Childrens Sudafed PE NASAL DECONGESTANT

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Childrens Sudafed PE NASAL DECONGESTANT
Generic name: PHENYLEPHRINE HYDROCHLORIDE
Manufacturer: Kenvue Brands LLC
Product type: HUMAN OTC DRUG
SPL set ID: 4dfd46e4-b9f9-464d-aa47-e8fa9e526a5d
SPL ID: 23506802-1f31-c967-e063-6394a90a2e7f
Version: 11
Effective date: 2024-11-04
Source export date: 2026-09-28
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:57:45

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		Childrens Sudafed PE NASAL DECONGESTANT	openfda.brand_name
generic name		PHENYLEPHRINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		Kenvue Brands LLC	openfda.manufacturer_name
ndc	package	50580-784-04	openfda.package_ndc
ndc	product	50580-784	openfda.product_ndc
ndc11	package	50580078404	derived:openfda.package_ndc
rxcui		692479	openfda.rxcui
spl id		23506802-1f31-c967-e063-6394a90a2e7f	id
spl set id		4dfd46e4-b9f9-464d-aa47-e8fa9e526a5d	set_id
unii		04JA59TNSJ	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Do not use in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if the child has heart disease high blood pressure thyroid disease diabetes a sodium-restricted diet When using this product do not exceed recommended dose Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.