FDA.reportPublic FDA data

acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / phenylephrine hydrochloride 5 MG Oral Capsule

RxCUI
1312260
RxNorm name
acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / phenylephrine hydrochloride 5 MG Oral Capsule
Term type
SCD
Status
Active
Updated
2026-07-21 06:59:06

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
112012
Active start
112012
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
acetaminophen325 MG / 1 EACHacetaminophenacetaminophen
dextromethorphan hydrobromide15 MG / 1 EACHdextromethorphandextromethorphan hydrobromide
phenylephrine hydrochloride5 MG / 1 EACHphenylephrinephenylephrine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Capsule316965

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
acetaminophen161
dextromethorphan3289
phenylephrine8163

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
RXNAV_STRacetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / phenylephrine hydrochloride 5 MG Oral CapsuleNAMES
RxNorm Nameacetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / phenylephrine hydrochloride 5 MG Oral CapsuleNAMES
RxNorm SynonymAPAP 325 MG / Dextromethorphan Hydrobromide 15 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleNAMES
TTYSCDATTRIBUTES
SPL_SET_ID5b493ed7-9044-4841-9935-236d0bdc71a9CODES
RxCUI1312260CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
66715-6715-866715-6715Daytime Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine HydrochlorideLil' Drug Store Products, Inc.M012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01266715-6715Daytime Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine HydrochlorideOTC MONOGRAPH DRUGLil' Drug Store Products, Inc.

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
66715671508rxnav_ndcsyes
66715681508rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
5b493ed7-9044-4841-9935-236d0bdc71a9acetaminophen 325 MG / dextromethorphan HBr 15 MG / phenylephrine HCl 5 MG Oral CapsulePSN4Daytime Cold & Flu20251223
5b493ed7-9044-4841-9935-236d0bdc71a9APAP 325 MG / Dextromethorphan Hydrobromide 15 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSY4Daytime Cold & Flu20251223
5b493ed7-9044-4841-9935-236d0bdc71a9acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD4Daytime Cold & Flu20251223

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
77a7ff9a-a414-4053-8d8d-369907d4380dDaytime Cold & FluLil' Drug Store Products, Inc.20251223
5b493ed7-9044-4841-9935-236d0bdc71a9Daytime Cold & FluLil' Drug Store Products, Inc.20251223

