{
"NDC": {
"NDCCode": "13709-346-01",
"PackageDescription": "1 TUBE in 1 CARTON (13709-346-01) / 25.5 g in 1 TUBE",
"NDC11Code": "13709-0346-01",
"ProductNDC": "13709-346",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cooling Gel",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Pain Relief Cooling Gel",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251113",
"EndMarketingDate": null,
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M015",
"LabelerName": "Neilmed Pharmaceuticals Inc.",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL",
"StrengthNumber": "2.5; 505",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2025-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251113",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}