FDA.reportPublic FDA data

acetaminophen 250 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule

RxCUI
1432488
RxNorm name
acetaminophen 250 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule
Display name
Acetaminophen/Dextromethorphan/guaiFENesin/Phenylephrine (Oral Pill)
Full name
acetaminophen 250 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule
Term type
SCD
Status
Active
Strength
250-10-200-5 mg
Dose form
Cap
Route
Oral Pill
Updated
2026-08-08 11:38:01

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
092013
Active start
092013
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
acetaminophen250 MG / 1 EACHacetaminophenacetaminophen
dextromethorphan hydrobromide10 MG / 1 EACHdextromethorphandextromethorphan hydrobromide
guaifenesin200 MG / 1 EACHguaifenesinguaifenesin
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
guaifenesin5032
phenylephrine8163

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRacetaminophen 250 MG / dextromethorphan hydrobromide 10 MG / guaiFENesin 200 MG / phenylephrine hydrochloride 5 MG Oral CapsuleNAMES
RxNorm Nameacetaminophen 250 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral CapsuleNAMES
RxNorm SynonymAPAP 250 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleNAMES
TTYSCDATTRIBUTES
SPL_SET_ID0c120569-622d-3a23-e054-00144ff88e88CODES
SPL_SET_ID0dba1329-5b0d-5688-e054-00144ff8d46cCODES
SPL_SET_ID5278a128-41ec-4494-e054-00144ff8d46cCODES
RxCUI1432488CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0280-0505-200280-0505Alka-Seltzer Plus Severe Cough Mucus and Congestion Alka-Seltzer Plus Severe Cough Mucus and CongestionBayer HealthCare LLC.M012
0280-0507-200280-0507Alka-Seltzer Plus Severe Sinus Cold and Cough Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochlorideBayer HealthCare LLC.M013

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M0120280-0505Alka-Seltzer Plus Severe Cough Mucus and Congestion Alka-Seltzer Plus Severe Cough Mucus and CongestionOTC MONOGRAPH DRUGBayer HealthCare LLC.
M0130280-0507Alka-Seltzer Plus Severe Sinus Cold and Cough Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochlorideOTC MONOGRAPH DRUGBayer HealthCare LLC.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 3 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00280050520rxnav_ndcsyes
00280050720rxnav_ndcsyes
00280115920rxnav_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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alka-Seltzer Plus Severe Cough Mucus and Congestion Liquid GelsALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTIONBayer HealthCare LLC.0c120569-622d-3a23-e054-00144ff88e882025-12-04WarningsExact identifier
ndc (package): 0280-0505-20
ndc (product): 0280-0505
ndc11 (package): 00280050520
rxcui: 1432488
Alka-Seltzer Plus Severe Sinus Cold and Cough Liquid GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.0dba1329-5b0d-5688-e054-00144ff8d46c2025-12-04WarningsExact identifier
ndc (package): 0280-0507-20
ndc (product): 0280-0507
ndc11 (package): 00280050720
rxcui: 1432488
Alka-Seltzer Plus Severe Cough Mucus and Congestion Day and NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE, GUAIFENESINBayer HealthCare LLC.5278a128-41ec-4494-e054-00144ff8d46c2025-12-04WarningsExact identifier
rxcui: 1432488

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
0c120569-622d-3a23-e054-00144ff88e88acetaminophen 250 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral CapsulePSN8Alka-seltzer Plus Severe Cough Mucus & Congestion LG20251204
0c120569-622d-3a23-e054-00144ff88e88acetaminophen 250 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD8Alka-seltzer Plus Severe Cough Mucus & Congestion LG20251204
0c120569-622d-3a23-e054-00144ff88e88APAP 250 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSY8Alka-seltzer Plus Severe Cough Mucus & Congestion LG20251204
0dba1329-5b0d-5688-e054-00144ff8d46cAPAP 250 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSY8ALKA SELTZER PLUS SEVERE SINUS COLD & COUGH20251204
0dba1329-5b0d-5688-e054-00144ff8d46cacetaminophen 250 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD8ALKA SELTZER PLUS SEVERE SINUS COLD & COUGH20251204
0dba1329-5b0d-5688-e054-00144ff8d46cacetaminophen 250 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral CapsulePSN8ALKA SELTZER PLUS SEVERE SINUS COLD & COUGH20251204
5278a128-41ec-4494-e054-00144ff8d46cAPAP 250 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSY6Alka-Seltzer Plus® Severe Cough, Mucus & Congestion Day & Night Liquid Gels20251204
5278a128-41ec-4494-e054-00144ff8d46cacetaminophen 250 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral CapsulePSN6Alka-Seltzer Plus® Severe Cough, Mucus & Congestion Day & Night Liquid Gels20251204
5278a128-41ec-4494-e054-00144ff8d46cacetaminophen 250 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD6Alka-Seltzer Plus® Severe Cough, Mucus & Congestion Day & Night Liquid Gels20251204

