FDA.reportPublic FDA data

acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet [Panadol PM]

RxCUI
1094718
RxNorm name
acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet [Panadol PM]
Display name
PANADOL PM (Oral Pill)
Full name
acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet [Panadol PM]
Term type
SBD
Status
Active
Strength
500-25 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-07-25 06:54:33

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
052011
Active start
052011
Multiple ingredient
YES
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
acetaminophen500 MG / 1 EACHacetaminophenacetaminophen
diphenhydramine hydrochloride25 MG / 1 EACHdiphenhydraminediphenhydramine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Tablet317541

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
acetaminophen161
diphenhydramine3498

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRAPAP 500 MG / diphenhydrAMINE Hydrochloride 25 MG Oral Tablet [Panadol PM]NAMES
RxNorm Nameacetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet [Panadol PM]NAMES
RxNorm SynonymAPAP 500 MG / Diphenhydramine Hydrochloride 25 MG Oral Tablet [Panadol PM]NAMES
RxNorm SynonymPanadol PM (APAP 500 MG / diphenhydramine hydrochloride 25 MG) Oral TabletNAMES
TTYSBDATTRIBUTES
SPL_SET_ID01e7dddb-755c-4745-b701-edcdb6209064CODES
SPL_SET_IDfe7cd1f2-9b00-4ded-99c2-8a152c71093cCODES
RxCUI1094718CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0135-0608-010135-0608PANADOL acetaminophen and diphenhydramine HClHaleon US Holdings LLCM013
0135-0608-020135-0608PANADOL acetaminophen and diphenhydramine HClHaleon US Holdings LLCM013
0135-0608-030135-0608PANADOL acetaminophen and diphenhydramine HClHaleon US Holdings LLCM013
0135-7021-010135-7021PANADOL acetaminophen and diphenhydramine HClHaleon US Holdings LLCM013
0135-7021-020135-7021PANADOL acetaminophen and diphenhydramine HClHaleon US Holdings LLCM013
0135-7021-030135-7021PANADOL acetaminophen and diphenhydramine HClHaleon US Holdings LLCM013

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M0130135-0608PANADOL acetaminophen and diphenhydramine HClOTC MONOGRAPH DRUGHaleon US Holdings LLC

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
00135060801rxnav_ndcsyes
00135060802rxnav_ndcsyes
00135060803rxnav_ndcsyes
00135060804rxnav_ndcsyes
00135702101rxnav_ndcsyes
00135702102rxnav_ndcsyes
00135702103rxnav_ndcsyes
00135015001rxnav_historical
00135015002rxnav_historical
00135015003rxnav_historical
00135015004rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
01e7dddb-755c-4745-b701-edcdb6209064acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet [Panadol PM]SBD7Drug Facts20240206
01e7dddb-755c-4745-b701-edcdb6209064Panadol PM EXTRA STRENGTH 500 MG / 25 MG Oral TabletPSN7Drug Facts20240206
01e7dddb-755c-4745-b701-edcdb6209064APAP 500 MG / Diphenhydramine Hydrochloride 25 MG Oral Tablet [Panadol PM]SY7Drug Facts20240206
01e7dddb-755c-4745-b701-edcdb6209064Panadol PM (APAP 500 MG / diphenhydramine hydrochloride 25 MG) Oral TabletSY7Drug Facts20240206
fe7cd1f2-9b00-4ded-99c2-8a152c71093cPanadol PM EXTRA STRENGTH 500 MG / 25 MG Oral TabletPSN4Drug Facts20240206
fe7cd1f2-9b00-4ded-99c2-8a152c71093cacetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet [Panadol PM]SBD4Drug Facts20240206
fe7cd1f2-9b00-4ded-99c2-8a152c71093cPanadol PM (APAP 500 MG / diphenhydramine hydrochloride 25 MG) Oral TabletSY4Drug Facts20240206
fe7cd1f2-9b00-4ded-99c2-8a152c71093cAPAP 500 MG / Diphenhydramine Hydrochloride 25 MG Oral Tablet [Panadol PM]SY4Drug Facts20240206

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
01e7dddb-755c-4745-b701-edcdb6209064Drug FactsHaleon US Holdings LLC20240206
fe7cd1f2-9b00-4ded-99c2-8a152c71093cDrug FactsHaleon US Holdings LLC20240206

