acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution

RxCUI
1659175
RxNorm name
acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution
Display name
Acetaminophen/diphenhydrAMINE/Phenylephrine (Oral Solution Powder)
Full name
acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution
Term type
SCD
Status
Active
Strength
500-25-10 mg
Dose form
Pwdr
Route
Oral Solution Powder
Updated
2026-10-20 20:48:54

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
092015
Active start
092015
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
acetaminophen500 MG / 1 EACHacetaminophenacetaminophen
diphenhydramine hydrochloride25 MG / 1 EACHdiphenhydraminediphenhydramine hydrochloride
phenylephrine hydrochloride10 MG / 1 EACHphenylephrinephenylephrine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Powder for Oral Solution1540455

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
acetaminophen161
diphenhydramine3498
phenylephrine8163

Source Vocabulary Codes#

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0067-6801-020067-6801Theraflu Severe Cold relief Nighttime Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine HydrochlorideHaleon US Holdings LLCM012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M0120067-6801Theraflu Severe Cold relief Nighttime Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine HydrochlorideOTC MONOGRAPH DRUGHaleon US Holdings LLC

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 4 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00067680102rxnav_ndcsyes
00067812401rxnav_ndcsyes
00067812406rxnav_ndcsyes
69842070091rxnav_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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Theraflu Severe Cold relief NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC0d3b1bea-e2ca-4e07-8ae5-60627d230c962024-03-08WarningsExact identifier
ndc (package): 0067-6801-02
ndc (product): 0067-6801
ndc11 (package): 00067680102
rxcui: 1659175

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
0d3b1bea-e2ca-4e07-8ae5-60627d230c96acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Powder for Oral Solution [PSN] · acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution [SCD] · acetaminophen 500 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral [SY] · acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution [SY] · APAP 500 MG / Diphenhydramine Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Powder for Oral Solution [SY]52Drug Facts20240308

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
0d3b1bea-e2ca-4e07-8ae5-60627d230c96Drug FactsHaleon US Holdings LLC20240308
ef42d2a3-1bab-4527-8e1e-54e8749cc7b5Drug FactsGlaxoSmithKline Consumer Healthcare Holdings (US) LLC | GSK Consumer Health, Inc.20210624
cca1f854-f427-4f3d-855b-b15e27c1630cCVS Pharmacy, Inc. Multi-Symptom Severe Cold Drug FactsCVS Pharmacy20191119

