Home NDC 83324-054 Sinus Congestion
Product NDC 83324-054
11-digit product format 833240054
Labeler code 83324
Product ID 83324-054_c5436fc7-acd2-40c8-9607-55fcb5406ee7
Type HUMAN OTC DRUG
Nonproprietary name Pseudoephedrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Chain Drug Marketing Association, Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-11-07
Substance PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength 30 mg/1
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 Sinus Congestion
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049160 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 83324-054-24 Sinus Congestion 24 in 1 BLISTER PACK TABLET, FILM COATED 24 2 83324-054-24 Sinus Congestion 1 in 1 CARTON TABLET, FILM COATED 1 2 83324-054-48 Sinus Congestion 2 in 1 CARTON TABLET, FILM COATED 2 2 83324-054-48 Sinus Congestion 24 in 1 BLISTER PACK TABLET, FILM COATED 24 2
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 73 of 178 · 3,551 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 83324-054-24 83324005424 1 BLISTER PACK in 1 CARTON (83324-054-24) / 24 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2025-11-07 No No Current 83324-054-48 83324005448 2 BLISTER PACK in 1 CARTON (83324-054-48) / 24 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2025-11-07 No No Current