guaifenesin dm (60687-828)

Drug Facts

Product Profile

Brand Name guaifenesin dm

Generic Name guaifenesin and dextromethorphan

Labeler american health packaging

Dosage Form SYRUP

Routes

ORAL

Active Ingredients

dextromethorphan 20 mg/10mL, guaifenesin 200 mg/10mL

Manufacturer

American Health Packaging

Identifiers & Regulatory

Product NDC 60687-828

Product ID 60687-828_1d74f48d-1aa4-b779-e063-6394a90af176

Product Type HUMAN OTC DRUG

Marketing Category OTC MONOGRAPH DRUG

Application Number M012

Listing Expiration 2026-12-31

Marketing Start 2024-08-04

Pharmacologic Class

Established (EPC)

uncompetitive n-methyl-d-aspartate receptor antagonist [epc] sigma-1 agonist [epc] expectorant [epc]

Mechanism of Action

uncompetitive nmda receptor antagonists [moa] sigma-1 receptor agonists [moa]

Physiologic Effect

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60687828

Hyphenated Format 60687-828

Supplemental Identifiers

RxCUI

996520

UNII

7355X3ROTS 495W7451VQ

NUI

N0000181821 N0000182149 N0000181819 N0000182147 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 guaifenesin dm (source: ndc)

Generic Name guaifenesin and dextromethorphan (source: ndc)

Application Number M012 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

20 mg/10mL
200 mg/10mL

source: ndc

Packaging

10 TRAY in 1 CASE (60687-828-56) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-828-48) / 10 mL in 1 CUP, UNIT-DOSE (60687-828-42)

source: ndc

Packages (1)

60687-828-56 10 TRAY in 1 CASE (60687-828-56) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-828-48) / 10 mL in 1 CUP, UNIT-DOSE (60687-828-42)

Ingredients (2)

dextromethorphan (20 mg/10mL) guaifenesin (200 mg/10mL)

Linked Drug Pages (1)

Guaifenesin DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "1d74f48d-1aa4-b779-e063-6394a90af176", "openfda": {"nui": ["N0000181821", "N0000182149", "N0000181819", "N0000182147", "N0000193956", "N0000008867", "N0000009560"], "unii": ["7355X3ROTS", "495W7451VQ"], "rxcui": ["996520"], "spl_set_id": ["8632a655-7f5b-450f-95fa-62478a174e9c"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Sigma-1 Agonist [EPC]", "Expectorant [EPC]"], "pharm_class_moa": ["Uncompetitive NMDA Receptor Antagonists [MoA]", "Sigma-1 Receptor Agonists [MoA]"], "manufacturer_name": ["American Health Packaging"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TRAY in 1 CASE (60687-828-56)  / 10 CUP, UNIT-DOSE in 1 TRAY (60687-828-48)  / 10 mL in 1 CUP, UNIT-DOSE (60687-828-42)", "package_ndc": "60687-828-56", "marketing_start_date": "20240804"}], "brand_name": "Guaifenesin DM", "product_id": "60687-828_1d74f48d-1aa4-b779-e063-6394a90af176", "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": "60687-828", "generic_name": "Guaifenesin and Dextromethorphan", "labeler_name": "American Health Packaging", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN", "strength": "20 mg/10mL"}, {"name": "GUAIFENESIN", "strength": "200 mg/10mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240804", "listing_expiration_date": "20261231"}