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCR06AAAminoalkyl ethersATC1-4diphenhydramine
ATCN02BEAnilidesATC1-4acetaminophen
ATCD04AAAntihistamines for topical useATC1-4diphenhydramine
FDASPLN0000175587Histamine-1 Receptor AntagonistEPChas_epcdiphenhydramine
FDASPLN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadiphenhydramine
MEDRTD000082AcetaminophenCHEMhas_ingredientacetaminophen
MEDRTD004155DiphenhydramineCHEMhas_ingredientdiphenhydramine hydrochloride
MEDRTD004155DiphenhydramineCHEMhas_ingredientdiphenhydramine
MEDRTD001008Anxiety DisordersDISEASEmay_treatdiphenhydramine
MEDRTD001008Anxiety DisordersDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withdiphenhydramine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withacetaminophen
MEDRTD004342Drug HypersensitivityDISEASEci_withdiphenhydramine
MEDRTD005334FeverDISEASEmay_preventacetaminophen
MEDRTD005334FeverDISEASEmay_treatacetaminophen
MEDRTD005955Glucosephosphate Dehydrogenase DeficiencyDISEASEci_withacetaminophen
MEDRTD007231Infant, NewbornDISEASEci_withdiphenhydramine hydrochloride
MEDRTD007231Infant, NewbornDISEASEci_withdiphenhydramine
MEDRTD007234Infant, PrematureDISEASEci_withdiphenhydramine hydrochloride
MEDRTD007234Infant, PrematureDISEASEci_withdiphenhydramine
MEDRTD007774LactationDISEASEci_withdiphenhydramine hydrochloride
MEDRTD007774LactationDISEASEci_withdiphenhydramine
MEDRTD008107Liver DiseasesDISEASEci_withacetaminophen
MEDRTD009041Motion SicknessDISEASEmay_treatdiphenhydramine
MEDRTD009041Motion SicknessDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD009325NauseaDISEASEmay_treatdiphenhydramine
MEDRTD009325NauseaDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD010146PainDISEASEmay_treatacetaminophen
MEDRTD010146PainDISEASEmay_preventacetaminophen
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatdiphenhydramine
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD007319Sleep Initiation and Maintenance DisordersDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD007319Sleep Initiation and Maintenance DisordersDISEASEmay_treatdiphenhydramine
MEDRTD012912SneezingDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD012912SneezingDISEASEmay_treatdiphenhydramine
MEDRTD013224Status AsthmaticusDISEASEci_withdiphenhydramine hydrochloride
MEDRTD013224Status AsthmaticusDISEASEci_withdiphenhydramine
MEDRTD014581UrticariaDISEASEmay_treatdiphenhydramine
MEDRTD014581UrticariaDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadiphenhydramine hydrochloride
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadiphenhydramine
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_STRENGTH500 MG / 25 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESTTYSBD
CODESRxCUI1094718
CODESSPL_SET_ID01e7dddb-755c-4745-b701-edcdb6209064
CODESSPL_SET_IDfe7cd1f2-9b00-4ded-99c2-8a152c71093c
NAMESPrescribable SynonymPanadol PM EXTRA STRENGTH 500 MG / 25 MG Oral Tablet
NAMESRXNAV_STRAPAP 500 MG / diphenhydrAMINE Hydrochloride 25 MG Oral Tablet [Panadol PM]
NAMESRxNorm Nameacetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet [Panadol PM]
NAMESRxNorm SynonymAPAP 500 MG / Diphenhydramine Hydrochloride 25 MG Oral Tablet [Panadol PM]
NAMESRxNorm SynonymPanadol PM (APAP 500 MG / diphenhydramine hydrochloride 25 MG) Oral Tablet
NAMESTallman Synonymacetaminophen 500 MG / diphenhydrAMINE hydrochloride 25 MG Oral Tablet [Panadol PM]
NAMESTallman SynonymAPAP 500 MG / diphenhydrAMINE Hydrochloride 25 MG Oral Tablet [Panadol PM]
NAMESTallman SynonymPanadol PM (APAP 500 MG / diphenhydrAMINE hydrochloride 25 MG) Oral Tablet
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK