Package 50991-132-16
Brand: polytussin dm
Generic: dextromethorphan hbr, phenylephrine hcl, pyrilamine maleatePackage Facts
Identity
Package NDC
50991-132-16
Digits Only
5099113216
Product NDC
50991-132
Description
480 mL in 1 BOTTLE (50991-132-16)
Marketing
Marketing Status
Brand
polytussin dm
Generic
dextromethorphan hbr, phenylephrine hcl, pyrilamine maleate
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "46518fef-1086-bff6-e063-6394a90a7e9f", "openfda": {"upc": ["0350991132168"], "unii": ["9D2RTI9KYH", "04JA59TNSJ", "R35D29L3ZA"], "rxcui": ["2639753"], "spl_set_id": ["fda8f594-82bf-1781-e053-6294a90ad344"], "manufacturer_name": ["Poly Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 mL in 1 BOTTLE (50991-132-15)", "package_ndc": "50991-132-15", "marketing_start_date": "20230608"}, {"sample": false, "description": "480 mL in 1 BOTTLE (50991-132-16)", "package_ndc": "50991-132-16", "marketing_start_date": "20230608"}], "brand_name": "Polytussin DM", "product_id": "50991-132_46518fef-1086-bff6-e063-6394a90a7e9f", "dosage_form": "SYRUP", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "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]"], "product_ndc": "50991-132", "generic_name": "Dextromethorphan HBr, Phenylephrine HCl, Pyrilamine Maleate", "labeler_name": "Poly Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Polytussin DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "7.5 mg/5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/5mL"}, {"name": "PYRILAMINE MALEATE", "strength": "12.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230608", "listing_expiration_date": "20261231"}