Home NDC 50580-536 Childrens Sudafed
Product NDC 50580-536
11-digit product format 505800536
Labeler code 50580
Product ID 50580-536_21732f4a-40b0-b486-e063-6394a90a1536
Type HUMAN OTC DRUG
Nonproprietary name Pseudoephedrine hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Kenvue Brands LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2008-10-01
Substance PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength 15 mg/5mL
Pharmacologic classes Adrenergic alpha-Agonists [MoA], alpha-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
Brand name suffix Nasal Decongestant
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PSEUDOEPHEDRINE HYDROCHLORIDE 15 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6V9V2RYJ8N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049143 Internal RxNorm lookup 1049770 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 50580-536-04 Childrens SudafedNasal Decongestant 118 mL in 1 BOTTLE SOLUTION 118 9 50580-536-04 Childrens SudafedNasal Decongestant 1 in 1 CARTON SOLUTION 1 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-536 CHILDRENS SUDAFED NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) SOLUTION [KENVUE BRANDS LLC] 9 Current NDC, Legacy NDC, 2 package rows 20241109_52e9307b-ad38-4f65-bb2f-4fa262e82010.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 50580-536-04 50580053604 1 BOTTLE in 1 CARTON (50580-536-04) / 118 mL in 1 BOTTLE 1 bottle 2008-10-01 0000-00-00 No No Current