dextromethorphan hydrobromide and guaifenesin (69729-040)

Drug Facts

Product Profile

Brand Name dextromethorphan hydrobromide and guaifenesin

Generic Name dextromethorphan hydrobromide and guaifenesin

Labeler opmx llc

Dosage Form SYRUP

Routes

ORAL

Active Ingredients

dextromethorphan hydrobromide 20 mg/5mL, guaifenesin 300 mg/5mL

Manufacturer

OPMX LLC

Identifiers & Regulatory

Product NDC 69729-040

Product ID 69729-040_352f8de3-8fe0-4098-e063-6294a90ace4d

Product Type HUMAN OTC DRUG

Marketing Category OTC MONOGRAPH DRUG

Application Number M012

Listing Expiration 2026-12-31

Marketing Start 2021-02-01

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 69729040

Hyphenated Format 69729-040

Supplemental Identifiers

RxCUI

1117394

UPC

0810053180099 0810053180235 0856828008502

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 dextromethorphan hydrobromide and guaifenesin (source: ndc)

Generic Name dextromethorphan hydrobromide and guaifenesin (source: ndc)

Application Number M012 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

20 mg/5mL
300 mg/5mL

source: ndc

Packaging

118 mL in 1 BOTTLE (69729-040-04)

source: ndc

Packages (1)

69729-040-04 118 mL in 1 BOTTLE (69729-040-04)

Ingredients (2)

dextromethorphan hydrobromide (20 mg/5mL) guaifenesin (300 mg/5mL)

Linked Drug Pages (1)

DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "352f8de3-8fe0-4098-e063-6294a90ace4d", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0810053180099", "0810053180235", "0856828008502"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1117394"], "spl_set_id": ["826c2f47-00a6-4060-a7ad-1ef26ccfddd1"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["OPMX LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (69729-040-04)", "package_ndc": "69729-040-04", "marketing_start_date": "20210201"}], "brand_name": "DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN", "product_id": "69729-040_352f8de3-8fe0-4098-e063-6294a90ace4d", "dosage_form": "SYRUP", "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": "69729-040", "generic_name": "DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN", "labeler_name": "OPMX LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "300 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20210201", "listing_expiration_date": "20261231"}