FDA.reportPublic FDA data

acetaminophen 325 MG / chlorpheniramine maleate 3 MG / dextromethorphan hydrobromide 30 MG / phenylephrine hydrochloride 5 MG Oral Tablet

RxCUI
1744049
RxNorm name
acetaminophen 325 MG / chlorpheniramine maleate 3 MG / dextromethorphan hydrobromide 30 MG / phenylephrine hydrochloride 5 MG Oral Tablet
Term type
SCD
Status
Active
Updated
2026-10-22 07:01:29

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
042016
Active start
042016
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
acetaminophen325 MG / 1 EACHacetaminophenacetaminophen
chlorpheniramine maleate3 MG / 1 EACHchlorpheniraminechlorpheniramine maleate
dextromethorphan hydrobromide30 MG / 1 EACHdextromethorphandextromethorphan hydrobromide
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
chlorpheniramine2400
dextromethorphan3289
phenylephrine8163

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
RXNAV_STRacetaminophen 325 MG / chlorpheniramine maleate 3 MG / dextromethorphan hydrobromide 30 MG / phenylephrine hydrochloride 5 MG Oral Tablet1NAMES
RxNorm Nameacetaminophen 325 MG / chlorpheniramine maleate 3 MG / dextromethorphan hydrobromide 30 MG / phenylephrine hydrochloride 5 MG Oral Tablet1NAMES
RxNorm SynonymAPAP 325 MG / Chlorpheniramine Maleate 3 MG / Dextromethorphan Hydrobromide 30 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_IDac4f6a39-e455-4d33-8bb8-ae8dc6ebc2f61CODES
RxCUI17440491CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
65131-111-9565131-111BRONCOCHEM Acetaminophen-Dextromethorphan HBr-Phenylephrine HCl-Chlorpheniramine MaleateLABORATORIO MAGNACHEM INTERNATIONAL SRLC200263

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
C20026365131-111BRONCOCHEM Acetaminophen-Dextromethorphan HBr-Phenylephrine HCl-Chlorpheniramine MaleateOTC MONOGRAPH DRUGLABORATORIO MAGNACHEM INTERNATIONAL SRL

RxNav Current And Historical NDCs#

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

NDC11, Source, Active table
NDC11SourceActive
65131011195rxnav_ndcsyes
65131011121rxnav_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
BRONCOCHEM COLD AND FLU CAPLETSACETAMINOPHEN-DEXTROMETHORPHAN HBR-PHENYLEPHRINE HCL-CHLORPHENIRAMINE MALEATELABORATORIO MAGNACHEM INTERNATIONAL SRLac4f6a39-e455-4d33-8bb8-ae8dc6ebc2f62024-11-26WarningsExact identifier
ndc (package): 65131-111-95
ndc (product): 65131-111
ndc11 (package): 65131011195
rxcui: 1744049

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
ac4f6a39-e455-4d33-8bb8-ae8dc6ebc2f6acetaminophen 325 MG / chlorpheniramine maleate 3 MG / dextromethorphan HBr 30 MG / phenylephrine HCl 5 MG Oral Tablet [PSN] · acetaminophen 325 MG / chlorpheniramine maleate 3 MG / dextromethorphan hydrobromide 30 MG / phenylephrine hydrochloride 5 MG Oral Tablet [SCD] · APAP 325 MG / Chlorpheniramine Maleate 3 MG / Dextromethorphan Hydrobromide 30 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet [SY]34BRONCOCHEM COLD & FLU CAPLETS20241126

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
ac4f6a39-e455-4d33-8bb8-ae8dc6ebc2f6BRONCOCHEM COLD & FLU CAPLETSLABORATORIO MAGNACHEM INTERNATIONAL SRL20241126

