Home NDC 50580-937 Tylenol Extra Strength
Product NDC 50580-937
11-digit product format 505800937
Labeler code 50580
Product ID 50580-937_572fcd5f-40f6-eaf1-e063-6294a90a4143
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 2019-08-19
Substance ACETAMINOPHEN
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
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 · 48 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 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 50580-937-01 Tylenol Extra Strength 10 in 1 VIAL TABLET, FILM COATED 10 15 50580-937-01 Tylenol Extra Strength 12 in 1 PACKAGE TABLET, FILM COATED 12 15 50580-937-02 Tylenol Extra Strength 10 in 1 VIAL TABLET, FILM COATED 10 15 50580-937-02 Tylenol Extra Strength 12 in 1 PACKAGE TABLET, FILM COATED 12 15 50580-937-03 Tylenol Extra Strength 2 in 1 POUCH TABLET, FILM COATED 2 15 50580-937-04 Tylenol Extra Strength 2 in 1 POUCH TABLET, FILM COATED 2 15 50580-937-04 Tylenol Extra Strength 3 in 1 CARTON TABLET, FILM COATED 3 15 50580-937-05 Tylenol Extra Strength 2 in 1 POUCH TABLET, FILM COATED 2 15 50580-937-05 Tylenol Extra Strength 50 in 1 CARTON TABLET, FILM COATED 50 15 50580-937-06 Tylenol Extra Strength 1 in 1 CARTON TABLET, FILM COATED 1 15 50580-937-06 Tylenol Extra Strength 24 in 1 BOTTLE TABLET, FILM COATED 24 15 50580-937-07 Tylenol Extra Strength 100 in 1 BOTTLE TABLET, FILM COATED 100 15 50580-937-07 Tylenol Extra Strength 1 in 1 CARTON TABLET, FILM COATED 1 15 50580-937-10 Tylenol Extra Strength 1 in 1 CARTON TABLET, FILM COATED 1 15 50580-937-10 Tylenol Extra Strength 50 in 1 BOTTLE TABLET, FILM COATED 50 15 50580-937-15 Tylenol Extra Strength 1 in 1 CARTON TABLET, FILM COATED 1 15 50580-937-15 Tylenol Extra Strength 225 in 1 BOTTLE TABLET, FILM COATED 225 15 50580-937-19 Tylenol Extra Strength 325 in 1 BOTTLE TABLET, FILM COATED 325 15 50580-937-20 Tylenol Extra Strength 2 in 1 POUCH TABLET, FILM COATED 2 15 50580-937-20 Tylenol Extra Strength 50 in 1 CARTON TABLET, FILM COATED 50 15 50580-937-23 Tylenol Extra Strength 2 in 1 POUCH TABLET, FILM COATED 2 15 50580-937-23 Tylenol Extra Strength 3 in 1 CARTON TABLET, FILM COATED 3 15 50580-937-25 Tylenol Extra Strength 2500 in 1 CASE TABLET, FILM COATED 2500 15 50580-937-25 Tylenol Extra Strength 2 in 1 POUCH TABLET, FILM COATED 2 15 50580-937-37 Tylenol Extra Strength 320 in 1 BOTTLE TABLET, FILM COATED 320 15 50580-937-50 Tylenol Extra Strength 2 in 1 POUCH TABLET, FILM COATED 2 15 50580-937-50 Tylenol Extra Strength 50 in 1 CARTON TABLET, FILM COATED 50 15 50580-937-51 Tylenol Extra Strength 2 in 1 POUCH TABLET, FILM COATED 2 15 50580-937-51 Tylenol Extra Strength 50 in 1 CARTON TABLET, FILM COATED 50 15 50580-937-66 Tylenol Extra Strength 2 in 1 CARTON TABLET, FILM COATED 2 15 50580-937-66 Tylenol Extra Strength 100 in 1 BOTTLE TABLET, FILM COATED 100 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-937 TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [KENVUE BRANDS LLC] 13 Current NDC, Legacy NDC, 31 package rows 20250221_103d109d-f520-409c-8da2-eb6b0fbec891.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 75 of 79 · 1,576 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Alka-Seltzer BUFFERED ASPIRIN Lil' Drug Store Products, Inc. 0c7a60e7-0bde-9aa2-e063-6294a90a3209 2023-12-14 Warnings Exact identifier application number: M013 Circle K Aspirin 325 ASPIRIN Lil Drug Store Products, Inc 4cd306e3-2119-4272-9da4-a848fe2746fa 2023-12-14 Warnings Exact identifier application number: M013 Circle K Pain Reliever Extra Strength ACETAMINOPHEN Lil' Drug Store Products, Inc. f2359bc3-901f-4ecb-b402-cb2fe404a935 2023-12-14 Warnings Exact identifier application number: M013 Childrens Pain Relief ACETAMINOPHEN DISCOUNT DRUG MART c55b8f9d-1396-43c0-acc9-5e3485eadb07 2023-12-08 Warnings Exact identifier application number: M013 Childrens Pain Relief ACETAMINOPHEN DISCOUNT DRUG MART 775519ad-5683-451f-9bfc-5fafc70c68ec 2023-12-08 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN WALGREEN CO. c20c814b-35f5-4c46-e053-2a95a90a50f2 2023-12-08 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN Better Living Brands LLC f9859be4-6d0b-2ab8-e053-6294a90aa862 2023-12-06 Warnings Exact identifier application number: M013 Aurophen Regular Strength ACETAMINOPHEN