FDA.reportPublic FDA data

dextromethorphan hydrobromide 4 MG/ML / guaifenesin 60 MG/ML Oral Solution

RxCUI
1117394
RxNorm name
dextromethorphan hydrobromide 4 MG/ML / guaifenesin 60 MG/ML Oral Solution
Display name
Dextromethorphan/guaiFENesin (Oral Liquid)
Full name
dextromethorphan hydrobromide 4 MG/ML / guaifenesin 60 MG/ML Oral Solution
Term type
SCD
Status
Active
Strength
20-300 mg/5ml
Dose form
Sol
Route
Oral Liquid
Updated
2026-06-16 07:09:57

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
092011
Active start
092011
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
dextromethorphan hydrobromide4 MG / 1 MLdextromethorphandextromethorphan hydrobromide
guaifenesin60 MG / 1 MLguaifenesinguaifenesin

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Solution316968

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
dextromethorphan3289
guaifenesin5032

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRdextromethorphan hydrobromide 4 MG/ML / guaiFENesin 60 MG/ML Oral SolutionNAMES
RxNorm Namedextromethorphan hydrobromide 4 MG/ML / guaifenesin 60 MG/ML Oral SolutionNAMES
RxNorm Synonymdextromethorphan hydrobromide 20 MG / guaifenesin 300 MG per 5 ML Oral SolutionNAMES
TTYSCDATTRIBUTES
SPL_SET_ID067210f8-03bc-415c-9ec5-cdad04bfb07dCODES
SPL_SET_ID826c2f47-00a6-4060-a7ad-1ef26ccfddd1CODES
SPL_SET_IDb109249a-a0be-41bd-b6ce-ef621b588ddcCODES
RxCUI1117394CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
69729-020-0469729-020DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESINOPMX LLCM012
69729-040-0469729-040DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESINOPMX LLCM012
69729-062-0469729-062DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESINOPMX LLCM012
85722-0002-485722-0002DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESINKJD Pharma Private LimitedM012
85722-0002-685722-0002DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESINKJD Pharma Private LimitedM012
85722-0002-885722-0002DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESINKJD Pharma Private LimitedM012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01269729-020DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESINOTC MONOGRAPH DRUGOPMX LLC

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
11383023604rxnav_ndcsyes
11383023608rxnav_ndcsyes
37205061001rxnav_ndcsyes
37205061026rxnav_ndcsyes
69729002004rxnav_ndcsyes
69729004004rxnav_ndcsyes
69729006204rxnav_ndcsyes
85722000204rxnav_ndcsyes
85722000206rxnav_ndcsyes
85722000208rxnav_ndcsyes
10956067401rxnav_historical
10956067404rxnav_historical
10956067408rxnav_historical
10956078604rxnav_historical
10956078608rxnav_historical
10956081904rxnav_historical
49614031726rxnav_historical
61715007704rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
826c2f47-00a6-4060-a7ad-1ef26ccfddd1dextromethorphan hydrobromide 20 MG / guaifenesin 300 MG per 5 ML Oral SolutionSY7Histiacil NF Pentrexicilina NF Brosolvan20250515
826c2f47-00a6-4060-a7ad-1ef26ccfddd1dextromethorphan hydrobromide 4 MG/ML / guaifenesin 60 MG/ML Oral SolutionSCD7Histiacil NF Pentrexicilina NF Brosolvan20250515
826c2f47-00a6-4060-a7ad-1ef26ccfddd1dextromethorphan HBr 20 MG / guaiFENesin 300 MG in 5 mL Oral SolutionPSN7Histiacil NF Pentrexicilina NF Brosolvan20250515
b109249a-a0be-41bd-b6ce-ef621b588ddcdextromethorphan hydrobromide 4 MG/ML / guaifenesin 60 MG/ML Oral SolutionSCD2Cough & Chest CongestionDextromethorphan Hbr - Guaifenesin ADULT Syrup 118 mL, 236 mL and 473 mL and measuring cup20250702
b109249a-a0be-41bd-b6ce-ef621b588ddcdextromethorphan hydrobromide 20 MG / guaifenesin 300 MG per 5 ML Oral SolutionSY2Cough & Chest CongestionDextromethorphan Hbr - Guaifenesin ADULT Syrup 118 mL, 236 mL and 473 mL and measuring cup20250702
b109249a-a0be-41bd-b6ce-ef621b588ddcdextromethorphan HBr 20 MG / guaiFENesin 300 MG in 5 mL Oral SolutionPSN2Cough & Chest CongestionDextromethorphan Hbr - Guaifenesin ADULT Syrup 118 mL, 236 mL and 473 mL and measuring cup20250702
067210f8-03bc-415c-9ec5-cdad04bfb07ddextromethorphan hydrobromide 20 MG / guaifenesin 300 MG per 5 ML Oral SolutionSY1DRUG FACTS20110126
067210f8-03bc-415c-9ec5-cdad04bfb07ddextromethorphan HBr 20 MG / guaiFENesin 300 MG in 5 mL Oral SolutionPSN1DRUG FACTS20110126
067210f8-03bc-415c-9ec5-cdad04bfb07ddextromethorphan hydrobromide 4 MG/ML / guaifenesin 60 MG/ML Oral SolutionSCD1DRUG FACTS20110126

