Package 0121-0638-00
Brand: guaifenesin dm
Generic: guaifenesin and dextromethorphanPackage Facts
Identity
Package NDC
0121-0638-00
Digits Only
0121063800
Product NDC
0121-0638
Description
10 TRAY in 1 CASE (0121-0638-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0638-05)
Marketing
Marketing Status
Brand
guaifenesin dm
Generic
guaifenesin and dextromethorphan
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "c50b4c5c-6f55-4118-a282-e0b490704e49", "openfda": {"nui": ["N0000181821", "N0000182149", "N0000181819", "N0000182147", "N0000193956", "N0000008867", "N0000009560"], "upc": ["0301210638046", "0301210638169"], "unii": ["7355X3ROTS", "495W7451VQ"], "rxcui": ["996520"], "spl_set_id": ["ff970fff-d1a3-4322-83b4-34e361431a1c"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Sigma-1 Agonist [EPC]", "Expectorant [EPC]"], "pharm_class_moa": ["Uncompetitive NMDA Receptor Antagonists [MoA]", "Sigma-1 Receptor Agonists [MoA]"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TRAY in 1 CASE (0121-0638-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0638-05)", "package_ndc": "0121-0638-00", "marketing_start_date": "19920701"}, {"sample": false, "description": "118 mL in 1 BOTTLE (0121-0638-04)", "package_ndc": "0121-0638-04", "marketing_start_date": "19920701"}, {"sample": false, "description": "237 mL in 1 BOTTLE (0121-0638-08)", "package_ndc": "0121-0638-08", "marketing_start_date": "19920701"}, {"sample": false, "description": "473 mL in 1 BOTTLE (0121-0638-16)", "package_ndc": "0121-0638-16", "marketing_start_date": "19920701"}], "brand_name": "GUAIFENESIN DM", "product_id": "0121-0638_c50b4c5c-6f55-4118-a282-e0b490704e49", "dosage_form": "SYRUP", "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": "0121-0638", "generic_name": "GUAIFENESIN and DEXTROMETHORPHAN", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN OTC DRUG", "brand_name_base": "GUAIFENESIN DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN", "strength": "10 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "100 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "19920701", "listing_expiration_date": "20261231"}