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 5 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SurviveX Travel Med MOD CONVENIENCE KIT Intent Brands LLC 522da86b-cfd7-dd20-e063-6394a90a51c6 2026-08-04 Warnings Exact identifier application number: M013 Extra Strength Pain Reliever mini softgels ACETAMINOPHEN 500 MG Shield Pharmaceuticals Corp 0ebb1902-6f8a-4bfb-9f2e-839d43bfca37 2026-08-04 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN Better Living Brands, LLC 743af02c-c762-42f5-8e01-2f62da15e04e 2026-08-04 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Aurohealth LLC 9aea8aae-8702-4c93-8b07-69cd252f44d6 2026-08-03 Warnings Exact identifier application number: M013 Pain Relief Acetaminophen 325 mg ACETAMINOPHEN NUVICARE LLC 49a59b79-b8b4-4bf5-a403-0a14751efc55 2026-08-03 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Aurohealth LLC d4e98f8e-f24c-4bdd-b750-fa4f877fb621 2026-07-31 Warnings Exact identifier application number: M013 KinderFarms Childrens Pain and Fever ACETAMINOPHEN KinderFarms, LLC 4f86419a-b940-a9c6-e063-6394a90a6a2b 2026-07-30 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN Family Dollar Stores, LLC 53f7a9c8-f40e-19b2-e063-6394a90a8695 2026-07-29 Warnings Exact identifier application number: M013 KinderFarms Infants Pain and Fever ACETAMINOPHEN KinderFarms, LLC 5468b149-8fac-8d6a-e063-6294a90a8c51 2026-07-29 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN CVS PHARMACY 258975d2-d8e8-407d-9804-df3b37a184e4 2026-07-29 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 3ba0a9f2-062a-401e-82eb-54383a822366 2026-07-29 Warnings Exact identifier application number: M013 Aspirin 81mg Enteric Coated ASPIRIN Cardinal Health 107, LLC 277723db-3578-4842-92eb-2de325f87649 2026-07-28 Warnings Exact identifier application number: M013 Aspirin Low Dose Chewable ASPIRIN Better Living Brands, LLC 7afce7b4-c86a-43f7-83cf-15ebffba2f35 2026-07-28 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Aurohealth LLC f818996c-36d2-4d3d-af3e-39949157edb9 2026-07-28 Warnings Exact identifier application number: M013 Pain Reliever PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL L.N.K. International, Inc. 03b871e8-3e14-4ed8-a978-45129255b272 2026-07-27 Warnings Exact identifier application number: M013 Pain Relief Acetaminophen PM Extra Strength ACETAMINOPHEN AND DIPHENHYDRAMINE HCL Rite Aid Corporation 17d27771-a112-474f-9a58-29af0d7e1af3 2026-07-27 Warnings Exact identifier application number: M013 Infants TYLENOL ACETAMINOPHEN Kenvue Brands LLC 2143cc16-86db-4060-96da-5c228ae9207b 2026-07-24 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Softgel Healthcare Pvt Ltd 352bb451-ffdc-411a-e063-6294a90a8cf5 2026-07-24 Warnings Exact identifier application number: M013 acetaminophen ACETAMINOPHEN NuCare Pharmaceuticals,Inc. fdb7331a-d029-8b2a-e053-6294a90adfcd 2026-07-24 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Aurohealth LLC 5ada044e-50e8-4874-ac04-df5f1f9e735d 2026-07-24 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