FDA.reportPublic FDA data

dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral Solution

RxCUI
1091331
RxNorm name
dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral Solution
Display name
Dextromethorphan/guaiFENesin/Phenylephrine (Oral Liquid)
Full name
dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral Solution
Term type
SCD
Status
Active
Strength
20-400-10 mg/5ml
Dose form
Sol
Route
Oral Liquid
Updated
2026-06-15 07:01:17

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
032011
Active start
032011
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
dextromethorphan hydrobromide4 MG / 1 MLdextromethorphandextromethorphan hydrobromide
guaifenesin80 MG / 1 MLguaifenesinguaifenesin
phenylephrine hydrochloride2 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 4 MG/ML / guaiFENesin 80 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral SolutionNAMES
RxNorm Namedextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral SolutionNAMES
RxNorm Synonymdextromethorphan hydrobromide 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 5 ML Oral SolutionNAMES
TTYSCDATTRIBUTES
SPL_SET_ID16660d82-524b-42ca-8581-48237caa13b2CODES
SPL_SET_ID6ae6a0cb-b4fc-4e7d-aefc-6a52ca1ae3d6CODES
SPL_SET_IDd169585f-b4f4-4831-8c71-e1533ae7e7c4CODES
SPL_SET_IDe966b75c-4bb4-4216-8247-baada8f5d759CODES
SPL_SET_IDfe457e6d-422d-496c-bcb9-33594f3c42ffCODES
RxCUI1091331CODES
MMSL_CODEBD27074CODES
MMSL_CODECD27074CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
45737-249-1645737-249Biocof Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine HCLAdvanced Generic CorporationM012
52083-239-0152083-239TUSICOF dextromethorphan, guaifenesin, and phenylephrineKramer NovisM012
52083-239-0452083-239TUSICOF dextromethorphan, guaifenesin, and phenylephrineKramer NovisM012
52083-239-1652083-239TUSICOF dextromethorphan, guaifenesin, and phenylephrineKramer NovisM012
52083-639-1652083-639G-TUSICOF dextromethorphan, guaifenesin, and phenylephrineKramer NovisM012
54859-517-1654859-517Tusnel Dextromethorphan HBr, Guaifenesin, Phenylephrine HClLlorens Pharmaceutical International Division, Inc.M012
63102-104-1663102-104ACTINEL DM Dextromethorphan HBr, Guaifenesin, Phenylephrine HClACTIPHARMA, LLCM012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01245737-249Biocof Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine HCLOTC MONOGRAPH DRUGAdvanced Generic Corporation

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
45737024916rxnav_ndcsyes
52083023901rxnav_ndcsyes
52083023904rxnav_ndcsyes
52083023916rxnav_ndcsyes
52083063916rxnav_ndcsyes
54859051716rxnav_ndcsyes
63102010416rxnav_ndcsyes

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
e966b75c-4bb4-4216-8247-baada8f5d759dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral SolutionSCD7TUSICOF20251112
e966b75c-4bb4-4216-8247-baada8f5d759dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 5 mL Oral SolutionPSN7TUSICOF20251112
e966b75c-4bb4-4216-8247-baada8f5d759dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 5 ML Oral SolutionSY7TUSICOF20251112
6ae6a0cb-b4fc-4e7d-aefc-6a52ca1ae3d6dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 5 ML Oral SolutionSY6AGC-Biocof 24920251230
6ae6a0cb-b4fc-4e7d-aefc-6a52ca1ae3d6dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 5 mL Oral SolutionPSN6AGC-Biocof 24920251230
6ae6a0cb-b4fc-4e7d-aefc-6a52ca1ae3d6dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral SolutionSCD6AGC-Biocof 24920251230
fe457e6d-422d-496c-bcb9-33594f3c42ffdextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral SolutionSCD6Llorens-TusnelDM 51720251229
fe457e6d-422d-496c-bcb9-33594f3c42ffdextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 5 mL Oral SolutionPSN6Llorens-TusnelDM 51720251229
fe457e6d-422d-496c-bcb9-33594f3c42ffdextromethorphan hydrobromide 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 5 ML Oral SolutionSY6Llorens-TusnelDM 51720251229
d169585f-b4f4-4831-8c71-e1533ae7e7c4dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 5 ML Oral SolutionSY5G-TUSICOF ®20251107
d169585f-b4f4-4831-8c71-e1533ae7e7c4dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 5 mL Oral SolutionPSN5G-TUSICOF ®20251107
d169585f-b4f4-4831-8c71-e1533ae7e7c4dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral SolutionSCD5G-TUSICOF ®20251107
16660d82-524b-42ca-8581-48237caa13b2dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 5 ML Oral SolutionSY2ACTINEL ® DM20240628
16660d82-524b-42ca-8581-48237caa13b2dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral SolutionSCD2ACTINEL ® DM20240628
16660d82-524b-42ca-8581-48237caa13b2dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 5 mL Oral SolutionPSN2ACTINEL ® DM20240628

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
6ae6a0cb-b4fc-4e7d-aefc-6a52ca1ae3d6AGC-Biocof 249Advanced Generic Corporation20251230
fe457e6d-422d-496c-bcb9-33594f3c42ffLlorens-TusnelDM 517Llorens Pharmaceutical International Division, Inc.20251229
e966b75c-4bb4-4216-8247-baada8f5d759TUSICOFKramer Novis20251112
d169585f-b4f4-4831-8c71-e1533ae7e7c4G-TUSICOF ®Kramer Novis20251107
16660d82-524b-42ca-8581-48237caa13b2ACTINEL ® DMACTIPHARMA, LLC20240628

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_STRENGTH4 MG/ML / 80 MG/ML / 2 MG/ML
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSCD
CODESMMSL_CODEBD27074
CODESMMSL_CODECD27074
CODESRxCUI1091331
CODESSPL_SET_ID16660d82-524b-42ca-8581-48237caa13b2
CODESSPL_SET_ID6ae6a0cb-b4fc-4e7d-aefc-6a52ca1ae3d6
CODESSPL_SET_IDd169585f-b4f4-4831-8c71-e1533ae7e7c4
CODESSPL_SET_IDe966b75c-4bb4-4216-8247-baada8f5d759
CODESSPL_SET_IDfe457e6d-422d-496c-bcb9-33594f3c42ff
CODESVUID4037939
NAMESPrescribable Synonymdextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 5 mL Oral Solution
NAMESRXNAV_STRdextromethorphan hydrobromide 4 MG/ML / guaiFENesin 80 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral Solution
NAMESRxNorm Namedextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral Solution
NAMESRxNorm Synonymdextromethorphan hydrobromide 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 5 ML Oral Solution
NAMESTallman Synonymdextromethorphan hydrobromide 20 MG / guaiFENesin 400 MG / phenylephrine hydrochloride 10 MG per 5 ML Oral Solution
NAMESTallman Synonymdextromethorphan hydrobromide 4 MG/ML / guaiFENesin 80 MG/ML / phenylephrine hydrochloride 2 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