guaifenesin dm

Generic: dextromethorphan hydrobromide,guaifenesin

Labeler: innovida pharmaeutique corporation
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name guaifenesin dm
Generic Name dextromethorphan hydrobromide,guaifenesin
Labeler innovida pharmaeutique corporation
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

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

Manufacturer
Innovida Pharmaeutique Corporation

Identifiers & Regulatory

Product NDC 71800-057
Product ID 71800-057_312ea999-0543-99ea-e063-6294a90ae29e
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-03-20

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 71800057
Hyphenated Format 71800-057

Supplemental Identifiers

RxCUI
996520
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 guaifenesin dm (source: ndc)
Generic Name dextromethorphan hydrobromide,guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
  • 100 mg/5mL
source: ndc
Packaging
  • 119 mL in 1 BOTTLE (71800-057-05)
source: ndc

Packages (1)

71800-057-05 119 mL in 1 BOTTLE (71800-057-05)

Ingredients (2)

dextromethorphan hydrobromide (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": "312ea999-0543-99ea-e063-6294a90ae29e", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["996520"], "spl_set_id": ["dd3f806b-2470-4055-94e1-18adac811025"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Innovida Pharmaeutique Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "119 mL in 1 BOTTLE (71800-057-05)", "package_ndc": "71800-057-05", "marketing_start_date": "20250320"}], "brand_name": "Guaifenesin DM", "product_id": "71800-057_312ea999-0543-99ea-e063-6294a90ae29e", "dosage_form": "LIQUID", "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": "71800-057", "generic_name": "DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN", "labeler_name": "Innovida Pharmaeutique Corporation", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "100 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250320", "listing_expiration_date": "20261231"}