{
"NDC": {
"NDCCode": "87786-021-01",
"PackageDescription": "30 mL in 1 BOTTLE (87786-021-01) ",
"NDC11Code": "87786-0021-01",
"ProductNDC": "87786-021",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dravynor Balanitis Relief Cream",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Miconazole Nitrate 2% Balanitis Relief Cream",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260716",
"EndMarketingDate": null,
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M005",
"LabelerName": "Wenzhou Yuyuan Pharmaceutical Co., Ltd.",
"SubstanceName": "MICONAZOLE NITRATE",
"StrengthNumber": "2",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260716",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}