FDA.reportPublic FDA data

acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule

RxCUI
1193292
RxNorm name
acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule
Term type
SCD
Status
Active
Updated
2026-07-17 22:19:15

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
122011
Active start
122011
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
acetaminophen250 MG / 1 EACHacetaminophenacetaminophen
chlorpheniramine maleate2 MG / 1 EACHchlorpheniraminechlorpheniramine maleate
dextromethorphan hydrobromide10 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
chlorpheniramine2400
dextromethorphan3289
phenylephrine8163

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
RXNAV_STRacetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleNAMES
RxNorm Nameacetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleNAMES
RxNorm SynonymAPAP 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleNAMES
TTYSCDATTRIBUTES
SPL_SET_ID0670c33e-8a3c-ae00-e063-6294a90a165bCODES
SPL_SET_ID4af8a566-5251-4d46-8692-87a3a0748334CODES
SPL_SET_IDda5b31dd-becd-471a-9392-d0ee4b8f9539CODES
RxCUI1193292CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
48201-001-1248201-001Sanaflu Xtra ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEGRANDALL DISTRIBUTING, LLCM013
55758-407-1255758-407Tabcin Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl,Pharmadel LLCM012
63654-800-0663654-800Cough and Cold Acetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine HydrochlorideSelder, S.A. de C.V.M012
63654-800-1263654-800Cough and Cold Acetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine HydrochlorideSelder, S.A. de C.V.M012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01348201-001Sanaflu Xtra ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEOTC MONOGRAPH DRUGGRANDALL DISTRIBUTING, LLC
M01255758-407Tabcin Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl,OTC MONOGRAPH DRUGPharmadel LLC

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
48201000112rxnav_ndcsyes
55758040712rxnav_ndcsyes
63654080006rxnav_ndcsyes
63654080012rxnav_ndcsyes
28623025001rxnav_historical
28623025006rxnav_historical
28623025012rxnav_historical
55758004308rxnav_historical
58596000106rxnav_historical
58596000112rxnav_historical
63654080020rxnav_historical
69517011208rxnav_historical
69517011211rxnav_historical
69772044001rxnav_historical
69772044002rxnav_historical
72365001112rxnav_historical
76095001506rxnav_historical
76095001512rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
0670c33e-8a3c-ae00-e063-6294a90a165bAPAP 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY12Tabcin Antigrip Softgel (HHH)(DA)20251205
0670c33e-8a3c-ae00-e063-6294a90a165bacetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD12Tabcin Antigrip Softgel (HHH)(DA)20251205
0670c33e-8a3c-ae00-e063-6294a90a165bacetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSN12Tabcin Antigrip Softgel (HHH)(DA)20251205
4af8a566-5251-4d46-8692-87a3a0748334acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSN10Grandall (as PLD) - Sanaflu Xtra (48201-001)20251028
4af8a566-5251-4d46-8692-87a3a0748334acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD10Grandall (as PLD) - Sanaflu Xtra (48201-001)20251028
4af8a566-5251-4d46-8692-87a3a0748334APAP 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY10Grandall (as PLD) - Sanaflu Xtra (48201-001)20251028
da5b31dd-becd-471a-9392-d0ee4b8f9539APAP 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY6XL3LqijelActmnphnChlrphnrminDxtrmthrphnPhnylphrn20241017
da5b31dd-becd-471a-9392-d0ee4b8f9539acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD6XL3LqijelActmnphnChlrphnrminDxtrmthrphnPhnylphrn20241017
da5b31dd-becd-471a-9392-d0ee4b8f9539acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSN6XL3LqijelActmnphnChlrphnrminDxtrmthrphnPhnylphrn20241017
1d878c3c-dd0e-4024-ac98-7053748d164bacetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSN5XL-3* Xtra Cold and Cough20221128
1d878c3c-dd0e-4024-ac98-7053748d164bacetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD5XL-3* Xtra Cold and Cough20221128
1d878c3c-dd0e-4024-ac98-7053748d164bAPAP 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY5XL-3* Xtra Cold and Cough20221128
1cbb8491-6ef7-45af-e054-00144ff88e88acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSN120150807
1cbb8491-6ef7-45af-e054-00144ff88e88acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD120150807
1cbb8491-6ef7-45af-e054-00144ff88e88APAP 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY120150807

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
0670c33e-8a3c-ae00-e063-6294a90a165bTabcin Antigrip Softgel (HHH)(DA)Pharmadel LLC20251205
4af8a566-5251-4d46-8692-87a3a0748334Grandall (as PLD) - Sanaflu Xtra (48201-001)GRANDALL DISTRIBUTING, LLC20251028
da5b31dd-becd-471a-9392-d0ee4b8f9539XL3LqijelActmnphnChlrphnrminDxtrmthrphnPhnylphrnSelder, S.A. de C.V.20241017
4af8a566-5251-4d46-8692-87a3a0748334Grandall (as PLD) - Sanaflu Xtra (48201-001)GRANDALL DISTRIBUTING, LLC20240123
1d878c3c-dd0e-4024-ac98-7053748d164bXL-3* Xtra Cold and CoughProgela, S.A. de C.V.20221128
1cbb8491-6ef7-45af-e054-00144ff88e88Teresa Cecena DBA Genesis | Teresa Cecena | Selder SA DE CV20150807

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_STRENGTH250 MG / 2 MG / 10 MG / 5 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESTTYSCD
CODESRxCUI1193292
CODESSPL_SET_ID0670c33e-8a3c-ae00-e063-6294a90a165b
CODESSPL_SET_ID4af8a566-5251-4d46-8692-87a3a0748334
CODESSPL_SET_IDda5b31dd-becd-471a-9392-d0ee4b8f9539
NAMESPrescribable Synonymacetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule
NAMESRXNAV_STRacetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule
NAMESRxNorm Nameacetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule
NAMESRxNorm SynonymAPAP 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule
SOURCESSourceMetathesaurus FDA Structured Product Labels