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
ATCR06ABSubstituted alkylaminesATC1-4chlorpheniramine
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_epcchlorpheniramine
FDASPLN0000182149Sigma-1 AgonistEPChas_epcdextromethorphan
FDASPLN0000181821Uncompetitive N-methyl-D-aspartate Receptor AntagonistEPChas_epcdextromethorphan
FDASPLN0000182147Sigma-1 Receptor AgonistsMOAhas_moadextromethorphan
FDASPLN0000181819Uncompetitive NMDA Receptor AntagonistsMOAhas_moadextromethorphan
MEDRTD000082AcetaminophenCHEMhas_ingredientacetaminophen
MEDRTD002744ChlorpheniramineCHEMhas_ingredientchlorpheniramine maleate
MEDRTD002744ChlorpheniramineCHEMhas_ingredientchlorpheniramine
MEDRTD003915DextromethorphanCHEMhas_ingredientdextromethorphan
MEDRTD003915DextromethorphanCHEMhas_ingredientdextromethorphan hydrobromide
MEDRTD010656PhenylephrineCHEMhas_ingredientphenylephrine
MEDRTD010656PhenylephrineCHEMhas_ingredientphenylephrine hydrochloride
MEDRTD013447SulfitesCHEMci_chemclassphenylephrine
MEDRTD013447SulfitesCHEMci_chemclassphenylephrine hydrochloride
MEDRTD003371CoughDISEASEmay_treatdextromethorphan
MEDRTD003371CoughDISEASEmay_preventdextromethorphan
MEDRTD003371CoughDISEASEmay_treatdextromethorphan hydrobromide
MEDRTD003371CoughDISEASEmay_preventdextromethorphan hydrobromide
MEDRTD004342Drug HypersensitivityDISEASEci_withphenylephrine
MEDRTD004342Drug HypersensitivityDISEASEci_withdextromethorphan hydrobromide
MEDRTD004342Drug HypersensitivityDISEASEci_withacetaminophen
MEDRTD004342Drug HypersensitivityDISEASEci_withdextromethorphan
MEDRTD004342Drug HypersensitivityDISEASEci_withchlorpheniramine maleate
MEDRTD004342Drug HypersensitivityDISEASEci_withchlorpheniramine
MEDRTD004342Drug HypersensitivityDISEASEci_withphenylephrine hydrochloride
MEDRTD004380Duodenal ObstructionDISEASEci_withchlorpheniramine maleate
MEDRTD004380Duodenal ObstructionDISEASEci_withchlorpheniramine
MEDRTD005334FeverDISEASEmay_preventacetaminophen
MEDRTD005334FeverDISEASEmay_treatacetaminophen
MEDRTD005401Fissure in AnoDISEASEmay_treatphenylephrine
MEDRTD005401Fissure in AnoDISEASEmay_treatphenylephrine hydrochloride
MEDRTD015812Glaucoma, Angle-ClosureDISEASEci_withchlorpheniramine maleate
MEDRTD015812Glaucoma, Angle-ClosureDISEASEci_withchlorpheniramine
MEDRTD005902Glaucoma, Open-AngleDISEASEmay_treatphenylephrine
MEDRTD005902Glaucoma, Open-AngleDISEASEmay_treatphenylephrine hydrochloride
MEDRTD005955Glucosephosphate Dehydrogenase DeficiencyDISEASEci_withacetaminophen
MEDRTD006484HemorrhoidsDISEASEmay_treatphenylephrine
MEDRTD006484HemorrhoidsDISEASEmay_treatphenylephrine hydrochloride
MEDRTD006973HypertensionDISEASEci_withphenylephrine hydrochloride
MEDRTD006973HypertensionDISEASEci_withphenylephrine
MEDRTD007022HypotensionDISEASEmay_treatphenylephrine
MEDRTD007022HypotensionDISEASEmay_treatphenylephrine hydrochloride
MEDRTD007231Infant, NewbornDISEASEci_withchlorpheniramine maleate
MEDRTD007231Infant, NewbornDISEASEci_withchlorpheniramine
MEDRTD007234Infant, PrematureDISEASEci_withchlorpheniramine maleate
MEDRTD007234Infant, PrematureDISEASEci_withchlorpheniramine
MEDRTD008107Liver DiseasesDISEASEci_withacetaminophen
MEDRTD015878MydriasisDISEASEinducesphenylephrine hydrochloride
MEDRTD015878MydriasisDISEASEinducesphenylephrine
MEDRTD010146PainDISEASEmay_treatacetaminophen
MEDRTD010146PainDISEASEmay_preventacetaminophen
MEDRTD010437Peptic UlcerDISEASEci_withchlorpheniramine maleate
MEDRTD010437Peptic UlcerDISEASEci_withchlorpheniramine
MEDRTD011470Prostatic HyperplasiaDISEASEci_withchlorpheniramine
MEDRTD011470Prostatic HyperplasiaDISEASEci_withchlorpheniramine maleate
MEDRTD011538Pruritus AniDISEASEmay_treatphenylephrine
MEDRTD011538Pruritus AniDISEASEmay_treatphenylephrine hydrochloride
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatchlorpheniramine
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatchlorpheniramine maleate
MEDRTD012223Rhinitis, VasomotorDISEASEmay_treatphenylephrine
MEDRTD012223Rhinitis, VasomotorDISEASEmay_treatphenylephrine hydrochloride
MEDRTD012772Shock, SepticDISEASEmay_treatphenylephrine hydrochloride
MEDRTD012772Shock, SepticDISEASEmay_treatphenylephrine
MEDRTD013224Status AsthmaticusDISEASEci_withchlorpheniramine
MEDRTD013224Status AsthmaticusDISEASEci_withchlorpheniramine maleate
MEDRTD013617Tachycardia, SupraventricularDISEASEmay_treatphenylephrine hydrochloride
MEDRTD013617Tachycardia, SupraventricularDISEASEmay_treatphenylephrine
MEDRTD017180Tachycardia, VentricularDISEASEci_withphenylephrine
MEDRTD017180Tachycardia, VentricularDISEASEci_withphenylephrine hydrochloride
MEDRTD001748Urinary Bladder Neck ObstructionDISEASEci_withchlorpheniramine
MEDRTD001748Urinary Bladder Neck ObstructionDISEASEci_withchlorpheniramine maleate
MEDRTD014581UrticariaDISEASEmay_treatchlorpheniramine
MEDRTD014581UrticariaDISEASEmay_treatchlorpheniramine maleate
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moaphenylephrine
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moaphenylephrine hydrochloride
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moachlorpheniramine
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moachlorpheniramine maleate
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moadextromethorphan
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moadextromethorphan hydrobromide
MEDRTN0000000108Prostaglandin Receptor AntagonistsMOAhas_moaacetaminophen
MEDRTN0000000109Serotonin Uptake InhibitorsMOAhas_moadextromethorphan hydrobromide
MEDRTN0000000109Serotonin Uptake InhibitorsMOAhas_moadextromethorphan
MEDRTN0000182147Sigma-1 Receptor AgonistsMOAhas_moadextromethorphan
MEDRTN0000182147Sigma-1 Receptor AgonistsMOAhas_moadextromethorphan hydrobromide
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
MEDRTN0000008657Decreased Histamine ActivityPEhas_pechlorpheniramine maleate
MEDRTN0000008657Decreased Histamine ActivityPEhas_pechlorpheniramine
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 / 3 MG / 30 MG / 5 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
NAMESPrescribable Synonymacetaminophen 325 MG / chlorpheniramine maleate 3 MG / dextromethorphan HBr 30 MG / phenylephrine HCl 5 MG Oral Tablet
SOURCESSourceMetathesaurus FDA Structured Product Labels