Home NDC 50580-784 Childrens Sudafed PE
Product NDC 50580-784
11-digit product format 505800784
Labeler code 50580
Product ID 50580-784_23506802-1f31-c967-e063-6394a90a2e7f
Type HUMAN OTC DRUG
Nonproprietary name Phenylephrine hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Kenvue Brands LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2008-10-01
Substance PHENYLEPHRINE HYDROCHLORIDE
Active strength 2.5 mg/5mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Childrens Sudafed PE
Brand name suffix NASAL DECONGESTANT
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 692479 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50580-784-04 Childrens Sudafed PENASAL DECONGESTANT 1 in 1 CARTON SOLUTION 1 11 50580-784-04 Childrens Sudafed PENASAL DECONGESTANT 118 mL in 1 BOTTLE SOLUTION 118 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Phenylephrine hydrochloride ACTIVE INGREDIENT 04JA59TNSJ CHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3 phenylephrine ACTIVE MOIETY 1WS297W6MV CHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL CHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3 carboxymethylcellulose sodium, unspecified form INACTIVE INGREDIENT K679OBS311 CHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3 edetate disodium INACTIVE INGREDIENT 7FLD91C86K CHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3 FD&C red No. 40 INACTIVE INGREDIENT WZB9127XOA CHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3 glycerin INACTIVE INGREDIENT PDC6A3C0OX CHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU CHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR CHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3 sorbitol INACTIVE INGREDIENT 506T60A25R CHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3 sucralose INACTIVE INGREDIENT 96K6UQ3ZD4 CHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3 water INACTIVE INGREDIENT 059QF0KO0R CHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-784 CHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KENVUE BRANDS LLC] 11 Current NDC, Legacy NDC, 2 package rows 20241115_4dfd46e4-b9f9-464d-aa47-e8fa9e526a5d.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50580-784-04 50580078404 1 BOTTLE in 1 CARTON (50580-784-04) / 118 mL in 1 BOTTLE 1 bottle 2008-10-01 0000-00-00 No No Current