ANTIMICROBIAL CLEANSER

Product NDC
54057-524
11-digit product format
540570524
Labeler code
54057
Product ID
54057-524_faeb5c8e-d956-4ad4-a4ef-6f5b5443e97f
Type
HUMAN OTC DRUG
Nonproprietary name
CHLOROXYLENOL
Dosage form
SOAP
Route
TOPICAL
Labeler
AFFLAB, Affiliated Laboratories, a Division of AFFLINK
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-10-16
Marketing end
0000-00-00
Substance
CHLOROXYLENOL
Active strength
3 g/1000mL
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct54057-524IInactivated by FDA2026-10-05
excluded packagepackage54057-52454057-524-28IInactivated by FDA2026-10-05

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 · 44 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 packagepackage54057-524-28d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage54057-524-28f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage54057-524-282ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage54057-524-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage54057-524-28cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage54057-524-28cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage54057-524-28302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage54057-524-28ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage54057-524-280efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage54057-524-28ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage54057-524-28367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage54057-524-28557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage54057-524-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage54057-524-28834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage54057-524-281332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage54057-524-28fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage54057-524-2886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage54057-524-28bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage54057-524-288dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage54057-524-28e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage54057-524-289bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage54057-524-28110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54057-524-282019-11-27C16284748780-19855e2a2-3f4e-60a7-e053-dbdaa90a05bd3d2e19f3-bd99-47bd-a330-ded018e51f4b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54057-524-28ANTIMICROBIAL CLEANSER3785 mL in 1 BOTTLE, PLASTICSOAP37851

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLOROXYLENOLACTIVE INGREDIENT0F32U78V2QANTIMICROBIAL CLEANSER (CHLOROXYLENOL) SOAP [AFFLAB, AFFILIATED LABORATORIES, A DIVISION OF AFFLINK]1
CHLOROXYLENOLACTIVE MOIETY0F32U78V2QANTIMICROBIAL CLEANSER (CHLOROXYLENOL) SOAP [AFFLAB, AFFILIATED LABORATORIES, A DIVISION OF AFFLINK]1
C9-11 PARETH-6INACTIVE INGREDIENTKCE0V8JT7WANTIMICROBIAL CLEANSER (CHLOROXYLENOL) SOAP [AFFLAB, AFFILIATED LABORATORIES, A DIVISION OF AFFLINK]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPANTIMICROBIAL CLEANSER (CHLOROXYLENOL) SOAP [AFFLAB, AFFILIATED LABORATORIES, A DIVISION OF AFFLINK]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXANTIMICROBIAL CLEANSER (CHLOROXYLENOL) SOAP [AFFLAB, AFFILIATED LABORATORIES, A DIVISION OF AFFLINK]1
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWANTIMICROBIAL CLEANSER (CHLOROXYLENOL) SOAP [AFFLAB, AFFILIATED LABORATORIES, A DIVISION OF AFFLINK]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUANTIMICROBIAL CLEANSER (CHLOROXYLENOL) SOAP [AFFLAB, AFFILIATED LABORATORIES, A DIVISION OF AFFLINK]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSANTIMICROBIAL CLEANSER (CHLOROXYLENOL) SOAP [AFFLAB, AFFILIATED LABORATORIES, A DIVISION OF AFFLINK]1
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNANTIMICROBIAL CLEANSER (CHLOROXYLENOL) SOAP [AFFLAB, AFFILIATED LABORATORIES, A DIVISION OF AFFLINK]1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAANTIMICROBIAL CLEANSER (CHLOROXYLENOL) SOAP [AFFLAB, AFFILIATED LABORATORIES, A DIVISION OF AFFLINK]1
PEG-120 METHYL GLUCOSE DIOLEATEINACTIVE INGREDIENTYM0K64F20VANTIMICROBIAL CLEANSER (CHLOROXYLENOL) SOAP [AFFLAB, AFFILIATED LABORATORIES, A DIVISION OF AFFLINK]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ANTIMICROBIAL CLEANSER (CHLOROXYLENOL) SOAP [AFFLAB, AFFILIATED LABORATORIES, A DIVISION OF AFFLINK]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XANTIMICROBIAL CLEANSER (CHLOROXYLENOL) SOAP [AFFLAB, AFFILIATED LABORATORIES, A DIVISION OF AFFLINK]1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0ANTIMICROBIAL CLEANSER (CHLOROXYLENOL) SOAP [AFFLAB, AFFILIATED LABORATORIES, A DIVISION OF AFFLINK]1
WATERINACTIVE INGREDIENT059QF0KO0RANTIMICROBIAL CLEANSER (CHLOROXYLENOL) SOAP [AFFLAB, AFFILIATED LABORATORIES, A DIVISION OF AFFLINK]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54057-524ANTIMICROBIAL CLEANSER (CHLOROXYLENOL) SOAP [AFFLAB, AFFILIATED LABORATORIES, A DIVISION OF AFFLINK]1Legacy NDC, 1 package rows20131016_3d2e19f3-bd99-47bd-a330-ded018e51f4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
413261chloroxylenol 0.3 % Medicated Liquid SoapPSN3d2e19f3-bd99-47bd-a330-ded018e51f4b1
413261chloroxylenol 3 MG/ML Medicated Liquid SoapSCD3d2e19f3-bd99-47bd-a330-ded018e51f4b1
413261chloroxylenol 0.3 % Medicated Liquid SoapSY3d2e19f3-bd99-47bd-a330-ded018e51f4b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
54057-524-28540570524283785 mL in 1 BOTTLE, PLASTIC3785 mlHistorical