childrens sudafed pe nasal decongestant

Generic: 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 nasal decongestant
Generic Name phenylephrine hydrochloride
Labeler kenvue brands llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

phenylephrine hydrochloride 2.5 mg/5mL

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-784
Product ID 50580-784_23506802-1f31-c967-e063-6394a90a2e7f
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] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50580784
Hyphenated Format 50580-784

Supplemental Identifiers

RxCUI
692479
UPC
0300450537041
UNII
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 nasal decongestant (source: ndc)
Generic Name phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (50580-784-04) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

50580-784-04 1 BOTTLE in 1 CARTON (50580-784-04) / 118 mL in 1 BOTTLE

Ingredients (1)

phenylephrine hydrochloride (2.5 mg/5mL)

Linked Drug Pages (1)

Childrens Sudafed PE NASAL DECONGESTANT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "23506802-1f31-c967-e063-6394a90a2e7f", "openfda": {"upc": ["0300450537041"], "unii": ["04JA59TNSJ"], "rxcui": ["692479"], "spl_set_id": ["4dfd46e4-b9f9-464d-aa47-e8fa9e526a5d"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-784-04)  / 118 mL in 1 BOTTLE", "package_ndc": "50580-784-04", "marketing_start_date": "20081001"}], "brand_name": "Childrens Sudafed PE NASAL DECONGESTANT", "product_id": "50580-784_23506802-1f31-c967-e063-6394a90a2e7f", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "50580-784", "generic_name": "Phenylephrine hydrochloride", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Sudafed PE", "brand_name_suffix": "NASAL DECONGESTANT", "active_ingredients": [{"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "2.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20081001", "listing_expiration_date": "20261231"}