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
0c120569-622d-3a23-e054-00144ff88e88Alka-seltzer Plus Severe Cough Mucus & Congestion LGBayer HealthCare LLC.20251204
0dba1329-5b0d-5688-e054-00144ff8d46cALKA SELTZER PLUS SEVERE SINUS COLD & COUGHBayer HealthCare LLC. | Bayer HealthCare LLC Consumer Care20251204

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCC01CAAdrenergic and dopaminergic agentsATC1-4phenylephrine
ATCN02BEAnilidesATC1-4acetaminophen
ATCR05CAExpectorantsATC1-4guaifenesin
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
FDASPLN0000193956ExpectorantEPChas_epcguaifenesin
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
MEDRTD006140GuaifenesinCHEMhas_ingredientguaifenesin
MEDRTD010656PhenylephrineCHEMhas_ingredientphenylephrine
MEDRTD010656PhenylephrineCHEMhas_ingredientphenylephrine hydrochloride
MEDRTD013447SulfitesCHEMci_chemclassphenylephrine hydrochloride
MEDRTD013447SulfitesCHEMci_chemclassphenylephrine
MEDRTD001991BronchitisDISEASEmay_treatguaifenesin
MEDRTD003139Common ColdDISEASEmay_treatguaifenesin
MEDRTD003371CoughDISEASEmay_treatguaifenesin
MEDRTD003371CoughDISEASEmay_treatdextromethorphan hydrobromide
MEDRTD003371CoughDISEASEmay_preventdextromethorphan
MEDRTD003371CoughDISEASEmay_preventdextromethorphan hydrobromide
MEDRTD003371CoughDISEASEmay_treatdextromethorphan
MEDRTD004342Drug HypersensitivityDISEASEci_withdextromethorphan
MEDRTD004342Drug HypersensitivityDISEASEci_withphenylephrine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withdextromethorphan hydrobromide
MEDRTD004342Drug HypersensitivityDISEASEci_withacetaminophen
MEDRTD004342Drug HypersensitivityDISEASEci_withphenylephrine
MEDRTD004342Drug HypersensitivityDISEASEci_withguaifenesin
MEDRTD005334FeverDISEASEmay_treatacetaminophen
MEDRTD005334FeverDISEASEmay_preventacetaminophen
MEDRTD005401Fissure in AnoDISEASEmay_treatphenylephrine hydrochloride
MEDRTD005401Fissure in AnoDISEASEmay_treatphenylephrine
MEDRTD005902Glaucoma, Open-AngleDISEASEmay_treatphenylephrine hydrochloride
MEDRTD005902Glaucoma, Open-AngleDISEASEmay_treatphenylephrine
MEDRTD005955Glucosephosphate Dehydrogenase DeficiencyDISEASEci_withacetaminophen
MEDRTD006484HemorrhoidsDISEASEmay_treatphenylephrine
MEDRTD006484HemorrhoidsDISEASEmay_treatphenylephrine hydrochloride
MEDRTD006973HypertensionDISEASEci_withphenylephrine hydrochloride
MEDRTD006973HypertensionDISEASEci_withphenylephrine
MEDRTD007022HypotensionDISEASEmay_treatphenylephrine
MEDRTD007022HypotensionDISEASEmay_treatphenylephrine hydrochloride
MEDRTD007827LaryngitisDISEASEmay_treatguaifenesin
MEDRTD008107Liver DiseasesDISEASEci_withacetaminophen
MEDRTD015878MydriasisDISEASEinducesphenylephrine
MEDRTD015878MydriasisDISEASEinducesphenylephrine hydrochloride
MEDRTD010146PainDISEASEmay_treatacetaminophen
MEDRTD010146PainDISEASEmay_preventacetaminophen
MEDRTD010612PharyngitisDISEASEmay_treatguaifenesin
MEDRTD011538Pruritus AniDISEASEmay_treatphenylephrine
MEDRTD011538Pruritus AniDISEASEmay_treatphenylephrine hydrochloride
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatguaifenesin
MEDRTD012223Rhinitis, VasomotorDISEASEmay_treatphenylephrine
MEDRTD012223Rhinitis, VasomotorDISEASEmay_treatphenylephrine hydrochloride
MEDRTD012772Shock, SepticDISEASEmay_treatphenylephrine hydrochloride
MEDRTD012772Shock, SepticDISEASEmay_treatphenylephrine
