FDA.reportPublic FDA data

dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Suspension

RxCUI
1605844
RxNorm name
dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Suspension
Display name
Dextromethorphan/guaiFENesin (Oral Liquid)
Full name
dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Suspension
Term type
SCD
Status
Active
Strength
10-100 mg/5ml
Dose form
Susp
Route
Oral Liquid
Updated
2026-10-15 15:45:37

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
042015
Active start
042015
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
dextromethorphan hydrobromide2 MG / 1 MLdextromethorphandextromethorphan hydrobromide
guaifenesin20 MG / 1 MLguaifenesinguaifenesin

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Suspension316969

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
dextromethorphan3289
guaifenesin5032

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRdextromethorphan hydrobromide 2 MG/ML / guaiFENesin 20 MG/ML Oral Suspension1NAMES
RxNorm Namedextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Suspension1NAMES
RxNorm Synonymdextromethorphan HBr 20 MG / guaifenesin 200 MG per 10 ML Oral Suspension1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
2 linked values
2CODES
RxCUI16058441CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
49580-0385-249580-0385Tussin DM Cough and Chest Congestion Dextromethorphan HBr, GuaifenesinP & L Development, LLCM012
49580-0385-449580-0385Tussin DM Cough and Chest Congestion Dextromethorphan HBr, GuaifenesinP & L Development, LLCM012
49580-0385-849580-0385Tussin DM Cough and Chest Congestion Dextromethorphan HBr, GuaifenesinP & L Development, LLCM012
63941-385-0463941-385Tussin Cough and Chest Congestion DM Dextromethorphan HBr, GuaifenesinBest Choice (Valu Merchandisers Company)M012
63941-385-0863941-385Tussin Cough and Chest Congestion DM Dextromethorphan HBr, GuaifenesinBest Choice (Valu Merchandisers Company)M012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01249580-0385Tussin DM Cough and Chest Congestion Dextromethorphan HBr, GuaifenesinOTC MONOGRAPH DRUGP & L Development, LLC

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 13 matching rows.

NDC11, Source, Active table
NDC11SourceActive
15127080604rxnav_ndcsyes
49580038502rxnav_ndcsyes
49580038504rxnav_ndcsyes
49580038508rxnav_ndcsyes
63941038504rxnav_ndcsyes
63941038508rxnav_ndcsyes
15127008504rxnav_historical
15127008508rxnav_historical
41520038504rxnav_historical
55301038508rxnav_historical
55312038508rxnav_historical
55319038508rxnav_historical
68391079934rxnav_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
Tussin DM Cough and Chest Congestion AdultDEXTROMETHORPHAN HBR, GUAIFENESINP & L Development, LLC4af67ba7-8892-442c-b9fb-80aba9140e052025-10-28WarningsExact identifier
ndc (package): 49580-0385-4
ndc (package): 49580-0385-8
ndc (package): 49580-0385-2
ndc (product): 49580-0385
ndc11 (package): 49580038502
ndc11 (package): 49580038504
ndc11 (package): 49580038508
rxcui: 1605844
Tussin Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINBest Choice (Valu Merchandisers Company)0f2d371d-f890-41e5-ac11-db5559d324662024-02-02WarningsExact identifier
ndc (package): 63941-385-08
ndc (package): 63941-385-04
ndc (product): 63941-385
ndc11 (package): 63941038504
ndc11 (package): 63941038508
rxcui: 1605844

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
4af67ba7-8892-442c-b9fb-80aba9140e05dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Suspension [PSN] · dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Suspension [SCD] · dextromethorphan HBr 20 MG / guaifenesin 200 MG per 10 ML Oral Suspension [SY]314Drug Facts20251028
0f2d371d-f890-41e5-ac11-db5559d32466dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Suspension [PSN] · dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Suspension [SCD] · dextromethorphan HBr 20 MG / guaifenesin 200 MG per 10 ML Oral Suspension [SY]37Drug Facts20240202

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
4af67ba7-8892-442c-b9fb-80aba9140e05Drug FactsP & L Development, LLC20251028
4af67ba7-8892-442c-b9fb-80aba9140e05Drug FactsP & L Development, LLC20250530
382efbca-0a45-4ece-b43d-6948dc7c4b4dDrug FactsAAFES/Your Military Exchanges20250508
0f2d371d-f890-41e5-ac11-db5559d32466Drug FactsBest Choice (Valu Merchandisers Company)20240202
691f5813-10bb-461c-b565-d6564dc9820dDrug FactsFamily Dollar (FAMILY WELLNESS)20230130
51c2fcdb-ab31-4777-95e2-790d2b38fedfDrug FactsCare One (American Sales Company)20191030
1d539e9b-c30e-44f4-a579-7ee10976ee12Drug FactsSelect Brand Dist.20191018
b464a54b-b4e1-4310-bd75-49f73c3a58a9Drug FactsSelect Brand Dist.20190415
4ba63581-bfa3-4879-8268-3ae9c85818caDrug FactsWestern Family Foods, Inc.20181228
9f3a5835-6e6f-4e6b-8419-ba3ecb109439BJWC TUSSIN Drug FactsBJWC20160804

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 / 20 MG/ML
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESVUID4005468
NAMESPrescribable Synonymdextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Suspension
NAMESTallman Synonymdextromethorphan HBr 20 MG / guaiFENesin 200 MG per 10 ML Oral Suspension
NAMESTallman Synonymdextromethorphan hydrobromide 2 MG/ML / guaiFENesin 20 MG/ML Oral Suspension
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceVeterans Health Administration National Drug File