FDA.reportPublic FDA data

dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML Oral Solution

RxCUI
1113368
RxNorm name
dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML Oral Solution
Display name
Dextromethorphan/guaiFENesin (Oral Liquid)
Full name
dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML Oral Solution
Term type
SCD
Status
Active
Strength
20-400 mg/5ml
Dose form
Sol
Route
Oral Liquid
Updated
2026-06-16 07:08:21

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
072011
Active start
072011
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

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 80 MG/ML Oral SolutionNAMES
RxNorm Namedextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML Oral SolutionNAMES
RxNorm Synonymdextromethorphan hydrobromide 20 MG / guaifenesin 400 MG per 5 ML Oral SolutionNAMES
RxNorm Synonymdextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML SyrupNAMES
TTYSCDATTRIBUTES
SPL_SET_ID05e70eab-1467-4b09-991e-ef03f222e021CODES
SPL_SET_IDc1aa7060-0f32-4ea1-8e2e-1aa131bd55fcCODES
SPL_SET_IDcffd6d5f-0cb2-4d38-bdb0-6a21120418ccCODES
RxCUI1113368CODES
MMSL_CODEBD27041CODES
MMSL_CODECD27041CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
45737-251-1645737-251Bio-Z-Cough Dextromethorphan Hydrobromide, GuaifenesinAdvanced Generic CorporationM012
52083-400-0152083-400ZYNCOF Dextromethorphan HBr and GuaifenesinKramer NovisM012
52083-400-0452083-400ZYNCOF Dextromethorphan HBr and GuaifenesinKramer NovisM012
52083-400-1652083-400ZYNCOF Dextromethorphan HBr and GuaifenesinKramer NovisM012
52083-600-1652083-600G-ZYNCOF Dextromethorphan HBr and GuaifenesinKramer NovisM012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01245737-251Bio-Z-Cough Dextromethorphan Hydrobromide, GuaifenesinOTC MONOGRAPH DRUGAdvanced Generic Corporation

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
45737025116rxnav_ndcsyes
52083040001rxnav_ndcsyes
52083040004rxnav_ndcsyes
52083040016rxnav_ndcsyes
52083060016rxnav_ndcsyes
11026265004rxnav_historical_indirect

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
05e70eab-1467-4b09-991e-ef03f222e021dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML SyrupSY7AGC-BioZCough 25120251231
05e70eab-1467-4b09-991e-ef03f222e021dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG per 5 ML Oral SolutionSY7AGC-BioZCough 25120251231
05e70eab-1467-4b09-991e-ef03f222e021dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML Oral SolutionSCD7AGC-BioZCough 25120251231
05e70eab-1467-4b09-991e-ef03f222e021dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 5 mL Oral SolutionPSN7AGC-BioZCough 25120251231
cffd6d5f-0cb2-4d38-bdb0-6a21120418ccdextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML SyrupSY6ZYNCOF20251113
cffd6d5f-0cb2-4d38-bdb0-6a21120418ccdextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML Oral SolutionSCD6ZYNCOF20251113
cffd6d5f-0cb2-4d38-bdb0-6a21120418ccdextromethorphan HBr 20 MG / guaiFENesin 400 MG in 5 mL Oral SolutionPSN6ZYNCOF20251113
cffd6d5f-0cb2-4d38-bdb0-6a21120418ccdextromethorphan hydrobromide 20 MG / guaifenesin 400 MG per 5 ML Oral SolutionSY6ZYNCOF20251113
c1aa7060-0f32-4ea1-8e2e-1aa131bd55fcdextromethorphan hydrobromide 20 MG / guaifenesin 400 MG per 5 ML Oral SolutionSY5G-ZYNCOF20251114
c1aa7060-0f32-4ea1-8e2e-1aa131bd55fcdextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML SyrupSY5G-ZYNCOF20251114
c1aa7060-0f32-4ea1-8e2e-1aa131bd55fcdextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML Oral SolutionSCD5G-ZYNCOF20251114
c1aa7060-0f32-4ea1-8e2e-1aa131bd55fcdextromethorphan HBr 20 MG / guaiFENesin 400 MG in 5 mL Oral SolutionPSN5G-ZYNCOF20251114

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
05e70eab-1467-4b09-991e-ef03f222e021AGC-BioZCough 251Advanced Generic Corporation20251231
c1aa7060-0f32-4ea1-8e2e-1aa131bd55fcG-ZYNCOFKramer Novis20251114
cffd6d5f-0cb2-4d38-bdb0-6a21120418ccZYNCOFKramer Novis20251113

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 / 80 MG/ML
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSCD
CODESMMSL_CODEBD27041
CODESMMSL_CODECD27041
CODESRxCUI1113368
CODESSPL_SET_ID05e70eab-1467-4b09-991e-ef03f222e021
CODESSPL_SET_IDc1aa7060-0f32-4ea1-8e2e-1aa131bd55fc
CODESSPL_SET_IDcffd6d5f-0cb2-4d38-bdb0-6a21120418cc
CODESVUID4032183
NAMESPrescribable Synonymdextromethorphan HBr 20 MG / guaiFENesin 400 MG in 5 mL Oral Solution
NAMESRXNAV_STRdextromethorphan hydrobromide 4 MG/ML / guaiFENesin 80 MG/ML Oral Solution
NAMESRxNorm Namedextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML Oral Solution
NAMESRxNorm Synonymdextromethorphan hydrobromide 20 MG / guaifenesin 400 MG per 5 ML Oral Solution
NAMESRxNorm Synonymdextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML Syrup
NAMESTallman Synonymdextromethorphan hydrobromide 20 MG / guaiFENesin 400 MG per 5 ML Oral Solution
NAMESTallman Synonymdextromethorphan hydrobromide 4 MG/ML / guaiFENesin 80 MG/ML Oral Solution
NAMESTallman Synonymdextromethorphan hydrobromide 4 MG/ML / guaiFENesin 80 MG/ML Syrup
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