dometuss-dm

Generic: guaifenesin, dextromethorphan hbr

Labeler: domel laboratories
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name dometuss-dm
Generic Name guaifenesin, dextromethorphan hbr
Labeler domel laboratories
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 30 mg/5mL, guaifenesin 200 mg/5mL

Manufacturer
Domel Laboratories

Identifiers & Regulatory

Product NDC 53809-201
Product ID 53809-201_02354652-4696-45cc-94d0-d82092b0de8b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2016-01-21

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 53809201
Hyphenated Format 53809-201

Supplemental Identifiers

RxCUI
1147924
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 dometuss-dm (source: ndc)
Generic Name guaifenesin, dextromethorphan hbr (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/5mL
  • 200 mg/5mL
source: ndc
Packaging
  • 30 mL in 1 BOTTLE (53809-201-01)
  • 118 mL in 1 BOTTLE (53809-201-04)
source: ndc

Packages (2)

53809-201-01 30 mL in 1 BOTTLE (53809-201-01) 53809-201-04 118 mL in 1 BOTTLE (53809-201-04)

Ingredients (2)

dextromethorphan hydrobromide (30 mg/5mL) guaifenesin (200 mg/5mL)

Linked Drug Pages (1)

DOMETUSS-DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "02354652-4696-45cc-94d0-d82092b0de8b", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1147924"], "spl_set_id": ["7c4e7eca-0dc2-4b49-bda5-d61770ef9aca"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Domel Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 BOTTLE (53809-201-01)", "package_ndc": "53809-201-01", "marketing_start_date": "20160121"}, {"sample": false, "description": "118 mL in 1 BOTTLE (53809-201-04)", "package_ndc": "53809-201-04", "marketing_start_date": "20160121"}], "brand_name": "DOMETUSS-DM", "product_id": "53809-201_02354652-4696-45cc-94d0-d82092b0de8b", "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": "53809-201", "generic_name": "GUAIFENESIN, DEXTROMETHORPHAN HBr", "labeler_name": "Domel Laboratories", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DOMETUSS-DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "30 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "200 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20160121", "listing_expiration_date": "20261231"}