cough and chest congestion maximum strength

Generic: dextromethorphan hbr, guaifenesin

Labeler: genexa inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name cough and chest congestion maximum strength
Generic Name dextromethorphan hbr, guaifenesin
Labeler genexa inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 20 mg/20mL, guaifenesin 400 mg/20mL

Manufacturer
Genexa Inc.

Identifiers & Regulatory

Product NDC 69676-0077
Product ID 69676-0077_3857582e-3b04-90e9-e063-6294a90ab3d9
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-02-12

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 696760077
Hyphenated Format 69676-0077

Supplemental Identifiers

UPC
0850015736858
UNII
9D2RTI9KYH 495W7451VQ
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 cough and chest congestion maximum strength (source: ndc)
Generic Name dextromethorphan hbr, guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/20mL
  • 400 mg/20mL
source: ndc
Packaging
  • 177 mL in 1 BOTTLE, PLASTIC (69676-0077-9)
source: ndc

Packages (1)

Ingredients (2)

dextromethorphan hydrobromide (20 mg/20mL) guaifenesin (400 mg/20mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "3857582e-3b04-90e9-e063-6294a90ab3d9", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0850015736858"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "spl_set_id": ["e920b700-30d3-3266-e053-2a95a90a0639"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Genexa Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE, PLASTIC (69676-0077-9)", "package_ndc": "69676-0077-9", "marketing_start_date": "20240212"}], "brand_name": "Cough and Chest Congestion Maximum Strength", "product_id": "69676-0077_3857582e-3b04-90e9-e063-6294a90ab3d9", "dosage_form": "SUSPENSION", "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": "69676-0077", "generic_name": "Dextromethorphan HBr, Guaifenesin", "labeler_name": "Genexa Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cough and Chest Congestion Maximum Strength", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/20mL"}, {"name": "GUAIFENESIN", "strength": "400 mg/20mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240212", "listing_expiration_date": "20261231"}