MEDRTD012852SinusitisDISEASEmay_treatguaifenesin
MEDRTD013617Tachycardia, SupraventricularDISEASEmay_treatphenylephrine
MEDRTD013617Tachycardia, SupraventricularDISEASEmay_treatphenylephrine hydrochloride
MEDRTD017180Tachycardia, VentricularDISEASEci_withphenylephrine hydrochloride
MEDRTD017180Tachycardia, VentricularDISEASEci_withphenylephrine
MEDRTD014917Whooping CoughDISEASEmay_treatguaifenesin
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moaphenylephrine
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moaphenylephrine hydrochloride
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moadextromethorphan
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moadextromethorphan hydrobromide
MEDRTN0000000108Prostaglandin Receptor AntagonistsMOAhas_moaacetaminophen
MEDRTN0000000109Serotonin Uptake InhibitorsMOAhas_moadextromethorphan
MEDRTN0000000109Serotonin Uptake InhibitorsMOAhas_moadextromethorphan hydrobromide
MEDRTN0000182147Sigma-1 Receptor AgonistsMOAhas_moadextromethorphan hydrobromide
MEDRTN0000182147Sigma-1 Receptor AgonistsMOAhas_moadextromethorphan
MEDRTN0000181819Uncompetitive NMDA Receptor AntagonistsMOAhas_moadextromethorphan
MEDRTN0000181819Uncompetitive NMDA Receptor AntagonistsMOAhas_moadextromethorphan hydrobromide
MEDRTN0000175724Central Nervous System Activity AlterationPEhas_peacetaminophen
MEDRTN0000008371Conjunctival Arterial VasoconstrictionPEhas_pephenylephrine
MEDRTN0000008371Conjunctival Arterial VasoconstrictionPEhas_pephenylephrine hydrochloride
MEDRTN0000008701Decreased Medullary Respiratory DrivePEhas_pedextromethorphan
MEDRTN0000008701Decreased Medullary Respiratory DrivePEhas_pedextromethorphan hydrobromide
MEDRTN0000008896Decreased Nasal and Sinus SecretionsPEhas_pephenylephrine
MEDRTN0000008896Decreased Nasal and Sinus SecretionsPEhas_pephenylephrine hydrochloride
MEDRTN0000008836Decreased Prostaglandin ProductionPEhas_peacetaminophen
MEDRTN0000008867Decreased Respiratory Secretion ViscosityPEhas_peguaifenesin
MEDRTN0000009072Hypothalamic Endocrine Activity AlterationPEhas_peacetaminophen
MEDRTN0000009560Increased Respiratory SecretionsPEhas_peguaifenesin
MEDRTN0000175725Peripheral Nervous System Activity AlterationPEhas_peacetaminophen
MEDRTN0000000026Hepatic MetabolismPKhas_pkacetaminophen
MEDRTN0000000042Renal ExcretionPKhas_pkacetaminophen

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH250 MG / 10 MG / 200 MG / 5 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESTTYSCD
CODESRxCUI1432488
CODESSPL_SET_ID0c120569-622d-3a23-e054-00144ff88e88
CODESSPL_SET_ID0dba1329-5b0d-5688-e054-00144ff8d46c
CODESSPL_SET_ID5278a128-41ec-4494-e054-00144ff8d46c
NAMESPrescribable Synonymacetaminophen 250 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule
NAMESRXNAV_STRacetaminophen 250 MG / dextromethorphan hydrobromide 10 MG / guaiFENesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule
NAMESRxNorm Nameacetaminophen 250 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule
NAMESRxNorm SynonymAPAP 250 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule
NAMESTallman Synonymacetaminophen 250 MG / dextromethorphan hydrobromide 10 MG / guaiFENesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule
NAMESTallman SynonymAPAP 250 MG / Dextromethorphan Hydrobromide 10 MG / guaiFENesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK