McD

Product NDC
63146-108
Requested package NDC
63146-108-10
11-digit product format
631460108
Labeler code
63146
Product ID
63146-108_64922822-2db3-4f7f-864a-80f33752b346
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
2007-08-17
Marketing end
0000-00-00
Substance
CHLOROXYLENOL
Active strength
1 mg/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 packagepackage63146-10863146-108-10DDiscontinued by firm2026-10-05

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 INGREDIENT0F32U78V2QMCD (CHLOROXYLENOL) SOLUTION [KAY CHEMICAL CO.]2
CHLOROXYLENOLACTIVE MOIETY0F32U78V2QMCD (CHLOROXYLENOL) SOLUTION [KAY CHEMICAL CO.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPMCD (CHLOROXYLENOL) SOLUTION [KAY CHEMICAL CO.]2
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUMCD (CHLOROXYLENOL) SOLUTION [KAY CHEMICAL CO.]2
FD&C RED NO. 4INACTIVE INGREDIENTX3W0AM1JLXMCD (CHLOROXYLENOL) SOLUTION [KAY CHEMICAL CO.]2
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MMCD (CHLOROXYLENOL) SOLUTION [KAY CHEMICAL CO.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMCD (CHLOROXYLENOL) SOLUTION [KAY CHEMICAL CO.]2
GLYCERYL MONOOLEATEINACTIVE INGREDIENT4PC054V79PMCD (CHLOROXYLENOL) SOLUTION [KAY CHEMICAL CO.]2
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75JMCD (CHLOROXYLENOL) SOLUTION [KAY CHEMICAL CO.]2
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNMCD (CHLOROXYLENOL) SOLUTION [KAY CHEMICAL CO.]2
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAMCD (CHLOROXYLENOL) SOLUTION [KAY CHEMICAL CO.]2
POTASSIUM COCOATEINACTIVE INGREDIENTF8U72V8ZXPMCD (CHLOROXYLENOL) SOLUTION [KAY CHEMICAL CO.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMCD (CHLOROXYLENOL) SOLUTION [KAY CHEMICAL CO.]2
SODIUM SULFATEINACTIVE INGREDIENT0YPR65R21JMCD (CHLOROXYLENOL) SOLUTION [KAY CHEMICAL CO.]2
WATERINACTIVE INGREDIENT059QF0KO0RMCD (CHLOROXYLENOL) SOLUTION [KAY CHEMICAL CO.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63146-108MCD (CHLOROXYLENOL) SOLUTION [KAY CHEMICAL COMPANY]7Legacy NDC20240817_eb89f2f1-eeae-4594-8ed8-8b166dfa3116.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63146-108-10631460108101250 mL in 1 BOTTLE, PLASTIC (63146-108-10) 1250 ml2007-08-170000-00-00NoNoCurrent