FDA.reportPublic FDA data

dextromethorphan hydrobromide 3 MG/ML / guaifenesin 20 MG/ML Oral Solution

RxCUI
1234473
RxNorm name
dextromethorphan hydrobromide 3 MG/ML / guaifenesin 20 MG/ML Oral Solution
Display name
Dextromethorphan/guaiFENesin (Oral Liquid)
Full name
dextromethorphan hydrobromide 3 MG/ML / guaifenesin 20 MG/ML Oral Solution
Term type
SCD
Status
Active
Strength
15-100 mg/5ml
Dose form
Sol
Route
Oral Liquid
Updated
2026-07-17 22:19:59

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
012012
Active start
012012
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
dextromethorphan hydrobromide3 MG / 1 MLdextromethorphandextromethorphan hydrobromide
guaifenesin20 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 3 MG/ML / guaiFENesin 20 MG/ML Oral SolutionNAMES
RxNorm Namedextromethorphan hydrobromide 3 MG/ML / guaifenesin 20 MG/ML Oral SolutionNAMES
RxNorm Synonymdextromethorphan hydrobromide 15 MG / guaifenesin 100 MG per 5 ML Oral SolutionNAMES
TTYSCDATTRIBUTES
SPL_SET_ID0b638db4-5ed3-4665-abcd-f95e677adbd8CODES
SPL_SET_ID8aa32b2a-a8be-4f8d-9b1f-eb007bff8e65CODES
RxCUI1234473CODES
MMSL_CODEBD4545CODES
MMSL_CODECD4545CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
49873-302-0149873-302Stona Cough dextromethorphan hydrobromide, guaifenesinSato Pharmaceutical Co., Ltd.M012
65131-091-0865131-091BRONCOCHEM DEXTROMETHORPHAN HBr-GYAIFENESINLABORATORIO MAGNACHEM INTERNATIONAL SRLpart341

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01249873-302Stona Cough dextromethorphan hydrobromide, guaifenesinOTC MONOGRAPH DRUGSato Pharmaceutical Co., Ltd.
part34165131-091BRONCOCHEM DEXTROMETHORPHAN HBr-GYAIFENESINOTC MONOGRAPH FINALLABORATORIO MAGNACHEM INTERNATIONAL SRL

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
49873030201rxnav_ndcsyes
65131009108rxnav_ndcsyes
00005346024rxnav_historical_indirect
00005346061rxnav_historical_indirect
00031868548rxnav_historical_indirect
00047293317rxnav_historical_indirect
00047293323rxnav_historical_indirect
00106122502rxnav_historical_indirect
00121042004rxnav_historical_indirect
00121042005rxnav_historical_indirect
00121042010rxnav_historical_indirect
00182168737rxnav_historical_indirect
00182616337rxnav_historical_indirect
00223651601rxnav_historical_indirect
00223651602rxnav_historical_indirect
00223651603rxnav_historical_indirect
00364247916rxnav_historical_indirect
00364247977rxnav_historical_indirect
00364247999rxnav_historical_indirect
00372003204rxnav_historical_indirect
00372003208rxnav_historical_indirect
00436040704rxnav_historical_indirect
00436040728rxnav_historical_indirect
00552097304rxnav_historical_indirect
00556003904rxnav_historical_indirect
00556003908rxnav_historical_indirect
00556047304rxnav_historical_indirect
00556047308rxnav_historical_indirect
00686003230rxnav_historical_indirect
00686033130rxnav_historical_indirect
00814359076rxnav_historical_indirect
00814359082rxnav_historical_indirect
00814359086rxnav_historical_indirect
00839538965rxnav_historical_indirect
00839538970rxnav_historical_indirect
00839538979rxnav_historical_indirect
00879036204rxnav_historical_indirect
00879036208rxnav_historical_indirect
00879036216rxnav_historical_indirect
00879036228rxnav_historical_indirect
11383000914rxnav_historical_indirect
19458505201rxnav_historical
23558055040rxnav_historical_indirect
23558055042rxnav_historical_indirect
49158021834rxnav_historical_indirect
49158021838rxnav_historical_indirect
49158021839rxnav_historical_indirect
49738041926rxnav_historical_indirect
50383010404rxnav_historical_indirect
50383010416rxnav_historical_indirect
50383010428rxnav_historical_indirect
50732087704rxnav_historical_indirect
50732087708rxnav_historical_indirect
50732087716rxnav_historical_indirect
50732087728rxnav_historical_indirect
51079024053rxnav_historical_indirect
51432060418rxnav_historical_indirect
51432060419rxnav_historical_indirect
51432060420rxnav_historical_indirect
51432060421rxnav_historical_indirect
53073011112rxnav_historical_indirect
53076011112rxnav_historical_indirect
53076011174rxnav_historical_indirect
53113021606rxnav_historical_indirect
53978014904rxnav_historical_indirect
54092040025rxnav_historical_indirect
54838013200rxnav_historical_indirect
54838013240rxnav_historical_indirect
54838013270rxnav_historical_indirect
54838013280rxnav_historical_indirect
55505013720rxnav_historical_indirect
59741011604rxnav_historical_indirect
59741011608rxnav_historical_indirect
59741011616rxnav_historical_indirect
59741011620rxnav_historical_indirect
70242010306rxnav_historical
72483010004rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
0b638db4-5ed3-4665-abcd-f95e677adbd8dextromethorphan hydrobromide 3 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD4Stona Cough Syrup20231112
0b638db4-5ed3-4665-abcd-f95e677adbd8dextromethorphan hydrobromide 15 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY4Stona Cough Syrup20231112
0b638db4-5ed3-4665-abcd-f95e677adbd8dextromethorphan HBr 30 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN4Stona Cough Syrup20231112
3a7986cd-b16e-4201-95b1-f53b9a6c2529dextromethorphan hydrobromide 15 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY4Broncomar Maximum Cought Relief20160101
3a7986cd-b16e-4201-95b1-f53b9a6c2529dextromethorphan HBr 30 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN4Broncomar Maximum Cought Relief20160101
3a7986cd-b16e-4201-95b1-f53b9a6c2529dextromethorphan hydrobromide 3 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD4Broncomar Maximum Cought Relief20160101
8aa32b2a-a8be-4f8d-9b1f-eb007bff8e65dextromethorphan hydrobromide 3 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD3BRONCOCHEM MAXIMUM COUGH20161219
8aa32b2a-a8be-4f8d-9b1f-eb007bff8e65dextromethorphan HBr 30 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN3BRONCOCHEM MAXIMUM COUGH20161219
8aa32b2a-a8be-4f8d-9b1f-eb007bff8e65dextromethorphan hydrobromide 15 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY3BRONCOCHEM MAXIMUM COUGH20161219
afbee087-62dc-4f5d-8155-2d6c1de320eddextromethorphan HBr 30 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN120140612
afbee087-62dc-4f5d-8155-2d6c1de320eddextromethorphan hydrobromide 3 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD120140612
afbee087-62dc-4f5d-8155-2d6c1de320eddextromethorphan hydrobromide 15 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY120140612

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
0b638db4-5ed3-4665-abcd-f95e677adbd8Stona Cough SyrupSato Pharmaceutical Co., Ltd.20231112
8aa32b2a-a8be-4f8d-9b1f-eb007bff8e65BRONCOCHEM MAXIMUM COUGHLABORATORIO MAGNACHEM INTERNATIONAL SRL20161219
3a7986cd-b16e-4201-95b1-f53b9a6c2529Broncomar Maximum Cought ReliefDannso Corp./d.b.a. Essential Products | All Pharma LLC20160101
afbee087-62dc-4f5d-8155-2d6c1de320edGadal Laboratories Inc20140612

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_STRENGTH3 MG/ML / 20 MG/ML
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESTTYSCD
CODESMMSL_CODEBD4545
CODESMMSL_CODECD4545
CODESRxCUI1234473
CODESSPL_SET_ID0b638db4-5ed3-4665-abcd-f95e677adbd8
CODESSPL_SET_ID8aa32b2a-a8be-4f8d-9b1f-eb007bff8e65
CODESVUID4005457
CODESVUID4005458
CODESVUID4005469
NAMESPrescribable Synonymdextromethorphan HBr 30 MG / guaiFENesin 200 MG in 10 mL Oral Solution
NAMESRXNAV_STRdextromethorphan hydrobromide 3 MG/ML / guaiFENesin 20 MG/ML Oral Solution
NAMESRxNorm Namedextromethorphan hydrobromide 3 MG/ML / guaifenesin 20 MG/ML Oral Solution
NAMESRxNorm Synonymdextromethorphan hydrobromide 15 MG / guaifenesin 100 MG per 5 ML Oral Solution
NAMESTallman Synonymdextromethorphan hydrobromide 15 MG / guaiFENesin 100 MG per 5 ML Oral Solution
NAMESTallman Synonymdextromethorphan hydrobromide 3 MG/ML / guaiFENesin 20 MG/ML Oral Solution
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK