FDA.reportPublic FDA data

dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution

RxCUI
1370205
RxNorm name
dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution
Display name
Dextromethorphan/guaiFENesin/Phenylephrine (Oral Liquid)
Full name
dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution
Term type
SCD
Status
Active
Strength
5-50-2.5 mg/5ml
Dose form
Sol
Route
Oral Liquid
Updated
2026-07-26 07:00:26

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
032013
Active start
032013
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
phenylephrine hydrochloride0.5 MG / 1 MLphenylephrinephenylephrine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Solution316968

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
dextromethorphan3289
guaifenesin5032
phenylephrine8163

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRdextromethorphan hydrobromide 1 MG/ML / guaiFENesin 10 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionNAMES
RxNorm Namedextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionNAMES
RxNorm Synonymdextromethorphan hydrobromide 10 MG / guaifenesin 100 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionNAMES
RxNorm Synonymdextromethorphan hydrobromide 5 MG / guaifenesin 50 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral SolutionNAMES
TTYSCDATTRIBUTES
SPL_SET_ID235a6d2b-7302-410c-be35-4d5ff7bbdfceCODES
SPL_SET_ID266c8cce-cdf9-557d-e063-6394a90a9bc3CODES
SPL_SET_ID651f0d7c-c76b-434d-95fd-427609b40b46CODES
SPL_SET_IDfcd0a8e0-ac2a-039a-be3c-534195d6bcfdCODES
RxCUI1370205CODES
MMSL_CODEBD25528CODES
MMSL_CODECD25528CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0031-8716-120031-8716Childrens Robitussin Cough and Cold CF dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochlorideHaleon US Holdings LLCM001
50066-308-0450066-308Tukol Children Cough and Congestion Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine HydrochlorideGenomma Lab USAM012
50066-536-2450066-536Tukol A DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USA, Inc.part341
53145-691-0453145-691Mucosan Childrens Multi-Symptom Grape DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDEMenper Distributors, Inc.M012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M0010031-8716Childrens Robitussin Cough and Cold CF dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochlorideOTC MONOGRAPH DRUGHaleon US Holdings LLC
M01250066-308Tukol Children Cough and Congestion Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine HydrochlorideOTC MONOGRAPH DRUGGenomma Lab USA
part34150066-536Tukol A DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEOTC MONOGRAPH FINALGenomma Lab USA, Inc.

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
00031209149rxnav_ndcsyes
00031871612rxnav_ndcsyes
50066030804rxnav_ndcsyes
50066053624rxnav_ndcsyes
53145069104rxnav_ndcsyes
00031209125rxnav_historical
50383059702rxnav_historical_indirect
58602015424rxnav_historical
59779098424rxnav_historical
76281032524rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
fcd0a8e0-ac2a-039a-be3c-534195d6bcfddextromethorphan hydrobromide 10 MG / guaifenesin 100 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionSY11Drug Facts20240317
fcd0a8e0-ac2a-039a-be3c-534195d6bcfddextromethorphan HBr 5 MG / guaiFENesin 50 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSN11Drug Facts20240317
fcd0a8e0-ac2a-039a-be3c-534195d6bcfddextromethorphan hydrobromide 5 MG / guaifenesin 50 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral SolutionSY11Drug Facts20240317
fcd0a8e0-ac2a-039a-be3c-534195d6bcfddextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD11Drug Facts20240317
235a6d2b-7302-410c-be35-4d5ff7bbdfcedextromethorphan hydrobromide 5 MG / guaifenesin 50 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral SolutionSY6Tukol ® Children's Cough & Congestion Syrup20241011
235a6d2b-7302-410c-be35-4d5ff7bbdfcedextromethorphan hydrobromide 10 MG / guaifenesin 100 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionSY6Tukol ® Children's Cough & Congestion Syrup20241011
235a6d2b-7302-410c-be35-4d5ff7bbdfcedextromethorphan HBr 5 MG / guaiFENesin 50 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSN6Tukol ® Children's Cough & Congestion Syrup20241011
235a6d2b-7302-410c-be35-4d5ff7bbdfcedextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD6Tukol ® Children's Cough & Congestion Syrup20241011
651f0d7c-c76b-434d-95fd-427609b40b46dextromethorphan HBr 5 MG / guaiFENesin 50 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSN420171228
651f0d7c-c76b-434d-95fd-427609b40b46dextromethorphan hydrobromide 5 MG / guaifenesin 50 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral SolutionSY420171228
651f0d7c-c76b-434d-95fd-427609b40b46dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionSY420171228
651f0d7c-c76b-434d-95fd-427609b40b46dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD420171228
266c8cce-cdf9-557d-e063-6394a90a9bc3dextromethorphan HBr 5 MG / guaiFENesin 50 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSN2Mucosan Childrens Multi-Symptom Grape20260108
266c8cce-cdf9-557d-e063-6394a90a9bc3dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD2Mucosan Childrens Multi-Symptom Grape20260108
266c8cce-cdf9-557d-e063-6394a90a9bc3dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionSY2Mucosan Childrens Multi-Symptom Grape20260108
266c8cce-cdf9-557d-e063-6394a90a9bc3dextromethorphan hydrobromide 5 MG / guaifenesin 50 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral SolutionSY2Mucosan Childrens Multi-Symptom Grape20260108

