FDA.reportPublic FDA data

dextromethorphan hydrobromide 20 MG / guaifenesin 380 MG / pseudoephedrine hydrochloride 60 MG Oral Tablet

RxCUI
1427998
RxNorm name
dextromethorphan hydrobromide 20 MG / guaifenesin 380 MG / pseudoephedrine hydrochloride 60 MG Oral Tablet
Display name
Dextromethorphan/guaiFENesin/Pseudoephedrine (Oral Pill)
Full name
dextromethorphan hydrobromide 20 MG / guaifenesin 380 MG / pseudoephedrine hydrochloride 60 MG Oral Tablet
Term type
SCD
Status
Active
Strength
20-380-60 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-08-02 18:46:06

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
082013
Active start
082013
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
dextromethorphan hydrobromide20 MG / 1 EACHdextromethorphandextromethorphan hydrobromide
guaifenesin380 MG / 1 EACHguaifenesinguaifenesin
pseudoephedrine hydrochloride60 MG / 1 EACHpseudoephedrinepseudoephedrine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Tablet317541

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
dextromethorphan3289
guaifenesin5032
pseudoephedrine8896

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRdextromethorphan hydrobromide 20 MG / guaiFENesin 380 MG / pseudoephedrine hydrochloride 60 MG Oral TabletNAMES
RxNorm Namedextromethorphan hydrobromide 20 MG / guaifenesin 380 MG / pseudoephedrine hydrochloride 60 MG Oral TabletNAMES
TTYSCDATTRIBUTES
SPL_SET_ID739329ae-0b62-4eab-a07d-867b5d3d61e0CODES
RxCUI1427998CODES
MMSL_CODEBD28742CODES
MMSL_CODECD28742CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
50991-214-0150991-214Poly-Vent DM Dextromethorphan HBr, Guaifenesin and Pseudoephedrine HClPoly Pharmaceuticals, Inc.M012
50991-214-0250991-214Poly-Vent DM Dextromethorphan HBr, Guaifenesin and Pseudoephedrine HClPoly Pharmaceuticals, Inc.M012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01250991-214Poly-Vent DM Dextromethorphan HBr, Guaifenesin and Pseudoephedrine HClOTC MONOGRAPH DRUGPoly Pharmaceuticals, Inc.

RxNav Current And Historical NDCs#

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

NDC11, Source, Active table
NDC11SourceActive
50991021401rxnav_ndcsyes
50991021402rxnav_ndcsyes

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
Poly-Vent DMDEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCLPoly Pharmaceuticals, Inc.739329ae-0b62-4eab-a07d-867b5d3d61e02025-12-19WarningsExact identifier
ndc (package): 50991-214-01
ndc (package): 50991-214-02
ndc (product): 50991-214
ndc11 (package): 50991021402
ndc11 (package): 50991021401
rxcui: 1427998

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
739329ae-0b62-4eab-a07d-867b5d3d61e0dextromethorphan hydrobromide 20 MG / guaifenesin 380 MG / pseudoephedrine hydrochloride 60 MG Oral TabletSCD12Poly-Vent DM Tablets20251219
739329ae-0b62-4eab-a07d-867b5d3d61e0dextromethorphan HBr 20 MG / guaiFENesin 380 MG / pseudoephedrine HCl 60 MG Oral TabletPSN12Poly-Vent DM Tablets20251219

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
739329ae-0b62-4eab-a07d-867b5d3d61e0Poly-Vent DM TabletsPoly Pharmaceuticals, Inc.20251219

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCR05CAExpectorantsATC1-4guaifenesin
ATCR05DAOpium alkaloids and derivativesATC1-4dextromethorphan
ATCR01BASympathomimeticsATC1-4pseudoephedrine
FDASPLN0000175552alpha-Adrenergic AgonistEPChas_epcpseudoephedrine
FDASPLN0000193956ExpectorantEPChas_epcguaifenesin
FDASPLN0000182149Sigma-1 AgonistEPChas_epcdextromethorphan
FDASPLN0000181821Uncompetitive N-methyl-D-aspartate Receptor AntagonistEPChas_epcdextromethorphan
FDASPLN0000182147Sigma-1 Receptor AgonistsMOAhas_moadextromethorphan
FDASPLN0000181819Uncompetitive NMDA Receptor AntagonistsMOAhas_moadextromethorphan
MEDRTD003915DextromethorphanCHEMhas_ingredientdextromethorphan
MEDRTD003915DextromethorphanCHEMhas_ingredientdextromethorphan hydrobromide
MEDRTD006140GuaifenesinCHEMhas_ingredientguaifenesin
MEDRTD054199PseudoephedrineCHEMhas_ingredientpseudoephedrine hydrochloride
MEDRTD054199PseudoephedrineCHEMhas_ingredientpseudoephedrine
MEDRTD001249AsthmaDISEASEmay_treatpseudoephedrine
MEDRTD001249AsthmaDISEASEmay_treatpseudoephedrine hydrochloride
MEDRTD001991BronchitisDISEASEmay_treatguaifenesin
MEDRTD003139Common ColdDISEASEmay_treatpseudoephedrine
MEDRTD003139Common ColdDISEASEmay_treatguaifenesin
MEDRTD003139Common ColdDISEASEmay_treatpseudoephedrine hydrochloride
MEDRTD003371CoughDISEASEmay_treatguaifenesin
MEDRTD003371CoughDISEASEmay_preventdextromethorphan hydrobromide
MEDRTD003371CoughDISEASEmay_treatdextromethorphan hydrobromide
MEDRTD003371CoughDISEASEmay_treatdextromethorphan
MEDRTD003371CoughDISEASEmay_preventdextromethorphan
MEDRTD004342Drug HypersensitivityDISEASEci_withpseudoephedrine
MEDRTD004342Drug HypersensitivityDISEASEci_withdextromethorphan
MEDRTD004342Drug HypersensitivityDISEASEci_withguaifenesin
MEDRTD004342Drug HypersensitivityDISEASEci_withpseudoephedrine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withdextromethorphan hydrobromide
MEDRTD007827LaryngitisDISEASEmay_treatguaifenesin
MEDRTD010612PharyngitisDISEASEmay_treatguaifenesin
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatpseudoephedrine
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatpseudoephedrine hydrochloride
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatguaifenesin
MEDRTD012852SinusitisDISEASEmay_treatpseudoephedrine hydrochloride
MEDRTD012852SinusitisDISEASEmay_treatguaifenesin
MEDRTD012852SinusitisDISEASEmay_treatpseudoephedrine
MEDRTD014917Whooping CoughDISEASEmay_treatguaifenesin
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moapseudoephedrine hydrochloride
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moapseudoephedrine
MEDRTN0000000245Adrenergic beta-AgonistsMOAhas_moapseudoephedrine
MEDRTN0000000245Adrenergic beta-AgonistsMOAhas_moapseudoephedrine hydrochloride
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moapseudoephedrine hydrochloride
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moapseudoephedrine
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moadextromethorphan
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moadextromethorphan hydrobromide
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
MEDRTN0000181819Uncompetitive NMDA Receptor AntagonistsMOAhas_moadextromethorphan hydrobromide
MEDRTN0000008322BronchodilationPEhas_pepseudoephedrine
MEDRTN0000008322BronchodilationPEhas_pepseudoephedrine hydrochloride
MEDRTN0000008701Decreased Medullary Respiratory DrivePEhas_pedextromethorphan hydrobromide
MEDRTN0000008701Decreased Medullary Respiratory DrivePEhas_pedextromethorphan
MEDRTN0000008867Decreased Respiratory Secretion ViscosityPEhas_peguaifenesin
MEDRTN0000009560Increased Respiratory SecretionsPEhas_peguaifenesin
MEDRTN0000009908VasoconstrictionPEhas_pepseudoephedrine
MEDRTN0000009908VasoconstrictionPEhas_pepseudoephedrine hydrochloride

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH20 MG / 380 MG / 60 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSCD
CODESMMSL_CODEBD28742
CODESMMSL_CODECD28742
CODESRxCUI1427998
CODESSPL_SET_ID739329ae-0b62-4eab-a07d-867b5d3d61e0
NAMESPrescribable Synonymdextromethorphan HBr 20 MG / guaiFENesin 380 MG / pseudoephedrine HCl 60 MG Oral Tablet
NAMESRXNAV_STRdextromethorphan hydrobromide 20 MG / guaiFENesin 380 MG / pseudoephedrine hydrochloride 60 MG Oral Tablet
NAMESRxNorm Namedextromethorphan hydrobromide 20 MG / guaifenesin 380 MG / pseudoephedrine hydrochloride 60 MG Oral Tablet
NAMESTallman Synonymdextromethorphan hydrobromide 20 MG / guaiFENesin 380 MG / pseudoephedrine hydrochloride 60 MG Oral Tablet
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary