{
"NDC": {
"NDCCode": "85265-103-01",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (85265-103-01) / 100 mL in 1 BOTTLE, PUMP",
"NDC11Code": "85265-0103-01",
"ProductNDC": "85265-103",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Soteri Skin Long-term Eczema Relief Cream",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Colloidal Oatmeal",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251023",
"EndMarketingDate": null,
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Soteri Skin, Inc",
"SubstanceName": "OATMEAL",
"StrengthNumber": "1",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251023",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}