Acute-Kare

Product NDC
11084-800
11-digit product format
110840800
Labeler code
11084
Product ID
11084-800_d8f6476c-9a7f-413e-9611-919da0dcbedc
Type
HUMAN OTC DRUG
Nonproprietary name
CHLOROXYLENOL
Dosage form
SOAP
Route
TOPICAL
Labeler
SC Johnson Professional USA, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-02-01
Marketing end
2027-12-31
Substance
CHLOROXYLENOL
Active strength
1 g/100mL
NDC exclude flag
No
Current FDA listing
Yes

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11084-80011084-800-13DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11084-80011084-800-13DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11084-80011084-800-13DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

Additional Listing Data#

Finished product
Yes
Brand name base
Acute-Kare
Brand name suffix
Healthcare Personnel Handwash

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLOROXYLENOL1 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0F32U78V2QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
413257Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
45e9e9dd-444b-46b1-a522-4ae372e6ff3cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11084-800-41Acute-KareHealthcare Personnel Handwash1000 mL in 1 BOTTLESOAP10006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11084-800ACUTE-KARE HEALTHCARE PERSONNEL HANDWASH (CHLOROXYLENOL) SOAP [SC JOHNSON PROFESSIONAL USA, INC.]5Current NDC, Legacy NDC, 1 package rows20241220_45e9e9dd-444b-46b1-a522-4ae372e6ff3c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acute-Kare Healthcare Personnel HandwashCHLOROXYLENOLSC Johnson Professional USA, Inc.45e9e9dd-444b-46b1-a522-4ae372e6ff3c2024-12-17WarningsExact identifier
ndc (product): 11084-800

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
413257chloroxylenol 1 % Medicated Liquid SoapPSN45e9e9dd-444b-46b1-a522-4ae372e6ff3c6
413257chloroxylenol 10 MG/ML Medicated Liquid SoapSCD45e9e9dd-444b-46b1-a522-4ae372e6ff3c6
413257chloroxylenol 1 % Medicated Liquid SoapSY45e9e9dd-444b-46b1-a522-4ae372e6ff3c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11084-800-1311084080013444 mL in 1 BOTTLE (11084-800-13) 444 ml2018-02-012022-01-01NoNoCurrent
11084-800-41110840800411000 mL in 1 BOTTLE (11084-800-41) 1000 ml2018-02-012027-12-31NoNoCurrent