FDA.reportPublic FDA data

dextromethorphan hydrobromide 5 MG / menthol 5 MG Oral Lozenge

RxCUI
1301246
RxNorm name
dextromethorphan hydrobromide 5 MG / menthol 5 MG Oral Lozenge
Display name
Dextromethorphan/Menthol (Oral Lozenge)
Full name
dextromethorphan hydrobromide 5 MG / menthol 5 MG Oral Lozenge
Term type
SCD
Status
Active
Strength
5-5 mg
Dose form
Lozenge
Route
Oral Lozenge
Updated
2026-07-20 06:55:32

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
082012
Active start
082012
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
dextromethorphan hydrobromide5 MG / 1 EACHdextromethorphandextromethorphan hydrobromide
menthol5 MG / 1 EACHmentholmenthol

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Lozenge316992

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
dextromethorphan3289
menthol6750

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRdextromethorphan hydrobromide 5 MG / menthol 5 MG Oral Lozenge1NAMES
RxNorm Namedextromethorphan hydrobromide 5 MG / menthol 5 MG Oral Lozenge1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
2 linked values
2CODES
RxCUI13012461CODES
MMSL_CODE
2 linked values
2CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0031-9306-010031-9306Robitussin Medi-Soothers dextromethorphan hydrobromide, mentholHaleon US Holdings LLCM012
0031-9306-020031-9306Robitussin Medi-Soothers dextromethorphan hydrobromide, mentholHaleon US Holdings LLCM012
0031-9307-010031-9307Robitussin Medi-Soothers dextromethorphan hydrobromide, mentholHaleon US Holdings LLCM012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M0120031-9306Robitussin Medi-Soothers dextromethorphan hydrobromide, mentholOTC MONOGRAPH DRUGHaleon US Holdings LLC

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 18 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00031034003rxnav_ndcsyes
00031034006rxnav_ndcsyes
00031034009rxnav_ndcsyes
00031930601rxnav_ndcsyes
00031930602rxnav_ndcsyes
00031930701rxnav_ndcsyes
00031864904rxnav_historical_indirect
00031864905rxnav_historical_indirect
00031864916rxnav_historical_indirect
36800014816rxnav_historical
36800014916rxnav_historical
52642000616rxnav_historical
52642000716rxnav_historical
59779006416rxnav_historical
63824016016rxnav_historical
63824016116rxnav_historical
63824016316rxnav_historical_indirect
63824016416rxnav_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
Robitussin Medi-SoothersDEXTROMETHORPHAN HYDROBROMIDE, MENTHOLHaleon US Holdings LLC4c3d57e3-e40b-41ca-b44b-5f4c5f4dbae52024-04-06WarningsExact identifier
ndc (package): 0031-9307-01
ndc (product): 0031-9307
ndc11 (package): 00031930701
rxcui: 1301246
Robitussin Medi-SoothersDEXTROMETHORPHAN HYDROBROMIDE, MENTHOLHaleon US Holdings LLC6bec225e-a203-4866-b0db-b76f73a6ae252024-03-19WarningsExact identifier
ndc (package): 0031-9306-02
ndc (package): 0031-9306-01
ndc (product): 0031-9306
ndc11 (package): 00031930602
ndc11 (package): 00031930601
rxcui: 1301246

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
4c3d57e3-e40b-41ca-b44b-5f4c5f4dbae5dextromethorphan HBr 5 MG / menthol 5 MG Oral Lozenge [PSN] · dextromethorphan hydrobromide 5 MG / menthol 5 MG Oral Lozenge [SCD]22Drug Facts20240406
6bec225e-a203-4866-b0db-b76f73a6ae25dextromethorphan HBr 5 MG / menthol 5 MG Oral Lozenge [PSN] · dextromethorphan hydrobromide 5 MG / menthol 5 MG Oral Lozenge [SCD]22Drug Facts20240319

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
4c3d57e3-e40b-41ca-b44b-5f4c5f4dbae5Drug FactsHaleon US Holdings LLC20240406
6bec225e-a203-4866-b0db-b76f73a6ae25Drug FactsHaleon US Holdings LLC20240319
e0ac4eb0-5bf9-42e0-a641-50ec8d6bd33cCVS Pharmacy Cough Relief Honey Lemon FlavorCVS Pharmacy, Inc. | Bestco, Inc.20200211
ba0ef46a-c066-47f8-a9d5-d7192adc6c6aDelsym ® Cough Plus™ Soothing ActionReckitt Benckiser LLC20130501
6c5b6a85-6c84-4751-9386-b35fa2901c3fNational Council for Prescription Drug Programs20130213
9c95c524-6ed9-4eef-b236-e8770ed2daceNational Council for Prescription Drug Programs20130213
bc0334df-0f75-4be9-b922-f3e0fc7289a6Delsym ® Cough Relief Plus Soothing ActionReckitt Benckiser LLC20120314
cac708a5-af6c-4c60-beb4-32e792f588c5Delsym ® Cough Relief Plus Soothing ActionReckitt Benckiser LLC20120112

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCR05DAOpium alkaloids and derivativesATC1-4dextromethorphan
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
MEDRTD008610MentholCHEMhas_ingredientmenthol
MEDRTD003371CoughDISEASEmay_preventdextromethorphan
MEDRTD003371CoughDISEASEmay_preventdextromethorphan hydrobromide
MEDRTD003371CoughDISEASEmay_treatdextromethorphan
MEDRTD003371CoughDISEASEmay_treatdextromethorphan hydrobromide
MEDRTD004342Drug HypersensitivityDISEASEci_withdextromethorphan
MEDRTD004342Drug HypersensitivityDISEASEci_withmenthol
MEDRTD004342Drug HypersensitivityDISEASEci_withdextromethorphan hydrobromide
MEDRTD010146PainDISEASEmay_treatmenthol
MEDRTD012871Skin DiseasesDISEASEmay_treatmenthol
MEDRTN0000000069Calcium Channel AntagonistsMOAhas_moamenthol
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moadextromethorphan
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moadextromethorphan hydrobromide
MEDRTN0000000109Serotonin Uptake InhibitorsMOAhas_moadextromethorphan
MEDRTN0000000109Serotonin Uptake InhibitorsMOAhas_moadextromethorphan hydrobromide
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
MEDRTN0000008889Decreased Sensory-Somatic Nervous System Organized Electrical ActivityPEhas_pementhol

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESACTIVATED06/27/2023
ATTRIBUTESAVAILABLE_STRENGTH5 MG / 5 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
NAMESPrescribable Synonymdextromethorphan HBr 5 MG / menthol 5 MG Oral Lozenge
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary