dometuss-da

Generic: chlorpheniramine maleate, phenylephrine hydrochloride

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

Drug Facts

Product Profile

Brand Name dometuss-da
Generic Name chlorpheniramine maleate, phenylephrine hydrochloride
Labeler domel laboratories
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

chlorpheniramine maleate 1 mg/5mL, phenylephrine hydrochloride 2.5 mg/5mL

Manufacturer
Domel Laboratories

Identifiers & Regulatory

Product NDC 53809-206
Product ID 53809-206_7ed906cf-a0da-450e-a245-2bb689dc997b
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

Classes
adrenergic alpha1-agonists [moa] histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53809206
Hyphenated Format 53809-206

Supplemental Identifiers

RxCUI
1429345
UNII
V1Q0O9OJ9Z 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-da (source: ndc)
Generic Name chlorpheniramine maleate, phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/5mL
  • 2.5 mg/5mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE (53809-206-04)
source: ndc

Packages (1)

53809-206-04 118 mL in 1 BOTTLE (53809-206-04)

Ingredients (2)

chlorpheniramine maleate (1 mg/5mL) phenylephrine hydrochloride (2.5 mg/5mL)

Linked Drug Pages (1)

DOMETUSS-DA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7ed906cf-a0da-450e-a245-2bb689dc997b", "openfda": {"unii": ["V1Q0O9OJ9Z", "04JA59TNSJ"], "rxcui": ["1429345"], "spl_set_id": ["b5def3fb-90b9-4b7e-bb22-745804b0566a"], "manufacturer_name": ["Domel Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (53809-206-04)", "package_ndc": "53809-206-04", "marketing_start_date": "20160121"}], "brand_name": "DOMETUSS-DA", "product_id": "53809-206_7ed906cf-a0da-450e-a245-2bb689dc997b", "dosage_form": "LIQUID", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "53809-206", "generic_name": "CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "Domel Laboratories", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DOMETUSS-DA", "active_ingredients": [{"name": "CHLORPHENIRAMINE MALEATE", "strength": "1 mg/5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "2.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20160121", "listing_expiration_date": "20261231"}