Home NDC 50580-783 Tylenol 8 HR Arthritis Pain
Product NDC 50580-783
11-digit product format 505800783
Labeler code 50580
Product ID 50580-783_26c62e88-08c4-1113-e063-6394a90ac1f8
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler Kenvue Brands LLC
Application NDA019872
Marketing category NDA
Marketing start 2015-07-13
Substance ACETAMINOPHEN
Active strength 650 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes NDC auxiliary status# Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date excluded package package 50580-783 50580-783-29 D Discontinued by firm 2026-07-31
Orange Book products# Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019872-001 TYLENOL ACETAMINOPHEN 650MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 1994-06-08 N019872-002 TYLENOL ACETAMINOPHEN 650MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 2001-01-11
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 6 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Additional Listing Data#
Finished product Yes
Brand name base Tylenol 8 HR Arthritis Pain
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 650 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii 362O9ITL9D Rxcui 1148399, 1243440
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50580-783-10 Tylenol 8 HR Arthritis Pain 100 in 1 BOTTLE, PLASTIC TABLET, EXTENDED RELEASE 100 16 50580-783-10 Tylenol 8 HR Arthritis Pain 1 in 1 CARTON TABLET, EXTENDED RELEASE 1 16 50580-783-24 Tylenol 8 HR Arthritis Pain 1 in 1 CARTON TABLET, EXTENDED RELEASE 1 16 50580-783-24 Tylenol 8 HR Arthritis Pain 24 in 1 BOTTLE, PLASTIC TABLET, EXTENDED RELEASE 24 16 50580-783-25 Tylenol 8 HR Arthritis Pain 1 in 1 CARTON TABLET, EXTENDED RELEASE 1 16 50580-783-25 Tylenol 8 HR Arthritis Pain 225 in 1 BOTTLE, PLASTIC TABLET, EXTENDED RELEASE 225 16 50580-783-29 Tylenol 8 HR Arthritis Pain 290 in 1 BOTTLE, PLASTIC TABLET, EXTENDED RELEASE 290 16 50580-783-29 Tylenol 8 HR Arthritis Pain 1 in 1 CARTON TABLET, EXTENDED RELEASE 1 16 50580-783-30 Tylenol 8 HR Arthritis Pain 290 in 1 BOTTLE TABLET, EXTENDED RELEASE 290 16 50580-783-31 Tylenol 8 HR Arthritis Pain 50 in 1 BOTTLE TABLET, EXTENDED RELEASE 50 16 50580-783-31 Tylenol 8 HR Arthritis Pain 1 in 1 CARTON TABLET, EXTENDED RELEASE 1 16 50580-783-32 Tylenol 8 HR Arthritis Pain 1 in 1 CARTON TABLET, EXTENDED RELEASE 1 16 50580-783-32 Tylenol 8 HR Arthritis Pain 100 in 1 BOTTLE TABLET, EXTENDED RELEASE 100 16 50580-783-51 Tylenol 8 HR Arthritis Pain 2 in 1 POUCH TABLET, EXTENDED RELEASE 2 16 50580-783-51 Tylenol 8 HR Arthritis Pain 50 in 1 CARTON TABLET, EXTENDED RELEASE 50 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Acetaminophen ACTIVE INGREDIENT 362O9ITL9D TYLENOL 8 HR ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [MCNEIL CONSUMER HEALTHCARE DIV OF MCNEIL PPC, INC.] 1 Acetaminophen ACTIVE MOIETY 362O9ITL9D TYLENOL 8 HR ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [MCNEIL CONSUMER HEALTHCARE DIV OF MCNEIL PPC, INC.] 1 carnauba wax INACTIVE INGREDIENT R12CBM0EIZ TYLENOL 8 HR ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [MCNEIL CONSUMER HEALTHCARE DIV OF MCNEIL PPC, INC.] 1 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U TYLENOL 8 HR ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [MCNEIL CONSUMER HEALTHCARE DIV OF MCNEIL PPC, INC.] 1 hydroxyethyl cellulose (140 mpa.s at 5%) INACTIVE INGREDIENT 8136Y38GY5 TYLENOL 8 HR ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [MCNEIL CONSUMER HEALTHCARE DIV OF MCNEIL PPC, INC.] 1 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO TYLENOL 8 HR ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [MCNEIL CONSUMER HEALTHCARE DIV OF MCNEIL PPC, INC.] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 TYLENOL 8 HR ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [MCNEIL CONSUMER HEALTHCARE DIV OF MCNEIL PPC, INC.] 1 povidones INACTIVE INGREDIENT FZ989GH94E TYLENOL 8 HR ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [MCNEIL CONSUMER HEALTHCARE DIV OF MCNEIL PPC, INC.] 1 powdered cellulose INACTIVE INGREDIENT SMD1X3XO9M TYLENOL 8 HR ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [MCNEIL CONSUMER HEALTHCARE DIV OF MCNEIL PPC, INC.] 1 sodium starch glycolate type a potato INACTIVE INGREDIENT 5856J3G2A2 TYLENOL 8 HR ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [MCNEIL CONSUMER HEALTHCARE DIV OF MCNEIL PPC, INC.] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP TYLENOL 8 HR ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [MCNEIL CONSUMER HEALTHCARE DIV OF MCNEIL PPC, INC.] 1 triacetin INACTIVE INGREDIENT XHX3C3X673 TYLENOL 8 HR ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [MCNEIL CONSUMER HEALTHCARE DIV OF MCNEIL PPC, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-783 TYLENOL 8 HR ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [KENVUE BRANDS LLC] 16 Current NDC, Legacy NDC, 15 package rows 20241116_3af22fc8-e4e0-4863-8696-6bc1257047cb.zip
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 50580-783-10 50580078310 1 BOTTLE, PLASTIC in 1 CARTON (50580-783-10) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC 2015-07-13 0000-00-00 No No Current 50580-783-24 50580078324 1 BOTTLE, PLASTIC in 1 CARTON (50580-783-24) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC 2015-07-13 0000-00-00 No No Current 50580-783-25 50580078325 1 BOTTLE, PLASTIC in 1 CARTON (50580-783-25) / 225 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC 2015-07-13 0000-00-00 No No Current 50580-783-29 50580078329 290 in 1 BOTTLE, PLASTIC Historical 50580-783-30 50580078330 290 TABLET, EXTENDED RELEASE in 1 BOTTLE (50580-783-30) 2018-02-12 0000-00-00 No No Current 50580-783-31 50580078331 1 BOTTLE in 1 CARTON (50580-783-31) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE 1 bottle 2022-06-01 0000-00-00 No No Current 50580-783-32 50580078332 1 BOTTLE in 1 CARTON (50580-783-32) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE 1 bottle 2019-08-26 0000-00-00 No No Current 50580-783-51 50580078351 50 POUCH in 1 CARTON (50580-783-51) / 2 TABLET, EXTENDED RELEASE in 1 POUCH 50 pouch 2024-11-22 No No Current