FDA.reportPublic FDA data

acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / doxylamine succinate 12.5 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution

RxCUI
1534835
RxNorm name
acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / doxylamine succinate 12.5 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution
Display name
Acetaminophen/Dextromethorphan/Doxylamine/Phenylephrine (Oral Solution Powder)
Full name
acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / doxylamine succinate 12.5 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution
Term type
SCD
Status
Active
Strength
650-20-12.5-10 mg
Dose form
Pwdr
Route
Oral Solution Powder
Updated
2026-09-09 14:43:08

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
052014
Active start
052014
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
acetaminophen650 MG / 1 EACHacetaminophenacetaminophen
dextromethorphan hydrobromide20 MG / 1 EACHdextromethorphandextromethorphan hydrobromide
doxylamine succinate12.5 MG / 1 EACHdoxylaminedoxylamine succinate
phenylephrine hydrochloride10 MG / 1 EACHphenylephrinephenylephrine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Powder for Oral Solution1540455

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
acetaminophen161
dextromethorphan3289
doxylamine3642
phenylephrine8163

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRacetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / doxylamine succinate 12.5 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution1NAMES
RxNorm Nameacetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / doxylamine succinate 12.5 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
5 linked values
5CODES
RxCUI15348351CODES
MMSL_CODE
2 linked values
2CODES

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 4 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00280092206rxnav_ndcsyes
00280827206rxnav_ndcsyes
16500055939rxnav_ndcsyes
11822076301rxnav_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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SEVERE COLD PLUS FLU DAYTIME NIGHTTIMEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATECVS Pharmacy,Inc.6cb1d08b-e544-4084-b9ed-1e0d99a709c82026-08-14Warnings, Adverse reactionsExact identifier
rxcui: 1534835
ALKA SELTZER COLD Cold Flu Congestion Severe Fast Hot Liquid Day NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATEBayer HealthCare LLC.53715ea4-42b3-5887-e063-6294a90a42492026-06-04WarningsExact identifier
rxcui: 1534835
ALKA SELTZER COLD Cold and Flu plus Congestion Severe Fast Hot Liquid NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.5349dbde-730c-610f-e063-6394a90a952a2026-06-02WarningsExact identifier
ndc11 (package): 00280827206
rxcui: 1534835
Alka-Seltzer Plus Night Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.f4c60ca1-ba59-4a92-84a5-6ba65faa56ab2026-01-08WarningsExact identifier
ndc11 (package): 00280092206
rxcui: 1534835
severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLRite Aid Corporation9a71e8eb-4195-4694-bf3e-44f691ff2cef2024-10-30WarningsExact identifier
ndc11 (package): 11822076301

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 · 3 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
f4c60ca1-ba59-4a92-84a5-6ba65faa56abacetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG Powder for Oral Solution [PSN] · acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / doxylamine succinate 12.5 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution [SCD] · acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / doxylamine succinate 12.5 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution [SY] · APAP 650 MG / Dextromethorphan Hydrobromide 20 MG / doxylamine succinate 12.5 MG / Phenylephrine Hydrochloride 10 MG Powder for Oral Solution [SY]410Alka-Seltzer Plus ® Night Severe Cold + Flu20260108
6cb1d08b-e544-4084-b9ed-1e0d99a709c8acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG Powder for Oral Solution [PSN] · acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / doxylamine succinate 12.5 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution [SCD] · acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / doxylamine succinate 12.5 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution [SY] · APAP 650 MG / Dextromethorphan Hydrobromide 20 MG / doxylamine succinate 12.5 MG / Phenylephrine Hydrochloride 10 MG Powder for Oral Solution [SY]48CVS Health ™ Severe Cold & Flu Daytime and Nighttime20251208
c7a4e6ad-7315-47bf-ae91-cc511da73734acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG Powder for Oral Solution [PSN] · acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / doxylamine succinate 12.5 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution [SCD] · acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / doxylamine succinate 12.5 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution [SY] · APAP 650 MG / Dextromethorphan Hydrobromide 20 MG / doxylamine succinate 12.5 MG / Phenylephrine Hydrochloride 10 MG Powder for Oral Solution [SY]48Alka-Seltzer Plus ® Day & Night Severe Cold and Flu20240109

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
5349dbde-730c-610f-e063-6394a90a952aALKA SELTZER COLD Cold and Flu plus Congestion Severe Fast Hot Liquid Night UI1611711Bayer HealthCare LLC. | Contract Pharmacal Corp.20260602
f4c60ca1-ba59-4a92-84a5-6ba65faa56abAlka-Seltzer Plus ® Night Severe Cold + FluBayer HealthCare LLC. | Contract Pharmacal Corp.20260108
9a71e8eb-4195-4694-bf3e-44f691ff2cefRite Aid Corporation Severe Cold & Flu Relief Drug FactsRite Aid Corporation20241030

