Home NDC 50580-446-01 EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY
Product NDC 50580-446
Requested package NDC 50580-446-01
11-digit product format 505800446
Labeler code 50580
Product ID 50580-446_3a1abd26-c0a9-8a65-e063-6294a90ab66e
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen and Dextromethorphan Hydrobromide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Kenvue Brands LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-08-26
Substance DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN
Active strength 15; 500 mg/1; mg/1
Pharmacologic classes Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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 EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 ACETAMINOPHEN 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 247324 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 50580-446-01 EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY 2 in 1 CARTON TABLET, FILM COATED 2 5 50580-446-01 EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY 12 in 1 BLISTER PACK TABLET, FILM COATED 12 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-446 EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY (ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, FILM COATED [KENVUE BRANDS LLC] 4 Current NDC, 2 package rows 20241109_1a17b24a-8022-4e2f-e063-6294a90af276.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 50580-446-01 50580044601 2 BLISTER PACK in 1 CARTON (50580-446-01) / 12 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2024-08-26 No No Current