kids cough and chest congestion
Generic: dextromethorphan hbr, guaifenesin
Labeler: genexa inc.Drug Facts
Product Profile
Brand Name
kids cough and chest congestion
Generic Name
dextromethorphan hbr, guaifenesin
Labeler
genexa inc.
Dosage Form
SUSPENSION
Routes
Active Ingredients
dextromethorphan hydrobromide 5 mg/5mL, guaifenesin 100 mg/5mL
Manufacturer
Identifiers & Regulatory
Product NDC
69676-0037
Product ID
69676-0037_3b51266b-c0ac-8626-e063-6394a90a274d
Product Type
HUMAN OTC DRUG
Marketing Category
OTC MONOGRAPH DRUG
Application Number
M012
Listing Expiration
2026-12-31
Marketing Start
2025-04-08
Pharmacologic Class
Established (EPC)
Physiologic Effect
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
696760037
Hyphenated Format
69676-0037
Supplemental Identifiers
UPC
UNII
NUI
Packaging Origin
Original Packager
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
kids cough and chest congestion (source: ndc)
Generic Name
dextromethorphan hbr, guaifenesin (source: ndc)
Application Number
M012 (source: ndc)
Routes
source: ndc
Resolved Composition
Strengths
- 5 mg/5mL
- 100 mg/5mL
Packaging
- 1 BOTTLE, PLASTIC in 1 CARTON (69676-0037-9) / 118 mL in 1 BOTTLE, PLASTIC
Packages (1)
Ingredients (2)
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "3b51266b-c0ac-8626-e063-6394a90a274d", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0850015736018"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "spl_set_id": ["a7ab2140-de09-158f-e053-2a95a90a25a0"], "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": "1 BOTTLE, PLASTIC in 1 CARTON (69676-0037-9) / 118 mL in 1 BOTTLE, PLASTIC", "package_ndc": "69676-0037-9", "marketing_start_date": "20250408"}], "brand_name": "Kids Cough and Chest Congestion", "product_id": "69676-0037_3b51266b-c0ac-8626-e063-6394a90a274d", "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": "69676-0037", "generic_name": "Dextromethorphan HBr, Guaifenesin", "labeler_name": "Genexa Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Kids Cough and Chest Congestion", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "5 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "100 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250408", "listing_expiration_date": "20261231"}