FDA.reportPublic FDA data

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

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