guaifed dm

Generic: dextromethorphan, guaifenesin

Labeler: aldama pharmaceuticals, inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name guaifed dm
Generic Name dextromethorphan, guaifenesin
Labeler aldama pharmaceuticals, inc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

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

Manufacturer
Aldama Pharmaceuticals, Inc

Identifiers & Regulatory

Product NDC 73564-802
Product ID 73564-802_412081b0-9c2a-5df8-e063-6294a90a05c1
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-07-01

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 73564802
Hyphenated Format 73564-802

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

Resolved Composition

Strengths
  • 20 mg/10mL
  • 200 mg/10mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE (73564-802-04)
  • 237 mL in 1 BOTTLE (73564-802-08)
  • 473 mL in 1 BOTTLE (73564-802-16)
source: ndc

Packages (3)

73564-802-04 118 mL in 1 BOTTLE (73564-802-04) 73564-802-08 237 mL in 1 BOTTLE (73564-802-08) 73564-802-16 473 mL in 1 BOTTLE (73564-802-16)

Ingredients (2)

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

Linked Drug Pages (1)

Guaifed DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "412081b0-9c2a-5df8-e063-6294a90a05c1", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["996520"], "spl_set_id": ["396bf716-0f61-9563-e063-6394a90a171b"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Aldama Pharmaceuticals, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (73564-802-04)", "package_ndc": "73564-802-04", "marketing_start_date": "20250701"}, {"sample": false, "description": "237 mL in 1 BOTTLE (73564-802-08)", "package_ndc": "73564-802-08", "marketing_start_date": "20250701"}, {"sample": false, "description": "473 mL in 1 BOTTLE (73564-802-16)", "package_ndc": "73564-802-16", "marketing_start_date": "20250701"}], "brand_name": "Guaifed DM", "product_id": "73564-802_412081b0-9c2a-5df8-e063-6294a90a05c1", "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": "73564-802", "generic_name": "Dextromethorphan, Guaifenesin", "labeler_name": "Aldama Pharmaceuticals, Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifed DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/10mL"}, {"name": "GUAIFENESIN", "strength": "200 mg/10mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250701", "listing_expiration_date": "20261231"}