Home NDC 54859-803 Conex Pediatric
Product NDC 54859-803
11-digit product format 548590803
Labeler code 54859
Product ID 54859-803_4745f618-0a3b-a9ae-e063-6394a90a5cf6
Type HUMAN OTC DRUG
Nonproprietary name Dexbrompheniramine Maleate, Pseudoephedrine HCl
Dosage form LIQUID
Route ORAL
Labeler Llorens Pharmaceutical International Division
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-12-01
Substance DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength 1; 30 mg/5mL; 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 Conex Pediatric
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXBROMPHENIRAMINE MALEATE 1 mg/5mL PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination BPA9UT29BS Internal UNII lookup 6V9V2RYJ8N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1299143 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 54859-803-16 Conex Pediatric 473 mL in 1 BOTTLE LIQUID 473 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54859-803 CONEX PEDIATRIC (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] 1 Current NDC, 1 package rows 20241228_2a46af43-ef36-e14e-e063-6394a90a8285.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 Sample Exclude flag Status 54859-803-16 54859080316 473 mL in 1 BOTTLE (54859-803-16) 473 ml 2024-12-01 No No Current