Kay QSR

Product NDC
63146-118
11-digit product format
631460118
Labeler code
63146
Product ID
63146-118_1b9c2a54-4ee9-42e6-a1f4-032b83e45b3d
Type
HUMAN OTC DRUG
Nonproprietary name
Triclosan
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Kay Chemical Co.
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-08-30
Marketing end
2023-03-03
Substance
TRICLOSAN
Active strength
0 mg/100mL
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct63146-118DDiscontinued by firm2026-10-05
excluded packagepackage63146-11863146-118-06DDiscontinued 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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63146-118-06d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63146-118-06f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63146-118-062ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63146-118-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63146-118-06cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63146-118-06cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63146-118-06302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63146-118-06ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63146-118-060efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63146-118-06ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63146-118-06367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63146-118-06557ba5c1ecfa…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
TRICLOSANACTIVE INGREDIENT4NM5039Y5XKAY QSR (TRICLOSAN) SOLUTION [KAY CHEMICAL CO.]1
TRICLOSANACTIVE MOIETY4NM5039Y5XKAY QSR (TRICLOSAN) SOLUTION [KAY CHEMICAL CO.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MKAY QSR (TRICLOSAN) SOLUTION [KAY CHEMICAL CO.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XKAY QSR (TRICLOSAN) SOLUTION [KAY CHEMICAL CO.]1
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4KAY QSR (TRICLOSAN) SOLUTION [KAY CHEMICAL CO.]1
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATEINACTIVE INGREDIENTH2KVQ74JM4KAY QSR (TRICLOSAN) SOLUTION [KAY CHEMICAL CO.]1
COCAMINE OXIDEINACTIVE INGREDIENTQWA2IZI6FIKAY QSR (TRICLOSAN) SOLUTION [KAY CHEMICAL CO.]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUKAY QSR (TRICLOSAN) SOLUTION [KAY CHEMICAL CO.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDKAY QSR (TRICLOSAN) SOLUTION [KAY CHEMICAL CO.]1
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75JKAY QSR (TRICLOSAN) SOLUTION [KAY CHEMICAL CO.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TKAY QSR (TRICLOSAN) SOLUTION [KAY CHEMICAL CO.]1
PEG-75 LANOLININACTIVE INGREDIENT09179OX7TBKAY QSR (TRICLOSAN) SOLUTION [KAY CHEMICAL CO.]1
POTASSIUM COCOATEINACTIVE INGREDIENTF8U72V8ZXPKAY QSR (TRICLOSAN) SOLUTION [KAY CHEMICAL CO.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHKAY QSR (TRICLOSAN) SOLUTION [KAY CHEMICAL CO.]1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0KAY QSR (TRICLOSAN) SOLUTION [KAY CHEMICAL CO.]1
WATERINACTIVE INGREDIENT059QF0KO0RKAY QSR (TRICLOSAN) SOLUTION [KAY CHEMICAL CO.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63146-118-06631460118061200 mL in 1 BOTTLE, PLASTIC (63146-118-06) 1200 ml2011-08-302023-03-03NoNoCurrent