Package 63102-120-16
Brand: actispec pse
Generic: dextromethorphan hydrobromide, guaifenesin, pseudoephedrine hydrochloridePackage Facts
Identity
Package NDC
63102-120-16
Digits Only
6310212016
Product NDC
63102-120
Description
473 mL in 1 BOTTLE (63102-120-16)
Marketing
Marketing Status
Brand
actispec pse
Generic
dextromethorphan hydrobromide, guaifenesin, pseudoephedrine hydrochloride
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "109b340a-cf73-4886-87d5-edf2702f6a2c", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ", "6V9V2RYJ8N"], "rxcui": ["1435143"], "spl_set_id": ["5def1555-87f4-41d5-8a5c-be560aa8f1e2"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["ACTIPHARMA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (63102-120-16)", "package_ndc": "63102-120-16", "marketing_start_date": "20250717"}], "brand_name": "ACTISPEC PSE", "product_id": "63102-120_109b340a-cf73-4886-87d5-edf2702f6a2c", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic alpha-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-Adrenergic Agonist [EPC]"], "product_ndc": "63102-120", "generic_name": "Dextromethorphan Hydrobromide, Guaifenesin, Pseudoephedrine Hydrochloride", "labeler_name": "ACTIPHARMA, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ACTISPEC PSE", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "187 mg/5mL"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "30 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250717", "listing_expiration_date": "20261231"}