childrens sudafed pe cold plus cough

Generic: dextromethorphan hydrobromide and phenylephrine hydrochloride

Labeler: kenvue brands llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name childrens sudafed pe cold plus cough
Generic Name dextromethorphan hydrobromide and phenylephrine hydrochloride
Labeler kenvue brands llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 5 mg/5mL, phenylephrine hydrochloride 2.5 mg/5mL

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-785
Product ID 50580-785_23508e92-0823-8827-e063-6394a90aeb9d
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2008-10-01

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] 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 50580785
Hyphenated Format 50580-785

Supplemental Identifiers

RxCUI
1544873
UNII
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 childrens sudafed pe cold plus cough (source: ndc)
Generic Name dextromethorphan hydrobromide and phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
  • 2.5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (50580-785-04) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

50580-785-04 1 BOTTLE in 1 CARTON (50580-785-04) / 118 mL in 1 BOTTLE

Ingredients (2)

dextromethorphan hydrobromide (5 mg/5mL) phenylephrine hydrochloride (2.5 mg/5mL)

Linked Drug Pages (1)

Childrens SUDAFED PE Cold plus Cough ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "23508e92-0823-8827-e063-6394a90aeb9d", "openfda": {"unii": ["9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1544873"], "spl_set_id": ["20e45243-3989-413a-bcf1-49d754ff2e44"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-785-04)  / 118 mL in 1 BOTTLE", "package_ndc": "50580-785-04", "marketing_start_date": "20081001"}], "brand_name": "Childrens SUDAFED PE Cold plus Cough", "product_id": "50580-785_23508e92-0823-8827-e063-6394a90aeb9d", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "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": "50580-785", "generic_name": "Dextromethorphan hydrobromide and Phenylephrine hydrochloride", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens SUDAFED PE Cold plus Cough", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "5 mg/5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "2.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20081001", "listing_expiration_date": "20261231"}