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
b109249a-a0be-41bd-b6ce-ef621b588ddcCough & Chest CongestionDextromethorphan Hbr - Guaifenesin ADULT Syrup 118 mL, 236 mL and 473 mL and measuring cupKJD Pharma Private Limited20250702
826c2f47-00a6-4060-a7ad-1ef26ccfddd1Histiacil NF Pentrexicilina NF BrosolvanOPMX LLC | KJD Pharma Pvt Ltd20250515
067210f8-03bc-415c-9ec5-cdad04bfb07dDRUG FACTSReese Pharmaceutical Co20110126

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCR05CAExpectorantsATC1-4guaifenesin
ATCR05DAOpium alkaloids and derivativesATC1-4dextromethorphan
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 hydrobromide
MEDRTD003915DextromethorphanCHEMhas_ingredientdextromethorphan
MEDRTD006140GuaifenesinCHEMhas_ingredientguaifenesin
MEDRTD001991BronchitisDISEASEmay_treatguaifenesin
MEDRTD003139Common ColdDISEASEmay_treatguaifenesin
MEDRTD003371CoughDISEASEmay_preventdextromethorphan
MEDRTD003371CoughDISEASEmay_treatguaifenesin
MEDRTD003371CoughDISEASEmay_treatdextromethorphan hydrobromide
MEDRTD003371CoughDISEASEmay_preventdextromethorphan hydrobromide
MEDRTD003371CoughDISEASEmay_treatdextromethorphan
MEDRTD004342Drug HypersensitivityDISEASEci_withdextromethorphan hydrobromide
MEDRTD004342Drug HypersensitivityDISEASEci_withdextromethorphan
MEDRTD004342Drug HypersensitivityDISEASEci_withguaifenesin
MEDRTD007827LaryngitisDISEASEmay_treatguaifenesin
MEDRTD010612PharyngitisDISEASEmay_treatguaifenesin
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatguaifenesin
MEDRTD012852SinusitisDISEASEmay_treatguaifenesin
MEDRTD014917Whooping CoughDISEASEmay_treatguaifenesin
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
MEDRTN0000008701Decreased Medullary Respiratory DrivePEhas_pedextromethorphan
MEDRTN0000008701Decreased Medullary Respiratory DrivePEhas_pedextromethorphan hydrobromide
MEDRTN0000008867Decreased Respiratory Secretion ViscosityPEhas_peguaifenesin
MEDRTN0000009560Increased Respiratory SecretionsPEhas_peguaifenesin

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH4 MG/ML / 60 MG/ML
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESTTYSCD
CODESRxCUI1117394
CODESSPL_SET_ID067210f8-03bc-415c-9ec5-cdad04bfb07d
CODESSPL_SET_ID826c2f47-00a6-4060-a7ad-1ef26ccfddd1
CODESSPL_SET_IDb109249a-a0be-41bd-b6ce-ef621b588ddc
NAMESPrescribable Synonymdextromethorphan HBr 20 MG / guaiFENesin 300 MG in 5 mL Oral Solution
NAMESRXNAV_STRdextromethorphan hydrobromide 4 MG/ML / guaiFENesin 60 MG/ML Oral Solution
NAMESRxNorm Namedextromethorphan hydrobromide 4 MG/ML / guaifenesin 60 MG/ML Oral Solution
NAMESRxNorm Synonymdextromethorphan hydrobromide 20 MG / guaifenesin 300 MG per 5 ML Oral Solution
NAMESTallman Synonymdextromethorphan hydrobromide 20 MG / guaiFENesin 300 MG per 5 ML Oral Solution
NAMESTallman Synonymdextromethorphan hydrobromide 4 MG/ML / guaiFENesin 60 MG/ML Oral Solution
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceNational Drug Data File Plus Source Vocabulary