Prestige

Product NDC
63621-400
11-digit product format
636210400
Labeler code
63621
Product ID
63621-400_9b44ad70-06c0-4634-b8d2-9329640244ec
Type
HUMAN OTC DRUG
Nonproprietary name
Chloroxylenol
Dosage form
SOAP
Route
TOPICAL
Labeler
Sunburst Chemicals, Inc.
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-05-02
Marketing end
2021-12-31
Substance
CHLOROXYLENOL
Active strength
10 mg/mL
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 productproduct63621-400DDiscontinued by firm2026-10-05
excluded packagepackage63621-40063621-400-14DDiscontinued 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 packagepackage63621-400-14d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63621-400-14f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63621-400-142ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63621-400-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63621-400-14cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63621-400-14cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63621-400-14302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63621-400-14ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63621-400-140efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63621-400-14ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63621-400-14367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63621-400-14557ba5c1ecfa…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 INGREDIENT0F32U78V2QPRESTIGE (CHLOROXYLENOL) SOAP [SUNBURST CHEMICALS, INC.]1
CHLOROXYLENOLACTIVE MOIETY0F32U78V2QPRESTIGE (CHLOROXYLENOL) SOAP [SUNBURST CHEMICALS, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPRESTIGE (CHLOROXYLENOL) SOAP [SUNBURST CHEMICALS, INC.]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUPRESTIGE (CHLOROXYLENOL) SOAP [SUNBURST CHEMICALS, INC.]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SPRESTIGE (CHLOROXYLENOL) SOAP [SUNBURST CHEMICALS, INC.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MPRESTIGE (CHLOROXYLENOL) SOAP [SUNBURST CHEMICALS, INC.]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302PRESTIGE (CHLOROXYLENOL) SOAP [SUNBURST CHEMICALS, INC.]1
LAURIC DIETHANOLAMIDEINACTIVE INGREDIENTI29I2VHG38PRESTIGE (CHLOROXYLENOL) SOAP [SUNBURST CHEMICALS, INC.]1
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)INACTIVE INGREDIENT0L414VCS5YPRESTIGE (CHLOROXYLENOL) SOAP [SUNBURST CHEMICALS, INC.]1
SODIUM C14-16 OLEFIN SULFONATEINACTIVE INGREDIENTO9W3D3YF5UPRESTIGE (CHLOROXYLENOL) SOAP [SUNBURST CHEMICALS, INC.]1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0PRESTIGE (CHLOROXYLENOL) SOAP [SUNBURST CHEMICALS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RPRESTIGE (CHLOROXYLENOL) SOAP [SUNBURST CHEMICALS, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63621-400-14636210400143785 mL in 1 BOTTLE, PLASTIC (63621-400-14) 3785 ml2014-05-022021-12-31NoNoCurrent