Fortress

Product NDC
63146-105
11-digit product format
631460105
Labeler code
63146
Product ID
63146-105_535d840e-ac85-4a48-b489-462982efba1d
Type
HUMAN OTC DRUG
Nonproprietary name
Chloroxylenol
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Kay Chemical Co.
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2005-05-16
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63146-105DDiscontinued by firm2026-10-12
excluded packagepackage63146-10563146-105-03DDiscontinued by firm2026-10-12

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 INGREDIENT0F32U78V2QFORTRESS (CHLOROXYLENOL) SOLUTION [KAY CHEMCIAL CO.]1
CHLOROXYLENOLACTIVE MOIETY0F32U78V2QFORTRESS (CHLOROXYLENOL) SOLUTION [KAY CHEMCIAL CO.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPFORTRESS (CHLOROXYLENOL) SOLUTION [KAY CHEMCIAL CO.]1
DECYL GLUCOSIDEINACTIVE INGREDIENTZ17H97EA6YFORTRESS (CHLOROXYLENOL) SOLUTION [KAY CHEMCIAL CO.]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUFORTRESS (CHLOROXYLENOL) SOLUTION [KAY CHEMCIAL CO.]1
FD&C RED NO. 4INACTIVE INGREDIENTX3W0AM1JLXFORTRESS (CHLOROXYLENOL) SOLUTION [KAY CHEMCIAL CO.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MFORTRESS (CHLOROXYLENOL) SOLUTION [KAY CHEMCIAL CO.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXFORTRESS (CHLOROXYLENOL) SOLUTION [KAY CHEMCIAL CO.]1
GLYCERYL MONOOLEATEINACTIVE INGREDIENT4PC054V79PFORTRESS (CHLOROXYLENOL) SOLUTION [KAY CHEMCIAL CO.]1
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75JFORTRESS (CHLOROXYLENOL) SOLUTION [KAY CHEMCIAL CO.]1
LAURYL GLUCOSIDEINACTIVE INGREDIENT76LN7P7UCUFORTRESS (CHLOROXYLENOL) SOLUTION [KAY CHEMCIAL CO.]1
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNFORTRESS (CHLOROXYLENOL) SOLUTION [KAY CHEMCIAL CO.]1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAFORTRESS (CHLOROXYLENOL) SOLUTION [KAY CHEMCIAL CO.]1
POTASSIUM COCOATEINACTIVE INGREDIENTF8U72V8ZXPFORTRESS (CHLOROXYLENOL) SOLUTION [KAY CHEMCIAL CO.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFORTRESS (CHLOROXYLENOL) SOLUTION [KAY CHEMCIAL CO.]1
SODIUM SULFATEINACTIVE INGREDIENT0YPR65R21JFORTRESS (CHLOROXYLENOL) SOLUTION [KAY CHEMCIAL CO.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63146-105FORTRESS (CHLOROXYLENOL) SOLUTION [KAY CHEMICAL CO.]5Legacy NDC20240814_ebf6ee92-29fc-4923-a518-3f6d3ceec7cc.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63146-105-0363146010503750 mL in 1 BOTTLE, PLASTIC (63146-105-03) 750 ml2005-05-160000-00-00NoNoCurrent