Package 35916-0759-4
Brand: guaifenesin,dextromethorphan hbr
Generic: guaifenesin,dextromethorphan hbrPackage Facts
Identity
Package NDC
35916-0759-4
Digits Only
3591607594
Product NDC
35916-0759
Description
2 BAG in 1 BOX (35916-0759-4) / 1500 CAPSULE, LIQUID FILLED in 1 BAG
Marketing
Marketing Status
Brand
guaifenesin,dextromethorphan hbr
Generic
guaifenesin,dextromethorphan hbr
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "48423b1b-a8c9-897b-e063-6294a90a3bba", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1661740"], "spl_set_id": ["3e5d978f-cc70-60a5-e063-6394a90a67d3"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Softgel Healthcare Pvt Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 POUCH in 1 BOX (35916-0759-3) / 2000 CAPSULE, LIQUID FILLED in 1 POUCH", "package_ndc": "35916-0759-3", "marketing_start_date": "20250915"}, {"sample": false, "description": "2 BAG in 1 BOX (35916-0759-4) / 1500 CAPSULE, LIQUID FILLED in 1 BAG", "package_ndc": "35916-0759-4", "marketing_start_date": "20260113"}], "brand_name": "Guaifenesin,Dextromethorphan Hbr", "product_id": "35916-0759_48423b1b-a8c9-897b-e063-6294a90a3bba", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["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]"], "product_ndc": "35916-0759", "generic_name": "Guaifenesin,Dextromethorphan Hbr", "labeler_name": "Softgel Healthcare Pvt Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin,Dextromethorphan Hbr", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/1"}, {"name": "GUAIFENESIN", "strength": "400 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250911", "listing_expiration_date": "20271231"}