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, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRdextromethorphan hydrobromide 1 MG/ML / guaiFENesin 10 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution1NAMES
RxNorm Namedextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
4 linked values
4CODES
RxCUI13702051CODES
MMSL_CODE
2 linked values
2CODES

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#

RxNav current and historical NDC rows page 1 of 1 · 10 matching rows.

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

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucosan Childrens Multi-Symptom GrapeDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEMenper Distributors, Inc.266c8cce-cdf9-557d-e063-6394a90a9bc32026-01-08WarningsExact identifier
ndc (package): 53145-691-04
ndc (product): 53145-691
ndc11 (package): 53145069104
rxcui: 1370205
Tukol Children Cough and CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USA235a6d2b-7302-410c-be35-4d5ff7bbdfce2024-10-11WarningsExact identifier
ndc (package): 50066-308-04
ndc (product): 50066-308
ndc11 (package): 50066030804
rxcui: 1370205
Childrens Robitussin Cough and Cold CFDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLCfcd0a8e0-ac2a-039a-be3c-534195d6bcfd2024-03-17WarningsExact identifier
ndc (package): 0031-8716-12
ndc (product): 0031-8716
ndc11 (package): 00031871612
rxcui: 1370205
Tukol ADEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USA, Inc.651f0d7c-c76b-434d-95fd-427609b40b462017-12-28WarningsExact identifier
ndc (package): 50066-536-24
ndc (product): 50066-536
ndc11 (package): 50066053624
rxcui: 1370205

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 4 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
fcd0a8e0-ac2a-039a-be3c-534195d6bcfddextromethorphan HBr 5 MG / guaiFENesin 50 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution [PSN] · dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution [SCD] · dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution [SY] · dextromethorphan hydrobromide 5 MG / guaifenesin 50 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral Solution [SY]411Drug Facts20240317
235a6d2b-7302-410c-be35-4d5ff7bbdfcedextromethorphan HBr 5 MG / guaiFENesin 50 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution [PSN] · dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution [SCD] · dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution [SY] · dextromethorphan hydrobromide 5 MG / guaifenesin 50 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral Solution [SY]46Tukol ® 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 Solution [PSN] · dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution [SCD] · dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution [SY] · dextromethorphan hydrobromide 5 MG / guaifenesin 50 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral Solution [SY]4420171228
266c8cce-cdf9-557d-e063-6394a90a9bc3dextromethorphan HBr 5 MG / guaiFENesin 50 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution [PSN] · dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution [SCD] · dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution [SY] · dextromethorphan hydrobromide 5 MG / guaifenesin 50 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral Solution [SY]42Mucosan Childrens Multi-Symptom Grape20260108

Recently Linked 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
0c6b81e4-d951-4e09-ab72-f1e7668b9a92Children's Cough & Cold CFAptaPharma Inc.20210616
200600cd-f570-4b5e-99fd-e9026b7501c5Drug FactsCVS Pharmacy, Inc. | Aurohealth LLC20201127
0151bdb7-14ff-4e10-b7a6-1cd1241393b3Drug FactsAurohealth LLC20201113
651f0d7c-c76b-434d-95fd-427609b40b46Genomma Lab USA, Inc. | AptaPharma Inc.20171228
9013f2a7-98f7-4ea4-8376-e274dde56d26National Council for Prescription Drug Programs20120724

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
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
NAMESPrescribable Synonymdextromethorphan HBr 5 MG / guaiFENesin 50 MG / phenylephrine HCl 2.5 MG in 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