Package 50991-142-16

Brand: duratuss dm

Generic: dexbrompheniramine maleate, dextromethorphan hydrobromide and pseudoephedrine hydrochloride
NDC Package

Package Facts

Identity

Package NDC 50991-142-16
Digits Only 5099114216
Product NDC 50991-142
Description

473 mL in 1 BOTTLE (50991-142-16)

Marketing

Marketing Status
Marketed Since 2025-10-15
Brand duratuss dm
Generic dexbrompheniramine maleate, dextromethorphan hydrobromide and pseudoephedrine hydrochloride
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "413a3951-d703-f14b-e063-6394a90a06dc", "openfda": {"upc": ["0350991142167"], "unii": ["BPA9UT29BS", "9D2RTI9KYH", "6V9V2RYJ8N"], "rxcui": ["2727430"], "spl_set_id": ["413a3951-d704-f14b-e063-6394a90a06dc"], "manufacturer_name": ["Poly Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (50991-142-16)", "package_ndc": "50991-142-16", "marketing_start_date": "20251015"}, {"sample": false, "description": "20 mL in 1 BOTTLE (50991-142-20)", "package_ndc": "50991-142-20", "marketing_start_date": "20251015"}], "brand_name": "DURATUSS DM", "product_id": "50991-142_413a3951-d703-f14b-e063-6394a90a06dc", "dosage_form": "LIQUID", "pharm_class": ["Adrenergic alpha-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-Adrenergic Agonist [EPC]"], "product_ndc": "50991-142", "generic_name": "Dexbrompheniramine Maleate, Dextromethorphan Hydrobromide and Pseudoephedrine Hydrochloride", "labeler_name": "Poly Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DURATUSS", "brand_name_suffix": "DM", "active_ingredients": [{"name": "DEXBROMPHENIRAMINE MALEATE", "strength": "1 mg/5mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/5mL"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "30 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20251015", "listing_expiration_date": "20261231"}