mucus relief cold, flu and sore throat (76162-050)

Drug Facts

Product Profile

Brand Name mucus relief cold, flu and sore throat

Generic Name acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl

Labeler topco associates llc

Dosage Form SOLUTION

Routes

ORAL

Active Ingredients

acetaminophen 650 mg/20mL, dextromethorphan hydrobromide 20 mg/20mL, guaifenesin 400 mg/20mL, phenylephrine hydrochloride 10 mg/20mL

Manufacturer

TOPCO ASSOCIATES LLC

Identifiers & Regulatory

Product NDC 76162-050

Product ID 76162-050_56e39191-e11e-4b72-9755-3b9ab772b8be

Product Type HUMAN OTC DRUG

Marketing Category OTC MONOGRAPH DRUG

Application Number M012

Listing Expiration 2026-12-31

Marketing Start 2023-08-11

Pharmacologic Class

Established (EPC)

expectorant [epc]

Physiologic Effect

decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76162050

Hyphenated Format 76162-050

Supplemental Identifiers

RxCUI

1116572

UPC

0036800386167

UNII

362O9ITL9D 9D2RTI9KYH 495W7451VQ 04JA59TNSJ

NUI

N0000193956 N0000008867 N0000009560

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name mucus relief cold, flu and sore throat (source: ndc)

Generic Name acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl (source: ndc)

Application Number M012 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

650 mg/20mL
20 mg/20mL
400 mg/20mL
10 mg/20mL

source: ndc

Packaging

177 mL in 1 BOTTLE, PLASTIC (76162-050-45)

source: ndc

Packages (1)

76162-050-45 177 mL in 1 BOTTLE, PLASTIC (76162-050-45)

Ingredients (4)

acetaminophen (650 mg/20mL) dextromethorphan hydrobromide (20 mg/20mL) guaifenesin (400 mg/20mL) phenylephrine hydrochloride (10 mg/20mL)

Linked Drug Pages (1)

Mucus Relief Cold, Flu and Sore Throat ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "56e39191-e11e-4b72-9755-3b9ab772b8be", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0036800386167"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1116572"], "spl_set_id": ["6207ef50-4f28-4dbc-9a52-f44dd53d2a4f"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["TOPCO ASSOCIATES LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE, PLASTIC (76162-050-45)", "package_ndc": "76162-050-45", "marketing_start_date": "20230811"}], "brand_name": "Mucus Relief Cold, Flu and Sore Throat", "product_id": "76162-050_56e39191-e11e-4b72-9755-3b9ab772b8be", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic alpha1-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-1 Adrenergic Agonist [EPC]"], "product_ndc": "76162-050", "generic_name": "Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl", "labeler_name": "TOPCO ASSOCIATES LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Mucus Relief Cold, Flu and Sore Throat", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/20mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/20mL"}, {"name": "GUAIFENESIN", "strength": "400 mg/20mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/20mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230811", "listing_expiration_date": "20261231"}