55758-520-08 : NDC 2026 Code

55758-520-08 : Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride ( Broncolito )

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NDC Code : 55758-520-08 – JSON Data Format

                
{
  "NDC": {
    "NDCCode": "55758-520-08",
    "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (55758-520-08)  / 237 mL in 1 BOTTLE, PLASTIC",
    "NDC11Code": "55758-0520-08",
    "ProductNDC": "55758-520",
    "ProductTypeName": "HUMAN OTC DRUG",
    "ProprietaryName": "Broncolito",
    "ProprietaryNameSuffix": "Children",
    "NonProprietaryName": "Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride",
    "DosageFormName": "SYRUP",
    "RouteName": "ORAL",
    "StartMarketingDate": "20260701",
    "EndMarketingDate": null,
    "MarketingCategoryName": "OTC MONOGRAPH DRUG",
    "ApplicationNumber": "M012",
    "LabelerName": "Pharmadel LLC",
    "SubstanceName": "GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE",
    "StrengthNumber": "5; 50; 2.5",
    "StrengthUnit": "mg/2.5mL; mg/2.5mL; mg/2.5mL",
    "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
    "DEASchedule": null,
    "Status": "Active",
    "LastUpdate": "2026-07-01",
    "PackageNdcExcludeFlag": "N",
    "ProductNdcExcludeFlag": "N",
    "ListingRecordCertifiedThrough": "20271231",
    "StartMarketingDatePackage": "20260701",
    "EndMarketingDatePackage": null,
    "SamplePackage": "N"
  }
}