{
"NDC": {
"NDCCode": "13709-351-01",
"PackageDescription": "1 TUBE in 1 CARTON (13709-351-01) / 103.5 mL in 1 TUBE",
"NDC11Code": "13709-0351-01",
"ProductNDC": "13709-351",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Itch Relief",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Itch Relief Gel",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251126",
"EndMarketingDate": null,
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Neilmed Pharmaceuticals Inc.",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251126",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}