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCC01CAAdrenergic and dopaminergic agentsATC1-4phenylephrine
ATCR06AAAminoalkyl ethersATC1-4diphenhydramine
ATCN02BEAnilidesATC1-4acetaminophen
ATCD04AAAntihistamines for topical useATC1-4diphenhydramine
ATCC05AXOther agents for treatment of hemorrhoids and anal fissures for topical useATC1-4phenylephrine
ATCR01BASympathomimeticsATC1-4phenylephrine
ATCS01FBSympathomimetics excl. antiglaucoma preparationsATC1-4phenylephrine
ATCS01GASympathomimetics used as decongestantsATC1-4phenylephrine
ATCR01ABSympathomimetics, combinations excl. corticosteroidsATC1-4phenylephrine
ATCR01AASympathomimetics, plainATC1-4phenylephrine
FDASPLN0000186105alpha-1 Adrenergic AgonistEPChas_epcphenylephrine
FDASPLN0000175587Histamine-1 Receptor AntagonistEPChas_epcdiphenhydramine
FDASPLN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadiphenhydramine
MEDRTD000082AcetaminophenCHEMhas_ingredientacetaminophen
MEDRTD004155DiphenhydramineCHEMhas_ingredientdiphenhydramine hydrochloride
MEDRTD004155DiphenhydramineCHEMhas_ingredientdiphenhydramine
MEDRTD010656PhenylephrineCHEMhas_ingredientphenylephrine
MEDRTD010656PhenylephrineCHEMhas_ingredientphenylephrine hydrochloride
MEDRTD013447SulfitesCHEMci_chemclassphenylephrine
MEDRTD013447SulfitesCHEMci_chemclassphenylephrine hydrochloride
MEDRTD001008Anxiety DisordersDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD001008Anxiety DisordersDISEASEmay_treatdiphenhydramine
MEDRTD004342Drug HypersensitivityDISEASEci_withdiphenhydramine
MEDRTD004342Drug HypersensitivityDISEASEci_withdiphenhydramine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withphenylephrine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withacetaminophen
MEDRTD004342Drug HypersensitivityDISEASEci_withphenylephrine
MEDRTD005334FeverDISEASEmay_treatacetaminophen
MEDRTD005334FeverDISEASEmay_preventacetaminophen
MEDRTD005401Fissure in AnoDISEASEmay_treatphenylephrine
MEDRTD005401Fissure in AnoDISEASEmay_treatphenylephrine hydrochloride
MEDRTD005902Glaucoma, Open-AngleDISEASEmay_treatphenylephrine hydrochloride
MEDRTD005902Glaucoma, Open-AngleDISEASEmay_treatphenylephrine
MEDRTD005955Glucosephosphate Dehydrogenase DeficiencyDISEASEci_withacetaminophen
MEDRTD006484HemorrhoidsDISEASEmay_treatphenylephrine hydrochloride
MEDRTD006484HemorrhoidsDISEASEmay_treatphenylephrine
MEDRTD006973HypertensionDISEASEci_withphenylephrine
MEDRTD006973HypertensionDISEASEci_withphenylephrine hydrochloride
MEDRTD007022HypotensionDISEASEmay_treatphenylephrine hydrochloride
MEDRTD007022HypotensionDISEASEmay_treatphenylephrine
MEDRTD007231Infant, NewbornDISEASEci_withdiphenhydramine hydrochloride
MEDRTD007231Infant, NewbornDISEASEci_withdiphenhydramine
MEDRTD007234Infant, PrematureDISEASEci_withdiphenhydramine hydrochloride
MEDRTD007234Infant, PrematureDISEASEci_withdiphenhydramine
MEDRTD007774LactationDISEASEci_withdiphenhydramine
MEDRTD007774LactationDISEASEci_withdiphenhydramine hydrochloride
MEDRTD008107Liver DiseasesDISEASEci_withacetaminophen
MEDRTD009041Motion SicknessDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD009041Motion SicknessDISEASEmay_treatdiphenhydramine
MEDRTD015878MydriasisDISEASEinducesphenylephrine
MEDRTD015878MydriasisDISEASEinducesphenylephrine hydrochloride
MEDRTD009325NauseaDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD009325NauseaDISEASEmay_treatdiphenhydramine
MEDRTD010146PainDISEASEmay_treatacetaminophen
MEDRTD010146PainDISEASEmay_preventacetaminophen
MEDRTD011538Pruritus AniDISEASEmay_treatphenylephrine
MEDRTD011538Pruritus AniDISEASEmay_treatphenylephrine hydrochloride
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatdiphenhydramine
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD012223Rhinitis, VasomotorDISEASEmay_treatphenylephrine
MEDRTD012223Rhinitis, VasomotorDISEASEmay_treatphenylephrine hydrochloride
MEDRTD012772Shock, SepticDISEASEmay_treatphenylephrine hydrochloride
MEDRTD012772Shock, SepticDISEASEmay_treatphenylephrine
MEDRTD007319Sleep Initiation and Maintenance DisordersDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD007319Sleep Initiation and Maintenance DisordersDISEASEmay_treatdiphenhydramine
MEDRTD012912SneezingDISEASEmay_treatdiphenhydramine
MEDRTD012912SneezingDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD013224Status AsthmaticusDISEASEci_withdiphenhydramine
MEDRTD013224Status AsthmaticusDISEASEci_withdiphenhydramine hydrochloride
MEDRTD013617Tachycardia, SupraventricularDISEASEmay_treatphenylephrine
MEDRTD013617Tachycardia, SupraventricularDISEASEmay_treatphenylephrine hydrochloride
MEDRTD017180Tachycardia, VentricularDISEASEci_withphenylephrine hydrochloride
MEDRTD017180Tachycardia, VentricularDISEASEci_withphenylephrine
MEDRTD014581UrticariaDISEASEmay_treatdiphenhydramine
MEDRTD014581UrticariaDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moaphenylephrine
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moaphenylephrine hydrochloride
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadiphenhydramine hydrochloride
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadiphenhydramine
MEDRTN0000000108Prostaglandin Receptor AntagonistsMOAhas_moaacetaminophen
MEDRTN0000175724Central Nervous System Activity AlterationPEhas_peacetaminophen
MEDRTN0000008371Conjunctival Arterial VasoconstrictionPEhas_pephenylephrine
MEDRTN0000008371Conjunctival Arterial VasoconstrictionPEhas_pephenylephrine hydrochloride
MEDRTN0000008896Decreased Nasal and Sinus SecretionsPEhas_pephenylephrine hydrochloride
MEDRTN0000008896Decreased Nasal and Sinus SecretionsPEhas_pephenylephrine
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 / 10 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
NAMESPrescribable Synonymacetaminophen 500 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Powder for Oral Solution
NAMESTallman Synonymacetaminophen 500 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral
NAMESTallman Synonymacetaminophen 500 MG / diphenhydrAMINE hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution
NAMESTallman Synonymacetaminophen 500 MG / diphenhydrAMINE hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution
NAMESTallman SynonymAPAP 500 MG / diphenhydrAMINE Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Powder for Oral Solution
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon