FDA.reportPublic FDA data

benzocaine 7.5 MG / dextromethorphan hydrobromide 5 MG Oral Lozenge [Cepacol Sore Throat Plus Cough]

RxCUI
1039255
RxNorm name
benzocaine 7.5 MG / dextromethorphan hydrobromide 5 MG Oral Lozenge [Cepacol Sore Throat Plus Cough]
Display name
CEPACOL SORE THROAT PLUS COUGH (Oral Lozenge)
Full name
benzocaine 7.5 MG / dextromethorphan hydrobromide 5 MG Oral Lozenge [Cepacol Sore Throat Plus Cough]
Term type
SBD
Status
Active
Strength
7.5-5 mg
Dose form
Lozenge
Route
Oral Lozenge
Updated
2026-06-05 07:06:14

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
122010
Active start
122010
Multiple ingredient
YES
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
benzocaine7.5 MG / 1 EACHbenzocainebenzocaine
dextromethorphan hydrobromide5 MG / 1 EACHdextromethorphandextromethorphan hydrobromide

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Lozenge316992

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
benzocaine1399
dextromethorphan3289

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRCepacol Sore Throat Plus Cough (benzocaine 7.5 MG / dextromethorphan hydrobromide 5 MG) Oral LozengeNAMES
RxNorm Namebenzocaine 7.5 MG / dextromethorphan hydrobromide 5 MG Oral Lozenge [Cepacol Sore Throat Plus Cough]NAMES
RxNorm SynonymCepacol Sore Throat Plus Cough (benzocaine 7.5 MG / dextromethorphan hydrobromide 5 MG) Oral LozengeNAMES
TTYSBDATTRIBUTES
SPL_SET_IDc0cc32db-90f0-4106-8538-89821083ece1CODES
RxCUI1039255CODES
MMSL_CODEBD20896CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
63824-744-1663824-744Cepacol BENZOCAINE and DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLCM012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01263824-744Cepacol BENZOCAINE and DEXTROMETHORPHAN HYDROBROMIDEOTC MONOGRAPH DRUGReckitt Benckiser LLC

RxNav Current And Historical NDCs#

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

NDC11, Source, Active table
NDC11SourceActive
63824074416rxnav_ndcsyes
63824074436rxnav_ndcsyes
63824074494rxnav_ndcsyes
01150900020rxnav_historical_indirect
11509000020rxnav_historical
11509002001rxnav_historical
11509022418rxnav_historical_indirect
63824074008rxnav_historical
63824074016rxnav_historical
63824074116rxnav_historical
63824074216rxnav_historical
63824074294rxnav_historical
63824074316rxnav_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
Cepacol Extra Strength Sore Throat and CoughBENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLCc0cc32db-90f0-4106-8538-89821083ece12026-05-13WarningsExact identifier
ndc (package): 63824-744-16
ndc (product): 63824-744
ndc11 (package): 63824074416
ndc11 (package): 63824074436
ndc11 (package): 63824074494
rxcui: 1039255

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
c0cc32db-90f0-4106-8538-89821083ece1benzocaine 7.5 MG / dextromethorphan hydrobromide 5 MG Oral Lozenge [Cepacol Sore Throat Plus Cough]SBD14Cēpacol ® Extra Strength Sore Throat & Cough20260513
c0cc32db-90f0-4106-8538-89821083ece1Cepacol Sore Throat Plus Cough (benzocaine 7.5 MG / dextromethorphan hydrobromide 5 MG) Oral LozengeSY14Cēpacol ® Extra Strength Sore Throat & Cough20260513
c0cc32db-90f0-4106-8538-89821083ece1Cepacol Sore Throat Plus Cough 7.5 MG / 5 MG Oral LozengePSN14Cēpacol ® Extra Strength Sore Throat & Cough20260513

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
c0cc32db-90f0-4106-8538-89821083ece1Cēpacol ® Extra Strength Sore Throat & CoughReckitt Benckiser LLC20260513
c0cc32db-90f0-4106-8538-89821083ece1Cēpacol ® Extra Strength Sore Throat & CoughRB Health (US) LLC20260408
c0cc32db-90f0-4106-8538-89821083ece1Cēpacol ® Extra Strength Sore Throat & CoughRB Health (US) LLC20260317
d25f736d-07ee-40cf-bc16-0f2c231eecd1Cēpacol ® Extra Strength* Sore Throat mixed berryReckitt Benckiser LLC20131021
9aa7ed7c-886a-478c-acb6-688374d7fc3aNational Council for Prescription Drug Programs20120724
0cc3bca6-c5c7-4883-8e37-5d1eb1fd3b44Cēpacol ® Sore Throat & Cough LozengesReckitt Benckiser LLC20120627
66b43243-f29e-4e8c-925d-692d894de240Cēpacol ® SORE THROAT AND COUGHReckitt Benckiser LLC20111220

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCD04ABAnesthetics for topical useATC1-4benzocaine
ATCR02ADAnesthetics, localATC1-4benzocaine
ATCN01BAEsters of aminobenzoic acidATC1-4benzocaine
ATCC05ADLocal anestheticsATC1-4benzocaine
ATCR05DAOpium alkaloids and derivativesATC1-4dextromethorphan
FDASPLN0000182149Sigma-1 AgonistEPChas_epcdextromethorphan
FDASPLN0000185508Standardized Chemical AllergenEPChas_epcbenzocaine
FDASPLN0000181821Uncompetitive N-methyl-D-aspartate Receptor AntagonistEPChas_epcdextromethorphan
FDASPLN0000182147Sigma-1 Receptor AgonistsMOAhas_moadextromethorphan
FDASPLN0000181819Uncompetitive NMDA Receptor AntagonistsMOAhas_moadextromethorphan
FDASPLN0000184306Cell-mediated ImmunityPEhas_pebenzocaine
FDASPLN0000175629Increased Histamine ReleasePEhas_pebenzocaine
MEDRTD001566BenzocaineCHEMhas_ingredientbenzocaine
MEDRTD003915DextromethorphanCHEMhas_ingredientdextromethorphan
MEDRTD003915DextromethorphanCHEMhas_ingredientdextromethorphan hydrobromide
MEDRTD001424Bacterial InfectionsDISEASEci_withbenzocaine
MEDRTD002056BurnsDISEASEmay_treatbenzocaine
MEDRTD003371CoughDISEASEmay_treatdextromethorphan
MEDRTD003371CoughDISEASEmay_preventdextromethorphan
MEDRTD003371CoughDISEASEmay_treatdextromethorphan hydrobromide
MEDRTD003371CoughDISEASEmay_preventdextromethorphan hydrobromide
MEDRTD004342Drug HypersensitivityDISEASEci_withdextromethorphan hydrobromide
MEDRTD004342Drug HypersensitivityDISEASEci_withdextromethorphan
MEDRTD004342Drug HypersensitivityDISEASEci_withbenzocaine
MEDRTD004433EaracheDISEASEmay_treatbenzocaine
MEDRTD005401Fissure in AnoDISEASEmay_treatbenzocaine
MEDRTD006484HemorrhoidsDISEASEmay_treatbenzocaine
MEDRTD006561Herpes SimplexDISEASEmay_treatbenzocaine
MEDRTD019226Oral UlcerDISEASEmay_treatbenzocaine
MEDRTD010032Otitis ExternaDISEASEmay_treatbenzocaine
MEDRTD010033Otitis MediaDISEASEmay_treatbenzocaine
MEDRTD010146PainDISEASEmay_preventbenzocaine
MEDRTD011537PruritusDISEASEmay_treatbenzocaine
MEDRTD014098ToothacheDISEASEmay_treatbenzocaine
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moadextromethorphan
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moadextromethorphan hydrobromide
MEDRTN0000000109Serotonin Uptake InhibitorsMOAhas_moadextromethorphan
MEDRTN0000000109Serotonin Uptake InhibitorsMOAhas_moadextromethorphan hydrobromide
MEDRTN0000182147Sigma-1 Receptor AgonistsMOAhas_moadextromethorphan hydrobromide
MEDRTN0000182147Sigma-1 Receptor AgonistsMOAhas_moadextromethorphan
MEDRTN0000000180Sodium Channel InteractionsMOAhas_moabenzocaine
MEDRTN0000181819Uncompetitive NMDA Receptor AntagonistsMOAhas_moadextromethorphan hydrobromide
MEDRTN0000181819Uncompetitive NMDA Receptor AntagonistsMOAhas_moadextromethorphan
MEDRTN0000008701Decreased Medullary Respiratory DrivePEhas_pedextromethorphan
MEDRTN0000008701Decreased Medullary Respiratory DrivePEhas_pedextromethorphan hydrobromide
MEDRTN0000008889Decreased Sensory-Somatic Nervous System Organized Electrical ActivityPEhas_pebenzocaine

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH7.5 MG / 5 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSBD
CODESMMSL_CODEBD20896
CODESRxCUI1039255
CODESSPL_SET_IDc0cc32db-90f0-4106-8538-89821083ece1
NAMESPrescribable SynonymCepacol Sore Throat Plus Cough 7.5 MG / 5 MG Oral Lozenge
NAMESRXNAV_STRCepacol Sore Throat Plus Cough (benzocaine 7.5 MG / dextromethorphan hydrobromide 5 MG) Oral Lozenge
NAMESRxNorm Namebenzocaine 7.5 MG / dextromethorphan hydrobromide 5 MG Oral Lozenge [Cepacol Sore Throat Plus Cough]
NAMESRxNorm SynonymCepacol Sore Throat Plus Cough (benzocaine 7.5 MG / dextromethorphan hydrobromide 5 MG) Oral Lozenge
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon