Home NDC 50580-378 Tylenol Extra Strength
Product NDC 50580-378
11-digit product format 505800378
Labeler code 50580
Product ID 50580-378_48dff3c9-329f-1300-e063-6294a90a47ef
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Kenvue Brands LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-11-01
Substance ACETAMINOPHEN
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
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 2027-12-31 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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50580-378-01 Tylenol Extra Strength 24 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 24 16 50580-378-01 Tylenol Extra Strength 1 in 1 CARTON TABLET, FILM COATED 1 16 50580-378-02 Tylenol Extra Strength 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 16 50580-378-02 Tylenol Extra Strength 1 in 1 CARTON TABLET, FILM COATED 1 16 50580-378-03 Tylenol Extra Strength 225 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 225 16 50580-378-04 Tylenol Extra Strength 1 in 1 CARTON TABLET, FILM COATED 1 16 50580-378-04 Tylenol Extra Strength 24 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 24 16 50580-378-05 Tylenol Extra Strength 50 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 50 16 50580-378-05 Tylenol Extra Strength 1 in 1 CARTON TABLET, FILM COATED 1 16 50580-378-06 Tylenol Extra Strength 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 16 50580-378-06 Tylenol Extra Strength 1 in 1 CARTON TABLET, FILM COATED 1 16 50580-378-07 Tylenol Extra Strength 1 in 1 CARTON TABLET, FILM COATED 1 16 50580-378-07 Tylenol Extra Strength 225 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 225 16 50580-378-08 Tylenol Extra Strength 325 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 325 16 50580-378-37 Tylenol Extra Strength 320 in 1 BOTTLE TABLET, FILM COATED 320 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Acetaminophen ACTIVE INGREDIENT 362O9ITL9D TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 1 Acetaminophen ACTIVE MOIETY 362O9ITL9D TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 1 aluminum oxide INACTIVE INGREDIENT LMI26O6933 TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 1 carnauba wax INACTIVE INGREDIENT R12CBM0EIZ TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 1 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 1 crospovidone INACTIVE INGREDIENT 68401960MK TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 1 FD&C red no. 40 INACTIVE INGREDIENT WZB9127XOA TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 1 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 1 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 1 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 1 povidones INACTIVE INGREDIENT FZ989GH94E TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 1 shellac INACTIVE INGREDIENT 46N107B71O TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 1 sodium starch glycolate type A potato INACTIVE INGREDIENT 5856J3G2A2 TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 1 stearic acid INACTIVE INGREDIENT 4ELV7Z65AP TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-378 TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [KENVUE BRANDS LLC] 14 Current NDC, Legacy NDC, 15 package rows 20250221_17cfa99d-abb2-4d77-9e0e-e77109fbb61a.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 13 of 79 · 1,579 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50580-378-01 50580037801 1 BOTTLE, PLASTIC in 1 CARTON (50580-378-01) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2014-11-01 0000-00-00 No No Current 50580-378-02 50580037802 1 BOTTLE, PLASTIC in 1 CARTON (50580-378-02) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2014-11-01 0000-00-00 No No Current 50580-378-03 50580037803 225 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50580-378-03) 2015-04-06 0000-00-00 No No Current 50580-378-04 50580037804 1 BOTTLE, PLASTIC in 1 CARTON (50580-378-04) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2021-03-01 0000-00-00 No No Current 50580-378-05 50580037805 1 BOTTLE, PLASTIC in 1 CARTON (50580-378-05) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2021-03-01 0000-00-00 No No Current 50580-378-06 50580037806 1 BOTTLE, PLASTIC in 1 CARTON (50580-378-06) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2021-03-01 0000-00-00 No No Current 50580-378-07 50580037807 1 BOTTLE, PLASTIC in 1 CARTON (50580-378-07) / 225 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2021-03-01 0000-00-00 No No Current 50580-378-08 50580037808 325 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50580-378-08) 2021-03-01 0000-00-00 No No Current 50580-378-37 50580037837 320 TABLET, FILM COATED in 1 BOTTLE (50580-378-37) 2026-03-31 No No Current