8 HR acetaminophen 650 MG Extended Release Oral Tablet [Tylenol]

RxCUI
1243440
RxNorm name
8 HR acetaminophen 650 MG Extended Release Oral Tablet [Tylenol]
Display name
TYLENOL XR (Oral Pill)
Full name
8 HR acetaminophen 650 MG Extended Release Oral Tablet [Tylenol]
Term type
SBD
Status
Active
Strength
650 mg
Dose form
8 HR XR Tab
Route
Oral Pill
Updated
2026-10-17 23:46:20

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
032012
Active start
032012
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
acetaminophen650 MG / 1 EACHacetaminophenacetaminophen

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Extended Release Oral Tablet316945

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
acetaminophen161

Source Vocabulary Codes#

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
50580-309-0150580-309Tylenol 8HR acetaminophenKenvue Brands LLCNDA019872
50580-309-0250580-309Tylenol 8HR acetaminophenKenvue Brands LLCNDA019872
50580-575-0150580-575TYLENOL 8 HR ARTHRITIS PAIN AcetaminophenKenvue Brands LLCANDA211544
50580-575-0250580-575TYLENOL 8 HR ARTHRITIS PAIN AcetaminophenKenvue Brands LLCANDA211544
50580-575-0350580-575TYLENOL 8 HR ARTHRITIS PAIN AcetaminophenKenvue Brands LLCANDA211544
50580-575-0650580-575TYLENOL 8 HR ARTHRITIS PAIN AcetaminophenKenvue Brands LLCANDA211544
50580-576-0150580-576TYLENOL 8 HR MUSCLE ACHES AND PAIN acetaminophenKenvue Brands LLCANDA211544
50580-576-0250580-576TYLENOL 8 HR MUSCLE ACHES AND PAIN acetaminophenKenvue Brands LLCANDA211544
50580-783-1050580-783Tylenol 8 HR Arthritis Pain AcetaminophenKenvue Brands LLCNDA019872
50580-783-2450580-783Tylenol 8 HR Arthritis Pain AcetaminophenKenvue Brands LLCNDA019872
50580-783-2550580-783Tylenol 8 HR Arthritis Pain AcetaminophenKenvue Brands LLCNDA019872
50580-783-3050580-783Tylenol 8 HR Arthritis Pain AcetaminophenKenvue Brands LLCNDA019872
50580-783-3150580-783Tylenol 8 HR Arthritis Pain AcetaminophenKenvue Brands LLCNDA019872
50580-783-3250580-783Tylenol 8 HR Arthritis Pain AcetaminophenKenvue Brands LLCNDA019872
50580-783-5150580-783Tylenol 8 HR Arthritis Pain AcetaminophenKenvue Brands LLCNDA019872

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA01987250580-309Tylenol 8HR acetaminophenNDAKenvue Brands LLC
ANDA21154450580-575TYLENOL 8 HR ARTHRITIS PAIN AcetaminophenANDAKenvue Brands LLC

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 64 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00045029721rxnav_ndcsyes
00045029727rxnav_ndcsyes
00045083824rxnav_ndcsyes
50580030901rxnav_ndcsyes
50580030902rxnav_ndcsyes
50580057501rxnav_ndcsyes
50580057502rxnav_ndcsyes
50580057503rxnav_ndcsyes
50580057506rxnav_ndcsyes
50580057601rxnav_ndcsyes
50580057602rxnav_ndcsyes
50580078310rxnav_ndcsyes
50580078324rxnav_ndcsyes
50580078325rxnav_ndcsyes
50580078329rxnav_ndcsyes
50580078330rxnav_ndcsyes
50580078331rxnav_ndcsyes
50580078332rxnav_ndcsyes
50580078351rxnav_ndcsyes
00045029711rxnav_historical
00045029718rxnav_historical
00045029720rxnav_historical
00045029726rxnav_historical
00045029734rxnav_historical
00045029751rxnav_historical
00045083806rxnav_historical
00045083815rxnav_historical
00045083821rxnav_historical
00045083825rxnav_historical
00045083829rxnav_historical
00045083837rxnav_historical
00045083850rxnav_historical
50580011202rxnav_historical
50580011206rxnav_historical
50580011210rxnav_historical
50580011212rxnav_historical
50580011215rxnav_historical
50580011221rxnav_historical
50580011222rxnav_historical
50580011224rxnav_historical
50580011225rxnav_historical
50580011226rxnav_historical
50580011229rxnav_historical
50580011237rxnav_historical
50580011250rxnav_historical
50580011259rxnav_historical
50580029220rxnav_historical
50580029240rxnav_historical
50580029280rxnav_historical
50580029705rxnav_historical
50580029710rxnav_historical
50580029715rxnav_historical
50580029720rxnav_historical
50580029724rxnav_historical
50580029734rxnav_historical
50580029750rxnav_historical
50580050520rxnav_historical
50580050540rxnav_historical
50580050545rxnav_historical
50580050580rxnav_historical
50580050588rxnav_historical
50580050820rxnav_historical
50580050840rxnav_historical
50580050880rxnav_historical

