FDA.reportPublic FDA data

PCMX with Emollient

Product NDC
52380-9957
11-digit product format
523809957
Labeler code
52380
Product ID
52380-9957_65a8bec7-b3b1-1919-e053-2991aa0a6540
Type
HUMAN OTC DRUG
Nonproprietary name
Chloroxylenol
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Aplicare Products, LLC.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2004-05-01
Marketing end
0000-00-00
Substance
CHLOROXYLENOL
Active strength
3 mg/100mL
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52380-9957-32020-01-31C16284748780-19d75b9d0-3c70-f424-e053-dadaa90a57cePCMX with Emollient
52380-9957-42020-01-31C16284748780-19d75b9d0-3c70-f424-e053-dadaa90a57cePCMX with Emollient
52380-9957-92020-01-31C16284748780-19d75b9d0-3c70-f424-e053-dadaa90a57cePCMX with Emollient

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52380-9957-3PCMX with Emollient946 mL in 1 BOTTLESOLUTION9465
52380-9957-4PCMX with Emollient118 mL in 1 BOTTLESOLUTION1185
52380-9957-9PCMX with Emollient208198 mL in 1 DRUMSOLUTION2081985

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ChloroxylenolACTIVE INGREDIENT0F32U78V2QPCMX WITH EMOLLIENT (CHLOROXYLENOL) SOLUTION [APLICARE, INC.]3
ChloroxylenolACTIVE MOIETY0F32U78V2QPCMX WITH EMOLLIENT (CHLOROXYLENOL) SOLUTION [APLICARE, INC.]3
Anhydrous Citric AcidINACTIVE INGREDIENTXF417D3PSLPCMX WITH EMOLLIENT (CHLOROXYLENOL) SOLUTION [APLICARE, INC.]3
PEG-120 Methyl Glucose DioleateINACTIVE INGREDIENTYM0K64F20VPCMX WITH EMOLLIENT (CHLOROXYLENOL) SOLUTION [APLICARE, INC.]3
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TPCMX WITH EMOLLIENT (CHLOROXYLENOL) SOLUTION [APLICARE, INC.]3
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3PCMX WITH EMOLLIENT (CHLOROXYLENOL) SOLUTION [APLICARE, INC.]3
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IPCMX WITH EMOLLIENT (CHLOROXYLENOL) SOLUTION [APLICARE, INC.]3
Sodium Lauroyl SarcosinateINACTIVE INGREDIENT632GS99618PCMX WITH EMOLLIENT (CHLOROXYLENOL) SOLUTION [APLICARE, INC.]3
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JPCMX WITH EMOLLIENT (CHLOROXYLENOL) SOLUTION [APLICARE, INC.]3
WaterINACTIVE INGREDIENT059QF0KO0RPCMX WITH EMOLLIENT (CHLOROXYLENOL) SOLUTION [APLICARE, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52380-9957PCMX WITH EMOLLIENT (CHLOROXYLENOL) SOLUTION [APLICARE PRODUCTS, LLC.]5Legacy NDC, 3 package rows20180220_9fc5ad9e-66cd-42e9-8bc8-43f44eee27a2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1045621chloroxylenol 3.3 % Medicated Liquid SoapPSN9fc5ad9e-66cd-42e9-8bc8-43f44eee27a25
1045621chloroxylenol 33 MG/ML Medicated Liquid SoapSCD9fc5ad9e-66cd-42e9-8bc8-43f44eee27a25
1045621chloroxylenol 3.3 % Medicated Liquid SoapSY9fc5ad9e-66cd-42e9-8bc8-43f44eee27a25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
52380-9957-352380995703946 mL in 1 BOTTLE946 mlHistorical
52380-9957-452380995704118 mL in 1 BOTTLE118 mlHistorical
52380-9957-952380995709208198 mL in 1 DRUM208198 mlHistorical