childrens cough and chest congestion

Generic: dextromethorphan hbr, guaifenesin

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

Drug Facts

Product Profile

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

dextromethorphan hydrobromide 5 mg/5mL, guaifenesin 100 mg/5mL

Manufacturer
Genexa Inc.

Identifiers & Regulatory

Product NDC 69676-0070
Product ID 69676-0070_2d95d5a4-34dd-e195-e063-6394a90a39da
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2022-09-01

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 696760070
Hyphenated Format 69676-0070

Supplemental Identifiers

UPC
0850015736018
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 childrens cough and chest congestion (source: ndc)
Generic Name dextromethorphan hbr, guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
  • 100 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (69676-0070-9) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

69676-0070-9 1 BOTTLE in 1 CARTON (69676-0070-9) / 118 mL in 1 BOTTLE

Ingredients (2)

dextromethorphan hydrobromide (5 mg/5mL) guaifenesin (100 mg/5mL)

Linked Drug Pages (1)

Childrens Cough and Chest Congestion ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2d95d5a4-34dd-e195-e063-6394a90a39da", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0850015736018"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "spl_set_id": ["2d95d5a4-34dc-e195-e063-6394a90a39da"], "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 in 1 CARTON (69676-0070-9)  / 118 mL in 1 BOTTLE", "package_ndc": "69676-0070-9", "marketing_start_date": "20220901"}], "brand_name": "Childrens Cough and Chest Congestion", "product_id": "69676-0070_2d95d5a4-34dd-e195-e063-6394a90a39da", "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": "69676-0070", "generic_name": "Dextromethorphan HBr, Guaifenesin", "labeler_name": "Genexa Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens 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": "20220901", "listing_expiration_date": "20261231"}