FDA.reportPublic FDA data

dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML / pseudoephedrine hydrochloride 3 MG/ML Oral Solution

RxCUI
1098911
RxNorm name
dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML / pseudoephedrine hydrochloride 3 MG/ML Oral Solution
Display name
Dextromethorphan/guaiFENesin/Pseudoephedrine (Oral Liquid)
Full name
dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML / pseudoephedrine hydrochloride 3 MG/ML Oral Solution
Term type
SCD
Status
Active
Strength
5-50-15 mg/5ml
Dose form
Sol
Route
Oral Liquid
Updated
2026-06-15 07:02:22

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
052011
Active start
052011
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
dextromethorphan hydrobromide1 MG / 1 MLdextromethorphandextromethorphan hydrobromide
guaifenesin10 MG / 1 MLguaifenesinguaifenesin
pseudoephedrine hydrochloride3 MG / 1 MLpseudoephedrinepseudoephedrine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Solution316968

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
dextromethorphan3289
guaifenesin5032
pseudoephedrine8896

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRdextromethorphan hydrobromide 1 MG/ML / guaiFENesin 10 MG/ML / pseudoephedrine hydrochloride 3 MG/ML Oral SolutionNAMES
RxNorm Namedextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML / pseudoephedrine hydrochloride 3 MG/ML Oral SolutionNAMES
RxNorm Synonymdextromethorphan HBr 5 MG / guaifenesin 50 MG / pseudoephedrine HCl 15 MG per 5 ML Oral SolutionNAMES
TTYSCDATTRIBUTES
SPL_SET_ID6bb92d74-4893-40b8-af58-eb307155e876CODES
SPL_SET_ID82f447f6-4f1b-4f56-9d7d-ea02adeea88cCODES
RxCUI1098911CODES
MMSL_CODEBD4717CODES
MMSL_CODECD4717CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
54859-544-0454859-544Tusnel Dextromethorphan, Guiafenesin, Pseudoephedrine HClLlorens Pharmaceutical International DivisionM012
54859-544-1654859-544Tusnel Dextromethorphan, Guiafenesin, Pseudoephedrine HClLlorens Pharmaceutical International DivisionM012
63102-102-1663102-102ACTINEL PEDIATRIC Dextromethorphan HBr,Guaifenesin,Pseudoephedrine HClACTIPHARMA, LLCM012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01254859-544Tusnel Dextromethorphan, Guiafenesin, Pseudoephedrine HClOTC MONOGRAPH DRUGLlorens Pharmaceutical International Division

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
45737020716rxnav_ndcsyes
54859054404rxnav_ndcsyes
54859054416rxnav_ndcsyes
63102010216rxnav_ndcsyes
00043053714rxnav_historical_indirect
00043053718rxnav_historical_indirect
43913040616rxnav_historical
54859054410rxnav_historical
55422043216rxnav_historical_indirect
55422054404rxnav_historical_indirect