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
266c8cce-cdf9-557d-e063-6394a90a9bc3Mucosan Childrens Multi-Symptom GrapeMenper Distributors, Inc.20260108
235a6d2b-7302-410c-be35-4d5ff7bbdfceTukol ® Children's Cough & Congestion SyrupGenomma Lab USA20241011
fcd0a8e0-ac2a-039a-be3c-534195d6bcfdDrug FactsHaleon US Holdings LLC20240317
651f0d7c-c76b-434d-95fd-427609b40b46Genomma Lab USA, Inc. | AptaPharma Inc.20171228

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCC01CAAdrenergic and dopaminergic agentsATC1-4phenylephrine
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
MEDRTD003915DextromethorphanCHEMhas_ingredientdextromethorphan
MEDRTD003915DextromethorphanCHEMhas_ingredientdextromethorphan hydrobromide
MEDRTD006140GuaifenesinCHEMhas_ingredientguaifenesin
MEDRTD010656PhenylephrineCHEMhas_ingredientphenylephrine hydrochloride
MEDRTD010656PhenylephrineCHEMhas_ingredientphenylephrine
MEDRTD013447SulfitesCHEMci_chemclassphenylephrine
MEDRTD013447SulfitesCHEMci_chemclassphenylephrine hydrochloride
MEDRTD001991BronchitisDISEASEmay_treatguaifenesin
MEDRTD003139Common ColdDISEASEmay_treatguaifenesin
MEDRTD003371CoughDISEASEmay_preventdextromethorphan hydrobromide
MEDRTD003371CoughDISEASEmay_treatguaifenesin
MEDRTD003371CoughDISEASEmay_treatdextromethorphan
MEDRTD003371CoughDISEASEmay_preventdextromethorphan
MEDRTD003371CoughDISEASEmay_treatdextromethorphan hydrobromide
MEDRTD004342Drug HypersensitivityDISEASEci_withphenylephrine
MEDRTD004342Drug HypersensitivityDISEASEci_withphenylephrine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withdextromethorphan hydrobromide
MEDRTD004342Drug HypersensitivityDISEASEci_withguaifenesin
MEDRTD004342Drug HypersensitivityDISEASEci_withdextromethorphan
MEDRTD005401Fissure in AnoDISEASEmay_treatphenylephrine hydrochloride
MEDRTD005401Fissure in AnoDISEASEmay_treatphenylephrine
MEDRTD005902Glaucoma, Open-AngleDISEASEmay_treatphenylephrine hydrochloride
MEDRTD005902Glaucoma, Open-AngleDISEASEmay_treatphenylephrine
MEDRTD006484HemorrhoidsDISEASEmay_treatphenylephrine hydrochloride
MEDRTD006484HemorrhoidsDISEASEmay_treatphenylephrine
MEDRTD006973HypertensionDISEASEci_withphenylephrine
MEDRTD006973HypertensionDISEASEci_withphenylephrine hydrochloride
MEDRTD007022HypotensionDISEASEmay_treatphenylephrine
MEDRTD007022HypotensionDISEASEmay_treatphenylephrine hydrochloride
MEDRTD007827LaryngitisDISEASEmay_treatguaifenesin
MEDRTD015878MydriasisDISEASEinducesphenylephrine hydrochloride
MEDRTD015878MydriasisDISEASEinducesphenylephrine
MEDRTD010612PharyngitisDISEASEmay_treatguaifenesin
MEDRTD011538Pruritus AniDISEASEmay_treatphenylephrine
MEDRTD011538Pruritus AniDISEASEmay_treatphenylephrine hydrochloride
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatguaifenesin
MEDRTD012223Rhinitis, VasomotorDISEASEmay_treatphenylephrine hydrochloride
MEDRTD012223Rhinitis, VasomotorDISEASEmay_treatphenylephrine
MEDRTD012772Shock, SepticDISEASEmay_treatphenylephrine hydrochloride
