FDA.reportPublic FDA data

acetaminophen 500 MG / caffeine 65 MG Oral Tablet [Panadol Extra]

RxCUI
1872075
RxNorm name
acetaminophen 500 MG / caffeine 65 MG Oral Tablet [Panadol Extra]
Display name
PANADOL EXTRA (Oral Pill)
Full name
acetaminophen 500 MG / caffeine 65 MG Oral Tablet [Panadol Extra]
Term type
SBD
Status
Active
Strength
500-65 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-10-27 19:29:54

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
042017
Active start
042017
Multiple ingredient
YES
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
acetaminophen500 MG / 1 EACHacetaminophenacetaminophen
caffeine65 MG / 1 EACHcaffeinecaffeine

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Tablet317541

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
acetaminophen161
caffeine1886

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRAPAP 500 MG / Caffeine 65 MG Oral Tablet [Panadol Extra]1NAMES
RxNorm Nameacetaminophen 500 MG / caffeine 65 MG Oral Tablet [Panadol Extra]1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSBD1ATTRIBUTES
SPL_SET_IDe5c2d88a-d903-4ca0-b895-f27e791dfc4e1CODES
RxCUI18720751CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0135-0620-010135-0620PANADOL acetaminophen and caffeineHaleon US Holdings LLCM013

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M0130135-0620PANADOL acetaminophen and caffeineOTC MONOGRAPH DRUGHaleon US Holdings LLC

RxNav Current And Historical NDCs#

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

NDC11, Source, Active table
NDC11SourceActive
00135062001rxnav_ndcsyes

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PANADOL ExtraACETAMINOPHEN AND CAFFEINEHaleon US Holdings LLCe5c2d88a-d903-4ca0-b895-f27e791dfc4e2024-02-06WarningsExact identifier
ndc (package): 0135-0620-01
ndc (product): 0135-0620
ndc11 (package): 00135062001
rxcui: 1872075

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 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
e5c2d88a-d903-4ca0-b895-f27e791dfc4ePanadol Extra 500 MG / 65 MG Oral Tablet [PSN] · acetaminophen 500 MG / caffeine 65 MG Oral Tablet [Panadol Extra] [SBD] · APAP 500 MG / Caffeine 65 MG Oral Tablet [Panadol Extra] [SY] · Panadol Extra (acetaminophen 500 MG / caffeine 65 MG) Oral Tablet [SY]44Drug Facts20240206

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
e5c2d88a-d903-4ca0-b895-f27e791dfc4eDrug FactsHaleon US Holdings LLC20240206

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCN02BEAnilidesATC1-4acetaminophen
ATCD11AXOther dermatologicalsATC1-4caffeine
ATCN06BCXanthine derivativesATC1-4caffeine
FDASPLD014970XanthinesCHEMhas_chemical_structurecaffeine
FDASPLN0000175739Central Nervous System StimulantEPChas_epccaffeine
FDASPLN0000175790MethylxanthineEPChas_epccaffeine
FDASPLN0000175729Central Nervous System StimulationPEhas_pecaffeine
MEDRTD000082AcetaminophenCHEMhas_ingredientacetaminophen
MEDRTD002110CaffeineCHEMhas_ingredientcaffeine
MEDRTD001049ApneaDISEASEmay_treatcaffeine
MEDRTD004342Drug HypersensitivityDISEASEci_withcaffeine
MEDRTD004342Drug HypersensitivityDISEASEci_withacetaminophen
MEDRTD005221FatigueDISEASEmay_treatcaffeine
MEDRTD005334FeverDISEASEmay_preventacetaminophen
MEDRTD005334FeverDISEASEmay_treatacetaminophen
MEDRTD005955Glucosephosphate Dehydrogenase DeficiencyDISEASEci_withacetaminophen
MEDRTD008107Liver DiseasesDISEASEci_withacetaminophen
MEDRTD010146PainDISEASEmay_preventacetaminophen
MEDRTD010146PainDISEASEmay_treatacetaminophen
MEDRTN0000000133Enzyme InhibitorsMOAhas_moacaffeine
MEDRTN0000000108Prostaglandin Receptor AntagonistsMOAhas_moaacetaminophen
MEDRTN0000008322BronchodilationPEhas_pecaffeine
MEDRTN0000008331Cardiovascular Activity AlterationPEhas_pecaffeine
MEDRTN0000175724Central Nervous System Activity AlterationPEhas_peacetaminophen
MEDRTN0000008567Decreased Collecting Duct Water PermeabilityPEhas_pecaffeine
MEDRTN0000008836Decreased Prostaglandin ProductionPEhas_peacetaminophen
MEDRTN0000009072Hypothalamic Endocrine Activity AlterationPEhas_peacetaminophen
MEDRTN0000009197Increased Central Nervous System Organized Electrical ActivityPEhas_pecaffeine
MEDRTN0000175725Peripheral Nervous System Activity AlterationPEhas_peacetaminophen
MEDRTN0000000026Hepatic MetabolismPKhas_pkacetaminophen
MEDRTN0000000042Renal ExcretionPKhas_pkacetaminophen

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH500 MG / 65 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
NAMESPrescribable SynonymPanadol Extra 500 MG / 65 MG Oral Tablet
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK