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, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRdextromethorphan hydrobromide 4 MG/ML / guaiFENesin 80 MG/ML Oral Solution1NAMES
RxNorm Namedextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML Oral Solution1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
3 linked values
3CODES
RxCUI11133681CODES
MMSL_CODE
2 linked values
2CODES

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#

RxNav current and historical NDC rows page 1 of 1 · 6 matching rows.

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

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bio-Z-CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAdvanced Generic Corporation05e70eab-1467-4b09-991e-ef03f222e0212025-12-31WarningsExact identifier
ndc (package): 45737-251-16
ndc (product): 45737-251
ndc11 (package): 45737025116
rxcui: 1113368
G-ZYNCOFDEXTROMETHORPHAN HBR AND GUAIFENESINKramer Novisc1aa7060-0f32-4ea1-8e2e-1aa131bd55fc2025-11-14WarningsExact identifier
ndc (package): 52083-600-16
ndc (product): 52083-600
ndc11 (package): 52083060016
rxcui: 1113368
ZYNCOFDEXTROMETHORPHAN HBR AND GUAIFENESINKramer Noviscffd6d5f-0cb2-4d38-bdb0-6a21120418cc2025-11-13WarningsExact identifier
ndc (package): 52083-400-04
ndc (package): 52083-400-16
ndc (package): 52083-400-01
ndc (product): 52083-400
ndc11 (package): 52083040001
ndc11 (package): 52083040016
ndc11 (package): 52083040004
rxcui: 1113368

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 3 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
05e70eab-1467-4b09-991e-ef03f222e021dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 5 mL Oral Solution [PSN] · dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML Oral Solution [SCD] · dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG per 5 ML Oral Solution [SY] · dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML Syrup [SY]47AGC-BioZCough 25120251231
cffd6d5f-0cb2-4d38-bdb0-6a21120418ccdextromethorphan HBr 20 MG / guaiFENesin 400 MG in 5 mL Oral Solution [PSN] · dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML Oral Solution [SCD] · dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG per 5 ML Oral Solution [SY] · dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML Syrup [SY]46ZYNCOF20251113
c1aa7060-0f32-4ea1-8e2e-1aa131bd55fcdextromethorphan HBr 20 MG / guaiFENesin 400 MG in 5 mL Oral Solution [PSN] · dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML Oral Solution [SCD] · dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG per 5 ML Oral Solution [SY] · dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML Syrup [SY]45G-ZYNCOF20251114

Recently Linked 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
8a18e1ed-a8e6-4239-8b37-3ba545ffa298Drug FactsSeyer Pharmatec, Inc.20130607
845a08ee-89d4-4d5a-9ff6-03c1e02384b8National Council for Prescription Drug Programs20130303
edeaf9ed-dd8b-4828-abfe-35d4869c7394National Council for Prescription Drug Programs20130303
601296d5-d808-4845-a5be-af602f497ea0National Council for Prescription Drug Programs20120724

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
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESVUID4032183
NAMESPrescribable Synonymdextromethorphan HBr 20 MG / guaiFENesin 400 MG in 5 mL Oral Solution
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