Package 0031-0100-08

Brand: robitussin maximum strength severe multi-symptom cough cold flu

Generic: acetaminophen, dextromethorphan hydrobromide, guaifenesin
NDC Package

Package Facts

Identity

Package NDC 0031-0100-08
Digits Only 0031010008
Product NDC 0031-0100
Description

1 BOTTLE in 1 CARTON (0031-0100-08) / 237 mL in 1 BOTTLE

Marketing

Marketing Status
Marketed Since 2024-02-15
Brand robitussin maximum strength severe multi-symptom cough cold flu
Generic acetaminophen, dextromethorphan hydrobromide, guaifenesin
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "43e64251-a916-1cb7-e063-6294a90a393a", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ"], "rxcui": ["2680300"], "spl_set_id": ["a6f750c8-8738-4965-a3ad-612c24611056"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0031-0100-04)  / 118 mL in 1 BOTTLE", "package_ndc": "0031-0100-04", "marketing_start_date": "20240215"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0031-0100-08)  / 237 mL in 1 BOTTLE", "package_ndc": "0031-0100-08", "marketing_start_date": "20240215"}], "brand_name": "Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu", "product_id": "0031-0100_43e64251-a916-1cb7-e063-6294a90a393a", "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": "0031-0100", "generic_name": "acetaminophen, dextromethorphan hydrobromide, guaifenesin", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/20mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/20mL"}, {"name": "GUAIFENESIN", "strength": "400 mg/20mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240215", "listing_expiration_date": "20261231"}