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCC01CAAdrenergic and dopaminergic agentsATC1-4phenylephrine
ATCN02BEAnilidesATC1-4acetaminophen
ATCR05DAOpium alkaloids and derivativesATC1-4dextromethorphan
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
FDASPLN0000182149Sigma-1 AgonistEPChas_epcdextromethorphan
FDASPLN0000181821Uncompetitive N-methyl-D-aspartate Receptor AntagonistEPChas_epcdextromethorphan
FDASPLN0000182147Sigma-1 Receptor AgonistsMOAhas_moadextromethorphan
FDASPLN0000181819Uncompetitive NMDA Receptor AntagonistsMOAhas_moadextromethorphan
MEDRTD000082AcetaminophenCHEMhas_ingredientacetaminophen
MEDRTD003915DextromethorphanCHEMhas_ingredientdextromethorphan
MEDRTD003915DextromethorphanCHEMhas_ingredientdextromethorphan hydrobromide
MEDRTD010656PhenylephrineCHEMhas_ingredientphenylephrine
MEDRTD010656PhenylephrineCHEMhas_ingredientphenylephrine hydrochloride
MEDRTD013447SulfitesCHEMci_chemclassphenylephrine
MEDRTD013447SulfitesCHEMci_chemclassphenylephrine hydrochloride
MEDRTD003371CoughDISEASEmay_treatdextromethorphan hydrobromide
MEDRTD003371CoughDISEASEmay_treatdextromethorphan
MEDRTD003371CoughDISEASEmay_preventdextromethorphan
MEDRTD003371CoughDISEASEmay_preventdextromethorphan hydrobromide
MEDRTD004342Drug HypersensitivityDISEASEci_withphenylephrine
MEDRTD004342Drug HypersensitivityDISEASEci_withdextromethorphan
MEDRTD004342Drug HypersensitivityDISEASEci_withphenylephrine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withdextromethorphan hydrobromide
MEDRTD004342Drug HypersensitivityDISEASEci_withacetaminophen
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
MEDRTD007022HypotensionDISEASEmay_treatphenylephrine hydrochloride
MEDRTD008107Liver DiseasesDISEASEci_withacetaminophen
MEDRTD015878MydriasisDISEASEinducesphenylephrine hydrochloride
MEDRTD015878MydriasisDISEASEinducesphenylephrine
MEDRTD010146PainDISEASEmay_preventacetaminophen
MEDRTD010146PainDISEASEmay_treatacetaminophen
MEDRTD011538Pruritus AniDISEASEmay_treatphenylephrine hydrochloride
MEDRTD011538Pruritus AniDISEASEmay_treatphenylephrine
MEDRTD012223Rhinitis, VasomotorDISEASEmay_treatphenylephrine hydrochloride
MEDRTD012223Rhinitis, VasomotorDISEASEmay_treatphenylephrine
MEDRTD012772Shock, SepticDISEASEmay_treatphenylephrine
MEDRTD012772Shock, SepticDISEASEmay_treatphenylephrine hydrochloride
MEDRTD013617Tachycardia, SupraventricularDISEASEmay_treatphenylephrine
MEDRTD013617Tachycardia, SupraventricularDISEASEmay_treatphenylephrine hydrochloride
MEDRTD017180Tachycardia, VentricularDISEASEci_withphenylephrine hydrochloride
MEDRTD017180Tachycardia, VentricularDISEASEci_withphenylephrine
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moaphenylephrine
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moaphenylephrine hydrochloride
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moadextromethorphan hydrobromide
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moadextromethorphan
MEDRTN0000000108Prostaglandin Receptor AntagonistsMOAhas_moaacetaminophen
MEDRTN0000000109Serotonin Uptake InhibitorsMOAhas_moadextromethorphan hydrobromide
MEDRTN0000000109Serotonin Uptake InhibitorsMOAhas_moadextromethorphan
MEDRTN0000182147Sigma-1 Receptor AgonistsMOAhas_moadextromethorphan hydrobromide
MEDRTN0000182147Sigma-1 Receptor AgonistsMOAhas_moadextromethorphan
MEDRTN0000181819Uncompetitive NMDA Receptor AntagonistsMOAhas_moadextromethorphan hydrobromide
MEDRTN0000181819Uncompetitive NMDA Receptor AntagonistsMOAhas_moadextromethorphan
MEDRTN0000175724Central Nervous System Activity AlterationPEhas_peacetaminophen
MEDRTN0000008371Conjunctival Arterial VasoconstrictionPEhas_pephenylephrine
MEDRTN0000008371Conjunctival Arterial VasoconstrictionPEhas_pephenylephrine hydrochloride
MEDRTN0000008701Decreased Medullary Respiratory DrivePEhas_pedextromethorphan hydrobromide
MEDRTN0000008701Decreased Medullary Respiratory DrivePEhas_pedextromethorphan
MEDRTN0000008896Decreased Nasal and Sinus SecretionsPEhas_pephenylephrine
MEDRTN0000008896Decreased Nasal and Sinus SecretionsPEhas_pephenylephrine hydrochloride
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 / 15 MG / 5 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESTTYSCD
CODESRxCUI1312260
CODESSPL_SET_ID5b493ed7-9044-4841-9935-236d0bdc71a9
NAMESPrescribable Synonymacetaminophen 325 MG / dextromethorphan HBr 15 MG / phenylephrine HCl 5 MG Oral Capsule
NAMESRXNAV_STRacetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / phenylephrine hydrochloride 5 MG Oral Capsule
NAMESRxNorm Nameacetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / phenylephrine hydrochloride 5 MG Oral Capsule
NAMESRxNorm SynonymAPAP 325 MG / Dextromethorphan Hydrobromide 15 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule
SOURCESSourceMetathesaurus FDA Structured Product Labels