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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50580-78350580-783-29DDiscontinued by firm2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019872-001TYLENOLACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORALRLD, RS1994-06-08
N019872-002TYLENOLACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORALRLD, RS2001-01-11

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tylenol 8 HR Arthritis PainACETAMINOPHENKenvue Brands LLC3af22fc8-e4e0-4863-8696-6bc1257047cb2024-11-13WarningsExact identifier

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
IngredientStrength
ACETAMINOPHEN650 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui1148399, 1243440

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
377068df-225f-7318-a910-a1987cdfa361Product name320170608
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-783-10Tylenol 8 HR Arthritis Pain100 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE10016
50580-783-10Tylenol 8 HR Arthritis Pain1 in 1 CARTONTABLET, EXTENDED RELEASE116
50580-783-24Tylenol 8 HR Arthritis Pain1 in 1 CARTONTABLET, EXTENDED RELEASE116
50580-783-24Tylenol 8 HR Arthritis Pain24 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE2416
50580-783-25Tylenol 8 HR Arthritis Pain1 in 1 CARTONTABLET, EXTENDED RELEASE116
50580-783-25Tylenol 8 HR Arthritis Pain225 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE22516
50580-783-29Tylenol 8 HR Arthritis Pain290 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE29016
50580-783-29Tylenol 8 HR Arthritis Pain1 in 1 CARTONTABLET, EXTENDED RELEASE116
50580-783-30Tylenol 8 HR Arthritis Pain290 in 1 BOTTLETABLET, EXTENDED RELEASE29016
50580-783-31Tylenol 8 HR Arthritis Pain50 in 1 BOTTLETABLET, EXTENDED RELEASE5016
50580-783-31Tylenol 8 HR Arthritis Pain1 in 1 CARTONTABLET, EXTENDED RELEASE116
50580-783-32Tylenol 8 HR Arthritis Pain1 in 1 CARTONTABLET, EXTENDED RELEASE116
50580-783-32Tylenol 8 HR Arthritis Pain100 in 1 BOTTLETABLET, EXTENDED RELEASE10016
50580-783-51Tylenol 8 HR Arthritis Pain2 in 1 POUCHTABLET, EXTENDED RELEASE216
50580-783-51Tylenol 8 HR Arthritis Pain50 in 1 CARTONTABLET, EXTENDED RELEASE5016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-783-10EA - Each50580-783c041eb5a-b9a4-4192-86dd-d198b9693ec212017-04-05
50580-783-24EA - Each50580-7831652964d-fe0b-44f0-903d-4c6c38350d1112022-07-06
50580-783-25EA - Each50580-7839a54be68-ab11-44c4-b0e8-9c29e0770c3f12017-04-05
50580-783-30EA - Each50580-783c4c4a604-7575-48e5-87fc-5606ce30c89d12024-05-16
50580-783-31EA - Each50580-783e68cd84a-6983-4afb-b320-9fb90c72d39a12022-08-04
50580-783-32EA - Each50580-7831a2bb08a-9832-42da-83c7-d96bea0f79b912020-09-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DTYLENOL 8 HR ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [MCNEIL CONSUMER HEALTHCARE DIV OF MCNEIL PPC, INC.]1
AcetaminophenACTIVE MOIETY362O9ITL9DTYLENOL 8 HR ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [MCNEIL CONSUMER HEALTHCARE DIV OF MCNEIL PPC, INC.]1
carnauba waxINACTIVE INGREDIENTR12CBM0EIZTYLENOL 8 HR ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [MCNEIL CONSUMER HEALTHCARE DIV OF MCNEIL PPC, INC.]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UTYLENOL 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 INGREDIENT8136Y38GY5TYLENOL 8 HR ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [MCNEIL CONSUMER HEALTHCARE DIV OF MCNEIL PPC, INC.]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WOTYLENOL 8 HR ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [MCNEIL CONSUMER HEALTHCARE DIV OF MCNEIL PPC, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30TYLENOL 8 HR ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [MCNEIL CONSUMER HEALTHCARE DIV OF MCNEIL PPC, INC.]1
povidonesINACTIVE INGREDIENTFZ989GH94ETYLENOL 8 HR ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [MCNEIL CONSUMER HEALTHCARE DIV OF MCNEIL PPC, INC.]1
powdered celluloseINACTIVE INGREDIENTSMD1X3XO9MTYLENOL 8 HR ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [MCNEIL CONSUMER HEALTHCARE DIV OF MCNEIL PPC, INC.]1
sodium starch glycolate type a potatoINACTIVE INGREDIENT5856J3G2A2TYLENOL 8 HR ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [MCNEIL CONSUMER HEALTHCARE DIV OF MCNEIL PPC, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTYLENOL 8 HR ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [MCNEIL CONSUMER HEALTHCARE DIV OF MCNEIL PPC, INC.]1
triacetinINACTIVE INGREDIENTXHX3C3X673TYLENOL 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
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-783TYLENOL 8 HR ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [KENVUE BRANDS LLC]16Current NDC, Legacy NDC, 15 package rows20241116_3af22fc8-e4e0-4863-8696-6bc1257047cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSN3af22fc8-e4e0-4863-8696-6bc1257047cb16
1243440Tylenol 650 MG 8HR Extended Release Oral TabletPSN3af22fc8-e4e0-4863-8696-6bc1257047cb16
12434408 HR acetaminophen 650 MG Extended Release Oral Tablet [Tylenol]SBD3af22fc8-e4e0-4863-8696-6bc1257047cb16
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCD3af22fc8-e4e0-4863-8696-6bc1257047cb16
11483998 HR APAP 650 MG Extended Release Oral TabletSY3af22fc8-e4e0-4863-8696-6bc1257047cb16
12434408 HR APAP 650 MG Extended Release Oral Tablet [Tylenol]SY3af22fc8-e4e0-4863-8696-6bc1257047cb16
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSY3af22fc8-e4e0-4863-8696-6bc1257047cb16
1243440Tylenol 650 MG 8 HR Extended Release Oral TabletSY3af22fc8-e4e0-4863-8696-6bc1257047cb16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-783-10505800783101 BOTTLE, PLASTIC in 1 CARTON (50580-783-10) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC2015-07-130000-00-00NoNoCurrent
50580-783-24505800783241 BOTTLE, PLASTIC in 1 CARTON (50580-783-24) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC2015-07-130000-00-00NoNoCurrent
50580-783-25505800783251 BOTTLE, PLASTIC in 1 CARTON (50580-783-25) / 225 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC2015-07-130000-00-00NoNoCurrent
50580-783-2950580078329290 in 1 BOTTLE, PLASTICHistorical
50580-783-3050580078330290 TABLET, EXTENDED RELEASE in 1 BOTTLE (50580-783-30) 2018-02-120000-00-00NoNoCurrent
50580-783-31505800783311 BOTTLE in 1 CARTON (50580-783-31) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2022-06-010000-00-00NoNoCurrent
50580-783-32505800783321 BOTTLE in 1 CARTON (50580-783-32) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2019-08-260000-00-00NoNoCurrent
50580-783-515058007835150 POUCH in 1 CARTON (50580-783-51) / 2 TABLET, EXTENDED RELEASE in 1 POUCH50 pouch2024-11-22NoNoCurrent