{
"NDC": {
"NDCCode": "83778-012-01",
"PackageDescription": "6 mL in 1 BOTTLE (83778-012-01) ",
"NDC11Code": "83778-0012-01",
"ProductNDC": "83778-012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Teethwhitening Kit",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Teethwhitening Kit",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241214",
"EndMarketingDate": null,
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "Jiangxi Dentalbright Technology Co., Ltd.",
"SubstanceName": "PHTHALIMIDOPEROXYCAPROIC ACID; POTASSIUM CITRATE; TRIBASIC CALCIUM PHOSPHATE",
"StrengthNumber": "12; 3; 1",
"StrengthUnit": "g/100mL; g/100mL; g/100mL",
"Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2025-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241214",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}