Home NDC 50580-451 TYLENOL
Product NDC 50580-451
11-digit product format 505800451
Labeler code 50580
Product ID 50580-451_2d87c8e1-e743-56cc-e063-6394a90aac79
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET, COATED
Route ORAL
Labeler Kenvue Brands LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 1994-08-19
Substance ACETAMINOPHEN
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
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
Brand name suffix 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.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50580-451-03 TYLENOLExtra Strength 1 in 1 POUCH TABLET, COATED 1 16 50580-451-03 TYLENOLExtra Strength 150 in 1 CARTON TABLET, COATED 150 16 50580-451-10 TYLENOLExtra Strength 10 in 1 CARTON TABLET, COATED 10 16 50580-451-10 TYLENOLExtra Strength 10 in 1 BLISTER PACK TABLET, COATED 10 16 50580-451-50 TYLENOLExtra Strength 1 in 1 CARTON TABLET, COATED 1 16 50580-451-50 TYLENOLExtra Strength 50 in 1 BOTTLE, PLASTIC TABLET, COATED 50 16 50580-451-70 TYLENOLExtra Strength 700 in 1 BOTTLE, PLASTIC TABLET, COATED 700 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, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 5 Acetaminophen ACTIVE MOIETY 362O9ITL9D TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 5 aluminum oxide INACTIVE INGREDIENT LMI26O6933 TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 5 Carnauba wax INACTIVE INGREDIENT R12CBM0EIZ TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 5 castor oil INACTIVE INGREDIENT D5340Y2I9G TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 5 FD&C red No. 40 INACTIVE INGREDIENT WZB9127XOA TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 5 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 5 magnesium stearate INACTIVE INGREDIENT 70097M6I30 TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 5 Polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 5 powdered cellulose INACTIVE INGREDIENT SMD1X3XO9M TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 5 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 5 shellac INACTIVE INGREDIENT 46N107B71O TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 5 Sodium Starch Glycolate Type A Potato INACTIVE INGREDIENT 5856J3G2A2 TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 5 starch, corn INACTIVE INGREDIENT O8232NY3SJ TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 5 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-451 TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [KENVUE BRANDS LLC] 16 Current NDC, Legacy NDC, 7 package rows 20250221_bb6533e5-e6a9-488c-b8ab-a6a06e87ede9.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 6 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join childrens fever reducer and pain reliever ACETAMINOPHEN Rite Aid Corporation a63727c3-64d8-4ae9-8da3-974cae6beed2 2026-07-24 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Aurohealth LLC e4a2566e-48ec-4602-87e3-143398d15f33 2026-07-24 Warnings Exact identifier application number: M013 infants fever reducer and pain reliever ACETAMINOPHEN Rite Aid Corporation 920e7055-7ed1-4db4-9215-f8933078bb7b 2026-07-24 Warnings Exact identifier application number: M013 Dye Free Pain and Fever Childrens ACETAMINOPHEN Walgreens c6665c11-9a01-4472-a444-acadb1de0b69 2026-07-23 Warnings Exact identifier application number: M013 Tylenol Extra Strength ACETAMINOPHEN Kenvue Brands LLC 103d109d-f520-409c-8da2-eb6b0fbec891 2026-07-22 Warnings Exact identifier application number: M013 Tylenol PM Extra Strength ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE Kenvue Brands LLC ce58105b-f010-47af-8f31-6dd4ce4e9cba 2026-07-22 Warnings Exact identifier application number: M013 GOOD SENSE INFANTS PAIN AND FEVER ACETAMINOPHEN L. Perrigo Company a7cc3964-e8fa-41da-89ca-b0d2aa80f2a7 2026-07-22 Warnings Exact identifier application number: M013 Childrens Acetaminophen ACETAMINOPHEN Cardinal Health 107, LLC 7562f4e4-54fa-488c-a199-48ad2632e2a1 2026-07-21 Warnings Exact identifier application number: M013 Medline ACETAMINOPHEN Medline Industries, LP 4b1d7243-b943-4e2b-e063-6294a90a2c4e 2026-07-20 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN LEADER/ Cardinal Health 110, Inc. 7c342ae6-5de6-5c2f-e053-2a91aa0a3f0d 2026-07-16 Warnings Exact identifier application number: M013 Rapidol 500 Extra Strength ACETAMINOPHEN Pharmadel LLC 1d9fa7ec-a509-28b2-e063-6294a90a7831 2026-07-16 Warnings Exact identifier application number: M013 equate pain relief ACETAMINOPHEN WALMART INC. 2f9b2550-5476-49ae-b741-54416a40bc29 2026-07-16 Warnings Exact identifier application number: M013 Pain Relief PM ACETAMINOPHEN, DIPHENHYDRAMINE HCL HyVee Inc 4f45a750-1220-4a81-801e-bf08c9d117d6 2026-07-16 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN Dr. Reddy's Laboratories Inc. 9d34abc2-3a9a-b68f-80d4-4ede1eb1e45f 2026-07-15 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Family Dollar, Inc. 3f182571-3212-eb29-e063-6294a90a9fa0 2026-07-15 Warnings Exact identifier application number: M013 Aspirin ASPIRIN DOLGENCORP, LLC 955484a6-2a7a-4b15-a9b4-e888ed5de04c 2026-07-15 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Geri-Care Pharmaceuticals, Corp 58941782-362d-4436-b365-e909bdbd29a2 2026-07-15 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN Major Pharmaceuticals 44730dfb-5062-4015-924b-c30b6c2b19c2 2026-07-13 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE Cardinal Health 110, LLC. DBA Leader f1cd0d59-12a8-4ff2-942a-6faa6907ef05 2026-07-13 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Amerisource Bergen 2c5e80e8-a979-45fb-9297-8ff294280c25 2026-07-13 Warnings Exact identifier application number: M013
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 50580-451-03 50580045103 1 in 1 POUCH Historical 50580-451-10 50580045110 10 in 1 CARTON Historical 50580-451-50 50580045150 1 BOTTLE, PLASTIC in 1 CARTON (50580-451-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC 1994-08-19 0000-00-00 No No Current 50580-451-70 50580045170 700 TABLET, COATED in 1 BOTTLE, PLASTIC (50580-451-70) 1994-08-19 0000-00-00 No No Current