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tylenol 8 HR Arthritis PainACETAMINOPHENKenvue Brands LLC3af22fc8-e4e0-4863-8696-6bc1257047cb2024-11-13WarningsExact identifier
ndc (package): 50580-783-30
ndc (package): 50580-783-32
ndc (package): 50580-783-25
ndc (package): 50580-783-24
ndc (package): 50580-783-10
ndc (package): 50580-783-51
ndc (package): 50580-783-31
ndc (product): 50580-783
ndc11 (package): 50580078351
ndc11 (package): 50580078310
ndc11 (package): 50580078324
ndc11 (package): 50580078325
ndc11 (package): 50580078329
ndc11 (package): 50580078330
ndc11 (package): 50580078332
ndc11 (package): 50580078331
rxcui: 1243440
TYLENOL 8 HR MUSCLE ACHES AND PAINACETAMINOPHENKenvue Brands LLC037ec598-cba6-dbb6-e063-6394a90ac42c2024-11-07WarningsExact identifier
ndc (package): 50580-576-02
ndc (package): 50580-576-01
ndc (product): 50580-576
ndc11 (package): 50580057601
ndc11 (package): 50580057602
rxcui: 1243440
Tylenol 8HRACETAMINOPHENKenvue Brands LLC5d7d1300-bcb8-466a-880b-310b360ee1322024-11-07WarningsExact identifier
ndc (package): 50580-309-01
ndc (package): 50580-309-02
ndc (product): 50580-309
ndc11 (package): 50580030901
ndc11 (package): 50580030902
rxcui: 1243440
TYLENOL 8 HR ARTHRITIS PAINACETAMINOPHENKenvue Brands LLC0391963c-022d-1433-e063-6294a90aac902024-09-09WarningsExact identifier
ndc (package): 50580-575-03
ndc (package): 50580-575-01
ndc (package): 50580-575-06
ndc (package): 50580-575-02
ndc (product): 50580-575
ndc11 (package): 50580057503
ndc11 (package): 50580057502
ndc11 (package): 50580057501
ndc11 (package): 50580057506
rxcui: 1243440

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 4 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
3af22fc8-e4e0-4863-8696-6bc1257047cbTylenol 650 MG 8HR Extended Release Oral Tablet [PSN] · 8 HR acetaminophen 650 MG Extended Release Oral Tablet [Tylenol] [SBD] · 8 HR APAP 650 MG Extended Release Oral Tablet [Tylenol] [SY] · Tylenol 650 MG 8 HR Extended Release Oral Tablet [SY]416Tylenol ® 8 HR Arthritis Pain20241113
5d7d1300-bcb8-466a-880b-310b360ee132Tylenol 650 MG 8HR Extended Release Oral Tablet [PSN] · 8 HR acetaminophen 650 MG Extended Release Oral Tablet [Tylenol] [SBD] · 8 HR APAP 650 MG Extended Release Oral Tablet [Tylenol] [SY] · Tylenol 650 MG 8 HR Extended Release Oral Tablet [SY]49Tylenol ® 8HR20241107
037ec598-cba6-dbb6-e063-6394a90ac42cTylenol 650 MG 8HR Extended Release Oral Tablet [PSN] · 8 HR acetaminophen 650 MG Extended Release Oral Tablet [Tylenol] [SBD] · 8 HR APAP 650 MG Extended Release Oral Tablet [Tylenol] [SY] · Tylenol 650 MG 8 HR Extended Release Oral Tablet [SY]43Tylenol ® 8HR Muscle Aches & Pain20241107
0391963c-022d-1433-e063-6294a90aac90Tylenol 650 MG 8HR Extended Release Oral Tablet [PSN] · 8 HR acetaminophen 650 MG Extended Release Oral Tablet [Tylenol] [SBD] · 8 HR APAP 650 MG Extended Release Oral Tablet [Tylenol] [SY] · Tylenol 650 MG 8 HR Extended Release Oral Tablet [SY]43Tylenol 8 HR Arthritis Pain20240909

