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, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRdextromethorphan hydrobromide 3 MG/ML / guaiFENesin 20 MG/ML Oral Solution1NAMES
RxNorm Namedextromethorphan hydrobromide 3 MG/ML / guaifenesin 20 MG/ML Oral Solution1NAMES
RxNorm Synonymdextromethorphan hydrobromide 15 MG / guaifenesin 100 MG per 5 ML Oral Solution1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
2 linked values
2CODES
RxCUI12344731CODES
MMSL_CODE
2 linked values
2CODES

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#

RxNav current and historical NDC rows page 1 of 1 · 77 matching rows.

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

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stona CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINSato Pharmaceutical Co., Ltd.0b638db4-5ed3-4665-abcd-f95e677adbd82023-11-12WarningsExact identifier
ndc (package): 49873-302-01
ndc (product): 49873-302
ndc11 (package): 49873030201
rxcui: 1234473
BRONCOCHEM MAXIMUM COUGHDEXTROMETHORPHAN HBR-GYAIFENESINLABORATORIO MAGNACHEM INTERNATIONAL SRL8aa32b2a-a8be-4f8d-9b1f-eb007bff8e652016-12-19WarningsExact identifier
ndc (package): 65131-091-08
ndc (product): 65131-091
ndc11 (package): 65131009108
rxcui: 1234473

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
0b638db4-5ed3-4665-abcd-f95e677adbd8dextromethorphan HBr 30 MG / guaiFENesin 200 MG in 10 mL Oral Solution [PSN] · dextromethorphan hydrobromide 3 MG/ML / guaifenesin 20 MG/ML Oral Solution [SCD] · dextromethorphan hydrobromide 15 MG / guaifenesin 100 MG per 5 ML Oral Solution [SY]34Stona Cough Syrup20231112
3a7986cd-b16e-4201-95b1-f53b9a6c2529dextromethorphan HBr 30 MG / guaiFENesin 200 MG in 10 mL Oral Solution [PSN] · dextromethorphan hydrobromide 3 MG/ML / guaifenesin 20 MG/ML Oral Solution [SCD] · dextromethorphan hydrobromide 15 MG / guaifenesin 100 MG per 5 ML Oral Solution [SY]34Broncomar Maximum Cought Relief20160101
8aa32b2a-a8be-4f8d-9b1f-eb007bff8e65dextromethorphan HBr 30 MG / guaiFENesin 200 MG in 10 mL Oral Solution [PSN] · dextromethorphan hydrobromide 3 MG/ML / guaifenesin 20 MG/ML Oral Solution [SCD] · dextromethorphan hydrobromide 15 MG / guaifenesin 100 MG per 5 ML Oral Solution [SY]33BRONCOCHEM MAXIMUM COUGH20161219
afbee087-62dc-4f5d-8155-2d6c1de320eddextromethorphan HBr 30 MG / guaiFENesin 200 MG in 10 mL Oral Solution [PSN] · dextromethorphan hydrobromide 3 MG/ML / guaifenesin 20 MG/ML Oral Solution [SCD] · dextromethorphan hydrobromide 15 MG / guaifenesin 100 MG per 5 ML Oral Solution [SY]3120140612

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
908f70e0-706b-1234-e053-2a95a90ade84Resfridol Antitussive (OLD) (DA)Laboratorios Alfa20241212
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
26b58f9c-f138-4369-9708-09c36d88a7d6Kmart Corporation Children's Mucus Relief Cough Drug FactsKmart Corporation20151016
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
ATTRIBUTESRXNAV_HUMAN_DRUGUS
CODESVUID4005457
CODESVUID4005458
CODESVUID4005469
NAMESPrescribable Synonymdextromethorphan HBr 30 MG / guaiFENesin 200 MG in 10 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