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
82f447f6-4f1b-4f56-9d7d-ea02adeea88cdextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML / pseudoephedrine hydrochloride 3 MG/ML Oral SolutionSCD9Llorens-Tusnel Ped 54420251231
82f447f6-4f1b-4f56-9d7d-ea02adeea88cdextromethorphan HBr 5 MG / guaiFENesin 50 MG / pseudoephedrine HCl 15 MG in 5 mL Oral SolutionPSN9Llorens-Tusnel Ped 54420251231
82f447f6-4f1b-4f56-9d7d-ea02adeea88cdextromethorphan HBr 5 MG / guaifenesin 50 MG / pseudoephedrine HCl 15 MG per 5 ML Oral SolutionSY9Llorens-Tusnel Ped 54420251231
271c5895-25f5-4162-a278-6629b0ad03c1dextromethorphan HBr 5 MG / guaifenesin 50 MG / pseudoephedrine HCl 15 MG per 5 ML Oral SolutionSY8AGC-BionelPed 20720241220
271c5895-25f5-4162-a278-6629b0ad03c1dextromethorphan HBr 5 MG / guaiFENesin 50 MG / pseudoephedrine HCl 15 MG in 5 mL Oral SolutionPSN8AGC-BionelPed 20720241220
271c5895-25f5-4162-a278-6629b0ad03c1dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML / pseudoephedrine hydrochloride 3 MG/ML Oral SolutionSCD8AGC-BionelPed 20720241220
6bb92d74-4893-40b8-af58-eb307155e876dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML / pseudoephedrine hydrochloride 3 MG/ML Oral SolutionSCD6ACTINEL ® Pediatric20250708
6bb92d74-4893-40b8-af58-eb307155e876dextromethorphan HBr 5 MG / guaifenesin 50 MG / pseudoephedrine HCl 15 MG per 5 ML Oral SolutionSY6ACTINEL ® Pediatric20250708
6bb92d74-4893-40b8-af58-eb307155e876dextromethorphan HBr 5 MG / guaiFENesin 50 MG / pseudoephedrine HCl 15 MG in 5 mL Oral SolutionPSN6ACTINEL ® Pediatric20250708
0c2632f4-edbc-47d4-94ef-af3512520596dextromethorphan HBr 5 MG / guaifenesin 50 MG / pseudoephedrine HCl 15 MG per 5 ML Oral SolutionSY1G-Tuss-NL Ped20140423
0c2632f4-edbc-47d4-94ef-af3512520596dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML / pseudoephedrine hydrochloride 3 MG/ML Oral SolutionSCD1G-Tuss-NL Ped20140423
0c2632f4-edbc-47d4-94ef-af3512520596dextromethorphan HBr 5 MG / guaiFENesin 50 MG / pseudoephedrine HCl 15 MG in 5 mL Oral SolutionPSN1G-Tuss-NL Ped20140423

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
82f447f6-4f1b-4f56-9d7d-ea02adeea88cLlorens-Tusnel Ped 544Llorens Pharmaceutical International Division20251231
6bb92d74-4893-40b8-af58-eb307155e876ACTINEL ® PediatricACTIPHARMA, LLC20250708
271c5895-25f5-4162-a278-6629b0ad03c1AGC-BionelPed 207Advanced Generic Corporation20241220
0c2632f4-edbc-47d4-94ef-af3512520596G-Tuss-NL PedMcLaren Medical | davAgen Pharmaceutical, LLC20140423

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_STRENGTH1 MG/ML / 10 MG/ML / 3 MG/ML
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSCD
CODESMMSL_CODEBD4717
CODESMMSL_CODECD4717
CODESRxCUI1098911
CODESSPL_SET_ID6bb92d74-4893-40b8-af58-eb307155e876
CODESSPL_SET_ID82f447f6-4f1b-4f56-9d7d-ea02adeea88c
CODESVUID4007523
NAMESPrescribable Synonymdextromethorphan HBr 5 MG / guaiFENesin 50 MG / pseudoephedrine HCl 15 MG in 5 mL Oral Solution
NAMESRXNAV_STRdextromethorphan hydrobromide 1 MG/ML / guaiFENesin 10 MG/ML / pseudoephedrine hydrochloride 3 MG/ML Oral Solution
NAMESRxNorm Namedextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML / pseudoephedrine hydrochloride 3 MG/ML Oral Solution
NAMESRxNorm Synonymdextromethorphan HBr 5 MG / guaifenesin 50 MG / pseudoephedrine HCl 15 MG per 5 ML Oral Solution
NAMESTallman Synonymdextromethorphan HBr 5 MG / guaiFENesin 50 MG / pseudoephedrine HCl 15 MG per 5 ML Oral Solution
NAMESTallman Synonymdextromethorphan hydrobromide 1 MG/ML / guaiFENesin 10 MG/ML / pseudoephedrine hydrochloride 3 MG/ML Oral Solution
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceVeterans Health Administration National Drug File