KROGER COMPANY b9b7b849-c3b3-9af7-e053-2a95a90a0077 2023-12-06 Warnings Exact identifier application number: M013 Acetaminophen Regular Strength ACETAMINOPHEN KROGER COMPANY cf649478-57d2-cc88-e053-2a95a90ad1ba 2023-12-06 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN KROGER COMPANY b9b6f878-1ec8-3dc0-e053-2995a90a5414 2023-12-06 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN WALGREEN CO. a48c522c-76c5-49f8-8c4d-3ee6b221e6f3 2023-12-06 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN WALGREEN CO. cc939a7c-ce56-5dd6-e053-2995a90aa8af 2023-12-06 Warnings Exact identifier application number: M013 Alka-Seltzer Original Flavor BUFFERED ASPIRIN, EFFERVESCENT TABLET Lil' Drug Store Products, Inc. ea5df8be-a08c-5fa3-e053-2995a90a0bac 2023-12-06 Warnings Exact identifier application number: M013 Ringl ACETAMINOPHEN Sato Pharmaceutical Co., Ltd. ba5a0286-3e0f-4bef-96e5-29d92f51f432 2023-12-06 Warnings Exact identifier application number: M013 Pain Relief Childrens ACETAMINOPHEN Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 41633554-474e-4d3c-9187-d90487d2ae8c 2023-12-06 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN Family Dollar Stores, LLC f86dcbb8-debc-4bce-e053-6294a90a7a02 2023-12-05 Warnings Exact identifier application number: M013 Sanatos Multi Symptom Daytime ACETAMINOPHEN, DEXTROMETHORPHAN HBR Pharmadel LLC 0a5fc0ef-ba34-bb0b-e063-6394a90af7d9 2023-12-01 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Proficient Rx LP 402c8563-b14b-453f-80bc-4275f1c73702 2023-12-01 Warnings Exact identifier application number: M013 Acetaminophen and Diphenhydramine hydrochloride ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE Aurohealth LLC 3ba51b52-7ae6-4335-b178-1b7b6ef36227 2023-11-29 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN Aurohealth LLC bc03fa56-8880-4bbd-81a0-91853fecdd4e 2023-11-29 Warnings Exact identifier application number: M013
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 50580-937-01 50580093701 12 VIAL in 1 PACKAGE (50580-937-01) / 10 TABLET, FILM COATED in 1 VIAL 12 vial 2019-08-19 0000-00-00 No No Current 50580-937-02 50580093702 12 VIAL in 1 PACKAGE (50580-937-02) / 10 TABLET, FILM COATED in 1 VIAL 12 vial 2019-09-16 0000-00-00 No No Current 50580-937-03 50580093703 2 TABLET, FILM COATED in 1 POUCH (50580-937-03) 2020-07-31 0000-00-00 No No Current 50580-937-04 50580093704 3 POUCH in 1 CARTON (50580-937-04) > 2 TABLET, FILM COATED in 1 POUCH 3 pouch 2020-07-31 0000-00-00 No No Current 50580-937-05 50580093705 50 POUCH in 1 CARTON (50580-937-05) > 2 TABLET, FILM COATED in 1 POUCH 50 pouch 2020-07-31 0000-00-00 No No Current 50580-937-06 50580093706 1 BOTTLE in 1 CARTON (50580-937-06) / 24 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2020-08-31 0000-00-00 No No Current 50580-937-07 50580093707 1 BOTTLE in 1 CARTON (50580-937-07) / 100 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2020-08-31 0000-00-00 No No Current 50580-937-10 50580093710 1 BOTTLE in 1 CARTON (50580-937-10) / 50 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2020-08-31 0000-00-00 No No Current 50580-937-15 50580093715 1 BOTTLE in 1 CARTON (50580-937-15) / 225 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2020-08-31 0000-00-00 No No Current 50580-937-19 50580093719 325 TABLET, FILM COATED in 1 BOTTLE (50580-937-19) 2020-08-31 0000-00-00 No No Current 50580-937-20 50580093720 50 POUCH in 1 CARTON (50580-937-20) > 2 TABLET, FILM COATED in 1 POUCH 50 pouch 2020-07-31 0000-00-00 No No Current 50580-937-23 50580093723 3 POUCH in 1 CARTON (50580-937-23) / 2 TABLET, FILM COATED in 1 POUCH 3 pouch 2026-01-15 No No Current 50580-937-25 50580093725 2500 POUCH in 1 CASE (50580-937-25) / 2 TABLET, FILM COATED in 1 POUCH 2500 pouch 2025-12-28 No No Current 50580-937-37 50580093737 320 TABLET, FILM COATED in 1 BOTTLE (50580-937-37) 2026-03-31 No No Current 50580-937-50 50580093750 50 POUCH in 1 CARTON (50580-937-50) / 2 TABLET, FILM COATED in 1 POUCH 50 pouch 2025-12-28 No No Current 50580-937-51 50580093751 50 POUCH in 1 CARTON (50580-937-51) / 2 TABLET, FILM COATED in 1 POUCH 50 pouch 2025-12-28 No No Current 50580-937-66 50580093766 2 BOTTLE in 1 CARTON (50580-937-66) / 100 TABLET, FILM COATED in 1 BOTTLE 2 bottle 2024-05-01 No No Current