Home NDC 50580-209-04 TYLENOL Extra Strength
Product NDC 50580-209
Requested package NDC 50580-209-04
11-digit product format 505800209
Labeler code 50580
Product ID 50580-209_3efe12ef-7f94-9548-e063-6294a90aba91
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form POWDER
Route ORAL
Labeler Kenvue Brands LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-06-15
Substance ACETAMINOPHEN
Active strength 500 mg/.95g
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 TYLENOL Extra Strength
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/.95g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2374360 Internal RxNorm lookup 2374361 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 50580-209-02 TYLENOL Extra Strength 12 in 1 CARTON POWDER 12 7 50580-209-02 TYLENOL Extra Strength 0.95 g in 1 PACKET POWDER 0.95 7 50580-209-04 TYLENOL Extra Strength 32 in 1 CARTON POWDER 32 7 50580-209-04 TYLENOL Extra Strength 0.95 g in 1 PACKET POWDER 0.95 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-209 TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) POWDER [KENVUE BRANDS LLC] 6 Current NDC, Legacy NDC, 4 package rows 20241103_ab02080a-c903-4e4a-a9f3-2b8197ed2f2b.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 1 of 83 · 1,657 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 50580-209-04 50580020904 32 PACKET in 1 CARTON (50580-209-04) / .95 g in 1 PACKET 32 packet 2020-06-15 0000-00-00 No No Current