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#

RxNav current and historical NDC rows page 1 of 1 · 2 matching rows.

NDC11, Source, Active table
NDC11SourceActive
66715671508rxnav_ndcsyes
66715681508rxnav_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
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Inc.5b493ed7-9044-4841-9935-236d0bdc71a92025-12-23WarningsExact identifier
ndc (package): 66715-6715-8
ndc (product): 66715-6715
ndc11 (package): 66715671508
rxcui: 1312260
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Inc.77a7ff9a-a414-4053-8d8d-369907d4380d2025-12-23WarningsExact identifier
ndc11 (package): 66715681508

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