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, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRAPAP 500 MG / diphenhydrAMINE Hydrochloride 25 MG Oral Tablet [Panadol PM]1NAMES
RxNorm Nameacetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet [Panadol PM]1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID
2 linked values
2CODES
RxCUI10947181CODES

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#

RxNav current and historical NDC rows page 1 of 1 · 11 matching rows.

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

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PANADOL PMACETAMINOPHEN AND DIPHENHYDRAMINE HCLHaleon US Holdings LLC01e7dddb-755c-4745-b701-edcdb62090642024-02-06Warnings, Adverse reactionsExact identifier
ndc (package): 0135-0608-01
ndc (package): 0135-0608-03
ndc (package): 0135-0608-02
ndc (product): 0135-0608
ndc11 (package): 00135060803
ndc11 (package): 00135060802
ndc11 (package): 00135060804
ndc11 (package): 00135060801
rxcui: 1094718
PANADOL PMACETAMINOPHEN AND DIPHENHYDRAMINE HCLHaleon US Holdings LLCfe7cd1f2-9b00-4ded-99c2-8a152c71093c2024-02-06Warnings, Adverse reactionsExact identifier
ndc (package): 0135-7021-01
ndc (package): 0135-7021-02
ndc (package): 0135-7021-03
ndc (product): 0135-7021
ndc11 (package): 00135702101
ndc11 (package): 00135702102
ndc11 (package): 00135702103
rxcui: 1094718

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
01e7dddb-755c-4745-b701-edcdb6209064Panadol PM EXTRA STRENGTH 500 MG / 25 MG Oral Tablet [PSN] · acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet [Panadol PM] [SBD] · APAP 500 MG / Diphenhydramine Hydrochloride 25 MG Oral Tablet [Panadol PM] [SY] · Panadol PM (APAP 500 MG / diphenhydramine hydrochloride 25 MG) Oral Tablet [SY]47Drug Facts20240206
fe7cd1f2-9b00-4ded-99c2-8a152c71093cPanadol PM EXTRA STRENGTH 500 MG / 25 MG Oral Tablet [PSN] · acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet [Panadol PM] [SBD] · APAP 500 MG / Diphenhydramine Hydrochloride 25 MG Oral Tablet [Panadol PM] [SY] · Panadol PM (APAP 500 MG / diphenhydramine hydrochloride 25 MG) Oral Tablet [SY]44Drug Facts20240206

Recently Linked 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
ATTRIBUTESRXNAV_HUMAN_DRUGUS
NAMESPrescribable SynonymPanadol PM EXTRA STRENGTH 500 MG / 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