guaifenesin dm

Generic: guaifenesin and dextromethorphan

Labeler: cardinal health 107, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name guaifenesin dm
Generic Name guaifenesin and dextromethorphan
Labeler cardinal health 107, llc
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

dextromethorphan 10 mg/5mL, guaifenesin 100 mg/5mL

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-5785
Product ID 55154-5785_b9d42a1e-4df9-4494-a773-8134907e1bf7
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 1992-07-01

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 551545785
Hyphenated Format 55154-5785

Supplemental Identifiers

RxCUI
996520
UPC
0055154578554
UNII
7355X3ROTS 495W7451VQ
NUI
N0000181821 N0000182149 N0000181819 N0000182147 N0000193956 N0000008867 N0000009560

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
  • 10 mg/5mL
  • 100 mg/5mL
source: ndc
Packaging
  • 5 CUP, UNIT-DOSE in 1 BAG (55154-5785-5) / 5 mL in 1 CUP, UNIT-DOSE
source: ndc

Packages (1)

55154-5785-5 5 CUP, UNIT-DOSE in 1 BAG (55154-5785-5) / 5 mL in 1 CUP, UNIT-DOSE

Ingredients (2)

dextromethorphan (10 mg/5mL) guaifenesin (100 mg/5mL)

Linked Drug Pages (1)

GUAIFENESIN DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b9d42a1e-4df9-4494-a773-8134907e1bf7", "openfda": {"nui": ["N0000181821", "N0000182149", "N0000181819", "N0000182147", "N0000193956", "N0000008867", "N0000009560"], "upc": ["0055154578554"], "unii": ["7355X3ROTS", "495W7451VQ"], "rxcui": ["996520"], "spl_set_id": ["9cfb1abb-98c4-4e90-8dd7-fcffc112f988"], "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": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "5 CUP, UNIT-DOSE in 1 BAG (55154-5785-5)  / 5 mL in 1 CUP, UNIT-DOSE", "package_ndc": "55154-5785-5", "marketing_start_date": "19920701"}], "brand_name": "GUAIFENESIN DM", "product_id": "55154-5785_b9d42a1e-4df9-4494-a773-8134907e1bf7", "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": "55154-5785", "generic_name": "GUAIFENESIN and DEXTROMETHORPHAN", "labeler_name": "Cardinal Health 107, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "GUAIFENESIN DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN", "strength": "10 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "100 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "19920701", "listing_expiration_date": "20261231"}