MEDRTD012772Shock, SepticDISEASEmay_treatphenylephrine
MEDRTD012852SinusitisDISEASEmay_treatguaifenesin
MEDRTD013617Tachycardia, SupraventricularDISEASEmay_treatphenylephrine
MEDRTD013617Tachycardia, SupraventricularDISEASEmay_treatphenylephrine hydrochloride
MEDRTD017180Tachycardia, VentricularDISEASEci_withphenylephrine
MEDRTD017180Tachycardia, VentricularDISEASEci_withphenylephrine hydrochloride
MEDRTD014917Whooping CoughDISEASEmay_treatguaifenesin
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moaphenylephrine hydrochloride
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moaphenylephrine
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moadextromethorphan hydrobromide
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moadextromethorphan
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
MEDRTN0000008371Conjunctival Arterial VasoconstrictionPEhas_pephenylephrine
MEDRTN0000008371Conjunctival Arterial VasoconstrictionPEhas_pephenylephrine hydrochloride
MEDRTN0000008701Decreased Medullary Respiratory DrivePEhas_pedextromethorphan hydrobromide
MEDRTN0000008701Decreased Medullary Respiratory DrivePEhas_pedextromethorphan
MEDRTN0000008896Decreased Nasal and Sinus SecretionsPEhas_pephenylephrine hydrochloride
MEDRTN0000008896Decreased Nasal and Sinus SecretionsPEhas_pephenylephrine
MEDRTN0000008867Decreased Respiratory Secretion ViscosityPEhas_peguaifenesin
MEDRTN0000009560Increased Respiratory SecretionsPEhas_peguaifenesin

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH1 MG/ML / 10 MG/ML / 0.5 MG/ML
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSCD
CODESMMSL_CODEBD25528
CODESMMSL_CODECD25528
CODESRxCUI1370205
CODESSPL_SET_ID235a6d2b-7302-410c-be35-4d5ff7bbdfce
CODESSPL_SET_ID266c8cce-cdf9-557d-e063-6394a90a9bc3
CODESSPL_SET_ID651f0d7c-c76b-434d-95fd-427609b40b46
CODESSPL_SET_IDfcd0a8e0-ac2a-039a-be3c-534195d6bcfd
NAMESPrescribable Synonymdextromethorphan HBr 5 MG / guaiFENesin 50 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution
NAMESRXNAV_STRdextromethorphan hydrobromide 1 MG/ML / guaiFENesin 10 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution
NAMESRxNorm Namedextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution
NAMESRxNorm Synonymdextromethorphan hydrobromide 10 MG / guaifenesin 100 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution
NAMESRxNorm Synonymdextromethorphan hydrobromide 5 MG / guaifenesin 50 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral Solution
NAMESTallman Synonymdextromethorphan hydrobromide 1 MG/ML / guaiFENesin 10 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution
NAMESTallman Synonymdextromethorphan hydrobromide 10 MG / guaiFENesin 100 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution
NAMESTallman Synonymdextromethorphan hydrobromide 5 MG / guaiFENesin 50 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral Solution
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary