{
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"PackageDescription": "20 mL in 1 BOTTLE (50991-540-20) ",
"NDC11Code": "50991-0540-20",
"ProductNDC": "50991-540",
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"ProprietaryName": "Duratuss Ac",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Codeine Phosphate, Dexbrompheniramine Maleate",
"DosageFormName": "LIQUID",
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"EndMarketingDate": null,
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Poly Pharmaceuticals, Inc.",
"SubstanceName": "CODEINE PHOSPHATE; DEXBROMPHENIRAMINE MALEATE",
"StrengthNumber": "10; 1",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2025-11-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250908",
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"SamplePackage": "N"
}
}