Package 53145-323-04

Brand: adult bisolvine adult

Generic: guaifenesin, dextromethorphan
NDC Package

Package Facts

Identity

Package NDC 53145-323-04
Digits Only 5314532304
Product NDC 53145-323
Description

120 mL in 1 BOTTLE, PLASTIC (53145-323-04)

Marketing

Marketing Status
Marketed Since 2025-05-01
Brand adult bisolvine adult
Generic guaifenesin, dextromethorphan
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "3d3520bc-498c-922f-e063-6394a90a9a62", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["996520"], "spl_set_id": ["8cde5e39-a338-45af-b847-3823627f29c5"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["MENPER DISTRIBUTORS INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE, PLASTIC (53145-323-04)", "package_ndc": "53145-323-04", "marketing_start_date": "20250501"}], "brand_name": "Adult Bisolvine Adult", "product_id": "53145-323_3d3520bc-498c-922f-e063-6394a90a9a62", "dosage_form": "LIQUID", "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": "53145-323", "generic_name": "Guaifenesin, Dextromethorphan", "labeler_name": "MENPER DISTRIBUTORS INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Adult Bisolvine", "brand_name_suffix": "Adult", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/10mL"}, {"name": "GUAIFENESIN", "strength": "200 mg/10mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250501", "listing_expiration_date": "20261231"}