FDA.reportPublic FDA data

dextromethorphan hydrobromide 2 MG/ML / guaifenesin 37.4 MG/ML Oral Solution

RxCUI
1441364
RxNorm name
dextromethorphan hydrobromide 2 MG/ML / guaifenesin 37.4 MG/ML Oral Solution
Display name
Dextromethorphan/guaiFENesin (Oral Liquid)
Full name
dextromethorphan hydrobromide 2 MG/ML / guaifenesin 37.4 MG/ML Oral Solution
Term type
SCD
Status
Active
Strength
10-187 mg/5ml
Dose form
Sol
Route
Oral Liquid
Updated
2026-08-10 06:57:10

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
112013
Active start
112013
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
dextromethorphan hydrobromide2 MG / 1 MLdextromethorphandextromethorphan hydrobromide
guaifenesin37.4 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 2 MG/ML / guaiFENesin 37.4 MG/ML Oral SolutionNAMES
RxNorm Namedextromethorphan hydrobromide 2 MG/ML / guaifenesin 37.4 MG/ML Oral SolutionNAMES
RxNorm Synonymdextromethorphan hydrobromide 10 MG / guaifenesin 187 MG per 5 ML Oral SolutionNAMES
TTYSCDATTRIBUTES
SPL_SET_IDa627824c-5e3d-4672-a047-6c801b50b432CODES
RxCUI1441364CODES
MMSL_CODEBD30295CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
52083-630-1652083-630PECGEN DMX Dextromethorphan HBr, GuaifenesinKRAMER NOVISM012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01252083-630PECGEN DMX Dextromethorphan HBr, GuaifenesinOTC MONOGRAPH DRUGKRAMER NOVIS

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 4 matching rows.

NDC11, Source, Active table
NDC11SourceActive
52083063016rxnav_ndcsyes
58238022704rxnav_ndcsyes
58238022902rxnav_ndcsyes
45737026416rxnav_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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PECGEN DMXDEXTROMETHORPHAN HBR, GUAIFENESINKRAMER NOVISa627824c-5e3d-4672-a047-6c801b50b4322025-11-14WarningsExact identifier
ndc (package): 52083-630-16
ndc (product): 52083-630
ndc11 (package): 52083063016
rxcui: 1441364

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
eee53314-655c-496b-bc01-1caa70cbf2b7dextromethorphan HBr 10 MG / guaiFENesin 187 MG in 5 mL Oral SolutionPSN6TRISPEC DMX Cough Suppressant Expectorant Peach Flavor20211102
eee53314-655c-496b-bc01-1caa70cbf2b7dextromethorphan hydrobromide 10 MG / guaifenesin 187 MG per 5 ML Oral SolutionSY6TRISPEC DMX Cough Suppressant Expectorant Peach Flavor20211102
eee53314-655c-496b-bc01-1caa70cbf2b7dextromethorphan hydrobromide 2 MG/ML / guaifenesin 37.4 MG/ML Oral SolutionSCD6TRISPEC DMX Cough Suppressant Expectorant Peach Flavor20211102
a627824c-5e3d-4672-a047-6c801b50b432dextromethorphan HBr 10 MG / guaiFENesin 187 MG in 5 mL Oral SolutionPSN5PECGEN ® DMX20251114
a627824c-5e3d-4672-a047-6c801b50b432dextromethorphan hydrobromide 2 MG/ML / guaifenesin 37.4 MG/ML Oral SolutionSCD5PECGEN ® DMX20251114
a627824c-5e3d-4672-a047-6c801b50b432dextromethorphan hydrobromide 10 MG / guaifenesin 187 MG per 5 ML Oral SolutionSY5PECGEN ® DMX20251114
eb29e7cc-e6bb-4b33-88ee-aa3acd6f2970dextromethorphan hydrobromide 10 MG / guaifenesin 187 MG per 5 ML Oral SolutionSY3AGC-BiospecDMX 26420241220
eb29e7cc-e6bb-4b33-88ee-aa3acd6f2970dextromethorphan hydrobromide 2 MG/ML / guaifenesin 37.4 MG/ML Oral SolutionSCD3AGC-BiospecDMX 26420241220
eb29e7cc-e6bb-4b33-88ee-aa3acd6f2970dextromethorphan HBr 10 MG / guaiFENesin 187 MG in 5 mL Oral SolutionPSN3AGC-BiospecDMX 26420241220
95f910b0-1bab-4826-868a-a9d0148f23c2dextromethorphan HBr 10 MG / guaiFENesin 187 MG in 5 mL Oral SolutionPSN1TRISPEC DMX Pediatric Drops Cough Suppressant Expectorant CHERRY RASPBERRY Flavor20140227
95f910b0-1bab-4826-868a-a9d0148f23c2dextromethorphan hydrobromide 2 MG/ML / guaifenesin 37.4 MG/ML Oral SolutionSCD1TRISPEC DMX Pediatric Drops Cough Suppressant Expectorant CHERRY RASPBERRY Flavor20140227
95f910b0-1bab-4826-868a-a9d0148f23c2dextromethorphan hydrobromide 10 MG / guaifenesin 187 MG per 5 ML Oral SolutionSY1TRISPEC DMX Pediatric Drops Cough Suppressant Expectorant CHERRY RASPBERRY Flavor20140227

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
a627824c-5e3d-4672-a047-6c801b50b432PECGEN ® DMXKRAMER NOVIS20251114
eb29e7cc-e6bb-4b33-88ee-aa3acd6f2970AGC-BiospecDMX 264Advanced Generic Corporation20241220
eee53314-655c-496b-bc01-1caa70cbf2b7TRISPEC DMX Cough Suppressant Expectorant Peach FlavorDeliz Pharmaceutical Corp | Woodfield Pharmaceutical, LLC20211102
95f910b0-1bab-4826-868a-a9d0148f23c2TRISPEC DMX Pediatric Drops Cough Suppressant Expectorant CHERRY RASPBERRY FlavorDeliz Pharmaceutical Corp | TG United Liquid, Inc.20140227

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_STRENGTH2 MG/ML / 37.4 MG/ML
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSCD
CODESMMSL_CODEBD30295
CODESRxCUI1441364
CODESSPL_SET_IDa627824c-5e3d-4672-a047-6c801b50b432
CODESVUID4034492
NAMESPrescribable Synonymdextromethorphan HBr 10 MG / guaiFENesin 187 MG in 5 mL Oral Solution
NAMESRXNAV_STRdextromethorphan hydrobromide 2 MG/ML / guaiFENesin 37.4 MG/ML Oral Solution
NAMESRxNorm Namedextromethorphan hydrobromide 2 MG/ML / guaifenesin 37.4 MG/ML Oral Solution
NAMESRxNorm Synonymdextromethorphan hydrobromide 10 MG / guaifenesin 187 MG per 5 ML Oral Solution
NAMESTallman Synonymdextromethorphan hydrobromide 10 MG / guaiFENesin 187 MG per 5 ML Oral Solution
NAMESTallman Synonymdextromethorphan hydrobromide 2 MG/ML / guaiFENesin 37.4 MG/ML Oral Solution
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