McD

Product NDC
63146-108
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63146-108DDiscontinued by firm2026-10-05
excluded packagepackage63146-10863146-108-03DDiscontinued by firm2026-10-05
excluded packagepackage63146-10863146-108-10DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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