf546dc-9fca-49f8-a557-46a319a3bbff
Type
HUMAN OTC DRUG
Nonproprietary name
Chloroxylenol
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Kay Chemical Company
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2009-12-15
Marketing end
0000-00-00
Substance
CHLOROXYLENOL
Active strength
5 mg/mL
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 packagepackage63146-11063146-110-02DDiscontinued by firm2026-11-06

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ChloroxylenolACTIVE INGREDIENT0F32U78V2QQSR ANTIBACTERIAL HAND SOAP (ANTISEPTIC HANDWASH) SOLUTION [KAY CHEMICAL COMPANY]1
ChloroxylenolACTIVE MOIETY0F32U78V2QQSR ANTIBACTERIAL HAND SOAP (ANTISEPTIC HANDWASH) SOLUTION [KAY CHEMICAL COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63146-110QSR (CHLOROXYLENOL) SOLUTION [KAY CHEMICAL COMPANY]4Legacy NDC20240817_9d6c9904-d8aa-46c8-b857-6372885f1d19.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63146-110-0263146011002800 mL in 1 BAG (63146-110-02) 800 ml2009-12-150000-00-00NoNoCurrent