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
3af22fc8-e4e0-4863-8696-6bc1257047cbTylenol ® 8 HR Arthritis PainKenvue Brands LLC20241113
5d7d1300-bcb8-466a-880b-310b360ee132Tylenol ® 8HRKenvue Brands LLC20241107
037ec598-cba6-dbb6-e063-6394a90ac42cTylenol ® 8HR Muscle Aches & PainKenvue Brands LLC20241107
0391963c-022d-1433-e063-6294a90aac90Tylenol 8 HR Arthritis PainKenvue Brands LLC20240909
69b894b7-38e3-4645-a430-3e4dbe30f76fNational Council for Prescription Drug Programs20130213
d70ffa5f-be6f-42f2-a60b-9aafd046978dNational Council for Prescription Drug Programs20130213
15e1b6e1-d63d-46dc-85fd-9b126e72e0bdNational Council for Prescription Drug Programs20120724
25bc0b1b-cc4e-4169-bd32-2c20bc59bb99National Council for Prescription Drug Programs20120724
35ef1547-386b-482e-a106-0faf6a893c75National Council for Prescription Drug Programs20120724
4c574199-8895-492e-af53-5834c910523bNational Council for Prescription Drug Programs20120724
520c2eda-f801-4eef-996b-65c2444360d4National Council for Prescription Drug Programs20120724
be05dec4-c1af-433d-a3c3-faeff27794a2National Council for Prescription Drug Programs20120724
d09fea83-3580-4bd8-9c4e-e236bfca0637National Council for Prescription Drug Programs20120724
d36363ff-cfc6-4c09-b7b9-b3dccfcd519cNational Council for Prescription Drug Programs20120724
f7d727bc-1a24-4a19-b48e-35812164e275National Council for Prescription Drug Programs20120724

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCN02BEAnilidesATC1-4acetaminophen
MEDRTD000082AcetaminophenCHEMhas_ingredientacetaminophen
MEDRTD004342Drug HypersensitivityDISEASEci_withacetaminophen
MEDRTD005334FeverDISEASEmay_preventacetaminophen
MEDRTD005334FeverDISEASEmay_treatacetaminophen
MEDRTD005955Glucosephosphate Dehydrogenase DeficiencyDISEASEci_withacetaminophen
MEDRTD008107Liver DiseasesDISEASEci_withacetaminophen
MEDRTD010146PainDISEASEmay_preventacetaminophen
MEDRTD010146PainDISEASEmay_treatacetaminophen
MEDRTN0000000108Prostaglandin Receptor AntagonistsMOAhas_moaacetaminophen
MEDRTN0000175724Central Nervous System Activity AlterationPEhas_peacetaminophen
MEDRTN0000008836Decreased Prostaglandin ProductionPEhas_peacetaminophen
MEDRTN0000009072Hypothalamic Endocrine Activity AlterationPEhas_peacetaminophen
MEDRTN0000175725Peripheral Nervous System Activity AlterationPEhas_peacetaminophen
MEDRTN0000000026Hepatic MetabolismPKhas_pkacetaminophen
MEDRTN0000000042Renal ExcretionPKhas_pkacetaminophen

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH650 MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESQUANTITY8 HR
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESANDAANDA211544
CODESNDANDA019872
NAMESPrescribable SynonymTylenol 650 MG 8HR Extended Release Oral Tablet
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon