dometuss

Generic: chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride

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

Drug Facts

Product Profile

Brand Name dometuss
Generic Name chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride
Labeler domel laboratories
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

chlorpheniramine maleate 2 mg/5mL, dextromethorphan hydrobromide 10 mg/5mL, phenylephrine hydrochloride 5 mg/5mL

Manufacturer
Domel Laboratories

Identifiers & Regulatory

Product NDC 53809-222
Product ID 53809-222_897f949d-5437-4419-a6c3-206778dbf45d
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-03-06

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc] sigma-1 agonist [epc] sigma-1 receptor agonists [moa] uncompetitive n-methyl-d-aspartate receptor antagonist [epc] uncompetitive nmda receptor antagonists [moa] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53809222
Hyphenated Format 53809-222

Supplemental Identifiers

RxCUI
1363752
UPC
0053809222043
UNII
V1Q0O9OJ9Z 9D2RTI9KYH 04JA59TNSJ

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 (source: ndc)
Generic Name chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/5mL
  • 10 mg/5mL
  • 5 mg/5mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE (53809-222-04)
source: ndc

Packages (1)

53809-222-04 118 mL in 1 BOTTLE (53809-222-04)

Ingredients (3)

chlorpheniramine maleate (2 mg/5mL) dextromethorphan hydrobromide (10 mg/5mL) phenylephrine hydrochloride (5 mg/5mL)

Linked Drug Pages (1)

DOMETUSS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "897f949d-5437-4419-a6c3-206778dbf45d", "openfda": {"upc": ["0053809222043"], "unii": ["V1Q0O9OJ9Z", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1363752"], "spl_set_id": ["3ebfc62f-27f6-48b2-9bae-bdefbd1d05fe"], "manufacturer_name": ["Domel Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (53809-222-04)", "package_ndc": "53809-222-04", "marketing_start_date": "20240306"}], "brand_name": "DOMETUSS", "product_id": "53809-222_897f949d-5437-4419-a6c3-206778dbf45d", "dosage_form": "LIQUID", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "53809-222", "generic_name": "chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride", "labeler_name": "Domel Laboratories", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DOMETUSS", "active_ingredients": [{"name": "CHLORPHENIRAMINE MALEATE", "strength": "2 mg/5mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240306", "listing_expiration_date": "20261231"}