FDA.reportPublic FDA data

acetaminophen 325 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 5 MG Oral Tablet

RxCUI
1046751
RxNorm name
acetaminophen 325 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 5 MG Oral Tablet
Display name
Acetaminophen/diphenhydrAMINE/Phenylephrine (Oral Pill)
Full name
acetaminophen 325 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 5 MG Oral Tablet
Term type
SCD
Status
Active
Strength
325-25-5 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-06-13 07:09:09

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
122010
Active start
122010
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
acetaminophen325 MG / 1 EACHacetaminophenacetaminophen
diphenhydramine hydrochloride25 MG / 1 EACHdiphenhydraminediphenhydramine hydrochloride
phenylephrine hydrochloride5 MG / 1 EACHphenylephrinephenylephrine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Tablet317541

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
acetaminophen161
diphenhydramine3498
phenylephrine8163

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRacetaminophen 325 MG / diphenhydrAMINE hydrochloride 25 MG / phenylephrine hydrochloride 5 MG Oral TabletNAMES
RxNorm Nameacetaminophen 325 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 5 MG Oral TabletNAMES
RxNorm SynonymAPAP 325 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 5 MG Oral TabletNAMES
TTYSCDATTRIBUTES
SPL_SET_ID0a6e3251-02e0-42c1-bdf3-51c77f88c17fCODES
SPL_SET_ID1a1f41c4-5430-4cff-873e-6547dadc8779CODES
SPL_SET_IDb3c744b8-aa93-505d-f8cf-07995da4283dCODES
RxCUI1046751CODES
MMSL_CODEBD17154CODES
MMSL_CODECD17154CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0363-5430-090363-5430Allergy Relief ACETAMINOPHEN, DIPHENHYDRAMINE HCl, PHENYLEPHRINE HClWalgreen CompanyM012
49035-543-0949035-543Severe Allergy Plus Sinus Headache Acetaminophen, Diphenhydramine HCl, Phenylephrine HClWal-Mart Stores IncM012
49035-543-4149035-543Severe Allergy Plus Sinus Headache Acetaminophen, Diphenhydramine HCl, Phenylephrine HClWal-Mart Stores IncM012
59779-543-0959779-543Severe Allergy And Sinus Headache Acetaminophen, Diphenhydramine HCl, Phenylephrine HClCVS PharmacyM012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M0120363-5430Allergy Relief ACETAMINOPHEN, DIPHENHYDRAMINE HCl, PHENYLEPHRINE HClOTC MONOGRAPH DRUGWalgreen Company

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
00363054309rxnav_ndcsyes
00363054409rxnav_ndcsyes
00363054508rxnav_ndcsyes
00363543009rxnav_ndcsyes
46122005360rxnav_ndcsyes
46122026860rxnav_ndcsyes
49035054309rxnav_ndcsyes
49035054341rxnav_ndcsyes
59779054309rxnav_ndcsyes
68016002590rxnav_ndcsyes
00045028324rxnav_historical
00363544009rxnav_historical
00501290720rxnav_historical_indirect
00501290820rxnav_historical_indirect
11822052602rxnav_historical
11822054301rxnav_historical
11822054309rxnav_historical
11822071400rxnav_historical
11822548050rxnav_historical
11917007644rxnav_historical
12547017584rxnav_historical
12547022736rxnav_historical
36800050002rxnav_historical
36800099901rxnav_historical
41250012602rxnav_historical
41250054309rxnav_historical
42507094201rxnav_historical
46122005262rxnav_historical
49781012320rxnav_historical
50580028312rxnav_historical_indirect
50580028324rxnav_historical_indirect
50580034020rxnav_historical
50580067120rxnav_historical_indirect
50804047302rxnav_historical
54473013936rxnav_historical_indirect
54473018401rxnav_historical
54473018436rxnav_historical
55312094201rxnav_historical
57344012602rxnav_historical
57344012702rxnav_historical
57344015602rxnav_historical
61715014420rxnav_historical
63824055020rxnav_historical
63868079220rxnav_historical
68016002012rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
b3c744b8-aa93-505d-f8cf-07995da4283dAPAP 325 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 5 MG Oral TabletSY18CVS 44-543-Delisted20260206
b3c744b8-aa93-505d-f8cf-07995da4283dacetaminophen 325 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD18CVS 44-543-Delisted20260206
b3c744b8-aa93-505d-f8cf-07995da4283dacetaminophen 325 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 5 MG Oral TabletPSN18CVS 44-543-Delisted20260206
1a1f41c4-5430-4cff-873e-6547dadc8779APAP 325 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 5 MG Oral TabletSY13Equate 44-54320251106
1a1f41c4-5430-4cff-873e-6547dadc8779acetaminophen 325 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 5 MG Oral TabletPSN13Equate 44-54320251106
1a1f41c4-5430-4cff-873e-6547dadc8779acetaminophen 325 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD13Equate 44-54320251106
0a6e3251-02e0-42c1-bdf3-51c77f88c17facetaminophen 325 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD6Walgreens 44-543 AR20251211
0a6e3251-02e0-42c1-bdf3-51c77f88c17facetaminophen 325 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 5 MG Oral TabletPSN6Walgreens 44-543 AR20251211
0a6e3251-02e0-42c1-bdf3-51c77f88c17fAPAP 325 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 5 MG Oral TabletSY6Walgreens 44-543 AR20251211

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
b3c744b8-aa93-505d-f8cf-07995da4283dCVS 44-543-DelistedCVS Pharmacy | LNK International, Inc.20260206
0a6e3251-02e0-42c1-bdf3-51c77f88c17fWalgreens 44-543 ARWalgreen Company | LNK International, Inc.20251211
0a6e3251-02e0-42c1-bdf3-51c77f88c17fWalgreens 44-543 ARWalgreen Company | LNK International, Inc.20251115
1a1f41c4-5430-4cff-873e-6547dadc8779Equate 44-543Wal-Mart Stores Inc | LNK International, Inc.20251106
1a1f41c4-5430-4cff-873e-6547dadc8779Equate 44-543Wal-Mart Stores Inc | LNK International, Inc.20241025

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_STRENGTH325 MG / 25 MG / 5 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESTTYSCD
CODESMMSL_CODEBD17154
CODESMMSL_CODECD17154
CODESRxCUI1046751
CODESSPL_SET_ID0a6e3251-02e0-42c1-bdf3-51c77f88c17f
CODESSPL_SET_ID1a1f41c4-5430-4cff-873e-6547dadc8779
CODESSPL_SET_IDb3c744b8-aa93-505d-f8cf-07995da4283d
NAMESPrescribable Synonymacetaminophen 325 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 5 MG Oral Tablet
NAMESRXNAV_STRacetaminophen 325 MG / diphenhydrAMINE hydrochloride 25 MG / phenylephrine hydrochloride 5 MG Oral Tablet
NAMESRxNorm Nameacetaminophen 325 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 5 MG Oral Tablet
NAMESRxNorm SynonymAPAP 325 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 5 MG Oral Tablet
NAMESTallman Synonymacetaminophen 325 MG / diphenhydrAMINE hydrochloride 25 MG / phenylephrine hydrochloride 5 MG Oral Tablet
NAMESTallman SynonymAPAP 325 MG / diphenhydrAMINE hydrochloride 25 MG / phenylephrine hydrochloride 5 MG Oral Tablet
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceNational Drug Data File Plus Source Vocabulary