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCC01CAAdrenergic and dopaminergic agentsATC1-4phenylephrine
ATCR06AAAminoalkyl ethersATC1-4doxylamine
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
FDASPLN0000175750AntihistamineEPChas_epcdoxylamine
FDASPLN0000182149Sigma-1 AgonistEPChas_epcdextromethorphan
FDASPLN0000181821Uncompetitive N-methyl-D-aspartate Receptor AntagonistEPChas_epcdextromethorphan
FDASPLN0000000207Histamine Receptor AntagonistsMOAhas_moadoxylamine
FDASPLN0000182147Sigma-1 Receptor AgonistsMOAhas_moadextromethorphan
FDASPLN0000181819Uncompetitive NMDA Receptor AntagonistsMOAhas_moadextromethorphan
MEDRTD000082AcetaminophenCHEMhas_ingredientacetaminophen
MEDRTD003915DextromethorphanCHEMhas_ingredientdextromethorphan hydrobromide
MEDRTD003915DextromethorphanCHEMhas_ingredientdextromethorphan
MEDRTD004319DoxylamineCHEMhas_ingredientdoxylamine
MEDRTD004319DoxylamineCHEMhas_ingredientdoxylamine succinate
MEDRTD010656PhenylephrineCHEMhas_ingredientphenylephrine
MEDRTD010656PhenylephrineCHEMhas_ingredientphenylephrine hydrochloride
MEDRTD013447SulfitesCHEMci_chemclassphenylephrine hydrochloride
MEDRTD013447SulfitesCHEMci_chemclassphenylephrine
MEDRTD003371CoughDISEASEmay_treatdextromethorphan
MEDRTD003371CoughDISEASEmay_treatdextromethorphan hydrobromide
MEDRTD003371CoughDISEASEmay_preventdextromethorphan
MEDRTD003371CoughDISEASEmay_preventdextromethorphan hydrobromide
MEDRTD004342Drug HypersensitivityDISEASEci_withdoxylamine
MEDRTD004342Drug HypersensitivityDISEASEci_withphenylephrine
MEDRTD004342Drug HypersensitivityDISEASEci_withdextromethorphan
MEDRTD004342Drug HypersensitivityDISEASEci_withdoxylamine succinate
MEDRTD004342Drug HypersensitivityDISEASEci_withacetaminophen
MEDRTD004342Drug HypersensitivityDISEASEci_withdextromethorphan hydrobromide
MEDRTD004342Drug HypersensitivityDISEASEci_withphenylephrine hydrochloride
MEDRTD005334FeverDISEASEmay_preventacetaminophen
MEDRTD005334FeverDISEASEmay_treatacetaminophen
MEDRTD005401Fissure in AnoDISEASEmay_treatphenylephrine
MEDRTD005401Fissure in AnoDISEASEmay_treatphenylephrine hydrochloride
MEDRTD005902Glaucoma, Open-AngleDISEASEmay_treatphenylephrine hydrochloride
MEDRTD005902Glaucoma, Open-AngleDISEASEmay_treatphenylephrine
MEDRTD005955Glucosephosphate Dehydrogenase DeficiencyDISEASEci_withacetaminophen
MEDRTD006261HeadacheDISEASEmay_treatdoxylamine succinate
MEDRTD006261HeadacheDISEASEmay_treatdoxylamine
MEDRTD006484HemorrhoidsDISEASEmay_treatphenylephrine
MEDRTD006484HemorrhoidsDISEASEmay_treatphenylephrine hydrochloride
MEDRTD006973HypertensionDISEASEci_withphenylephrine hydrochloride
MEDRTD006973HypertensionDISEASEci_withphenylephrine
MEDRTD007022HypotensionDISEASEmay_treatphenylephrine
MEDRTD007022HypotensionDISEASEmay_treatphenylephrine hydrochloride
MEDRTD008107Liver DiseasesDISEASEci_withacetaminophen
MEDRTD015878MydriasisDISEASEinducesphenylephrine
MEDRTD015878MydriasisDISEASEinducesphenylephrine hydrochloride
MEDRTD010146PainDISEASEmay_treatacetaminophen
MEDRTD010146PainDISEASEmay_preventacetaminophen
MEDRTD011538Pruritus AniDISEASEmay_treatphenylephrine
MEDRTD011538Pruritus AniDISEASEmay_treatphenylephrine hydrochloride
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatdoxylamine succinate
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatdoxylamine
MEDRTD012223Rhinitis, VasomotorDISEASEmay_treatphenylephrine
MEDRTD012223Rhinitis, VasomotorDISEASEmay_treatphenylephrine hydrochloride
MEDRTD012772Shock, SepticDISEASEmay_treatphenylephrine hydrochloride
MEDRTD012772Shock, SepticDISEASEmay_treatphenylephrine
MEDRTD007319Sleep Initiation and Maintenance DisordersDISEASEmay_treatdoxylamine succinate
MEDRTD007319Sleep Initiation and Maintenance DisordersDISEASEmay_treatdoxylamine
MEDRTD013617Tachycardia, SupraventricularDISEASEmay_treatphenylephrine
MEDRTD013617Tachycardia, SupraventricularDISEASEmay_treatphenylephrine hydrochloride
MEDRTD017180Tachycardia, VentricularDISEASEci_withphenylephrine hydrochloride
MEDRTD017180Tachycardia, VentricularDISEASEci_withphenylephrine
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moaphenylephrine
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moaphenylephrine hydrochloride
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadoxylamine
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadoxylamine succinate
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 hydrobromide
MEDRTN0000181819Uncompetitive NMDA Receptor AntagonistsMOAhas_moadextromethorphan
MEDRTN0000175724Central Nervous System Activity AlterationPEhas_peacetaminophen
MEDRTN0000008371Conjunctival Arterial VasoconstrictionPEhas_pephenylephrine
MEDRTN0000008371Conjunctival Arterial VasoconstrictionPEhas_pephenylephrine hydrochloride
MEDRTN0000008657Decreased Histamine ActivityPEhas_pedoxylamine
MEDRTN0000008657Decreased Histamine ActivityPEhas_pedoxylamine succinate
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
MEDRTN0000009072Hypothalamic Endocrine Activity AlterationPEhas_peacetaminophen
MEDRTN0000175725Peripheral Nervous System Activity AlterationPEhas_peacetaminophen
MEDRTN0000000026Hepatic MetabolismPKhas_pkacetaminophen
MEDRTN0000000042Renal ExcretionPKhas_pkacetaminophen

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH650 MG / 20 MG / 12.5 MG (expressed as doxylamine succinate) / 10 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
NAMESPrescribable Synonymacetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG Powder for Oral Solution
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMultum MediSource Lexicon