Home NDC 50090-5469 TYLENOL EXTRA STRENGTH
Product NDC 50090-5469
11-digit product format 500905469
Labeler code 50090
Product ID 50090-5469_72fb757a-ac68-4800-bdc0-ace18841ef75
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler A-S Medication Solutions
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-08-19
Substance ACETAMINOPHEN
Active strength 500 mg/1
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/1
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 198440 Internal RxNorm lookup 209459 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-5469-0 TYLENOL EXTRA STRENGTH 1 in 1 CARTON TABLET, FILM COATED 1 9 50090-5469-0 TYLENOL EXTRA STRENGTH 24 in 1 BOTTLE TABLET, FILM COATED 24 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-5469 TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] 9 Current NDC, Legacy NDC, 2 package rows 20240518_bcb7eb24-16cb-439e-879f-48d2f5e8ba83.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 50090-5469-0 50090546900 1 BOTTLE in 1 CARTON (50090-5469-0) / 24 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2021-02-17 0000-00-00 No No Current