FDA.reportPublic FDA data

benzocaine 15 MG / menthol 3.6 MG Oral Lozenge [Cepacol Sore Throat Pain Relief]

RxCUI
1235477
RxNorm name
benzocaine 15 MG / menthol 3.6 MG Oral Lozenge [Cepacol Sore Throat Pain Relief]
Display name
CEPACOL SORE THROAT PAIN RELIEF (Oral Lozenge)
Full name
benzocaine 15 MG / menthol 3.6 MG Oral Lozenge [Cepacol Sore Throat Pain Relief]
Term type
SBD
Status
Active
Strength
15-3.6 mg
Dose form
Lozenge
Route
Oral Lozenge
Updated
2026-06-06 07:15:52

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
022012
Active start
022012
Multiple ingredient
YES
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
benzocaine15 MG / 1 EACHbenzocainebenzocaine
menthol3.6 MG / 1 EACHmentholmenthol

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Lozenge316992

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
benzocaine1399
menthol6750

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRCepacol Sore Throat Pain Relief 15/3.6 Oral LozengeNAMES
RxNorm Namebenzocaine 15 MG / menthol 3.6 MG Oral Lozenge [Cepacol Sore Throat Pain Relief]NAMES
RxNorm SynonymCepacol Sore Throat Pain Relief 15/3.6 (benzocaine / menthol) Oral LozengeNAMES
RxNorm SynonymCepacol Sore Throat Pain Relief 15/3.6 Oral LozengeNAMES
TTYSBDATTRIBUTES
SPL_SET_ID941e36dd-d8d0-4e5c-8585-10e8f06bf8f0CODES
RxCUI1235477CODES
MMSL_CODEBD25325CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
63824-713-1663824-713Cepacol Benzocaine and MentholReckitt Benckiser LLCM022

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M02263824-713Cepacol Benzocaine and MentholOTC MONOGRAPH DRUGReckitt Benckiser LLC

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
63824071304rxnav_ndcsyes
63824071316rxnav_ndcsyes
63824071394rxnav_ndcsyes
63824071516rxnav_ndcsyes
63824072282rxnav_ndcsyes
63824072283rxnav_ndcsyes
01150900011rxnav_historical
11509001101rxnav_historical
21695076216rxnav_historical
63824071008rxnav_historical
63824071016rxnav_historical
63824071098rxnav_historical
63824071116rxnav_historical
63824071194rxnav_historical
63824071198rxnav_historical
63824071216rxnav_historical
63824071294rxnav_historical
63824071298rxnav_historical
63824071536rxnav_historical
63824072083rxnav_historical
63824072116rxnav_historical
63824072216rxnav_historical
63824072482rxnav_historical
63824072483rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
941e36dd-d8d0-4e5c-8585-10e8f06bf8f0Cepacol Sore Throat Pain Relief 15/3.6 Oral LozengeSY11Cēpacol ® Extra Strength Sore Throat cherry20260512
941e36dd-d8d0-4e5c-8585-10e8f06bf8f0Cepacol Sore Throat Pain Relief 15/3.6 (benzocaine / menthol) Oral LozengeSY11Cēpacol ® Extra Strength Sore Throat cherry20260512
941e36dd-d8d0-4e5c-8585-10e8f06bf8f0Cepacol Sore Throat 15 MG / 3.6 MG Oral LozengePSN11Cēpacol ® Extra Strength Sore Throat cherry20260512
941e36dd-d8d0-4e5c-8585-10e8f06bf8f0benzocaine 15 MG / menthol 3.6 MG Oral Lozenge [Cepacol Sore Throat Pain Relief]SBD11Cēpacol ® Extra Strength Sore Throat cherry20260512

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
941e36dd-d8d0-4e5c-8585-10e8f06bf8f0Cēpacol ® Extra Strength Sore Throat cherryReckitt Benckiser LLC20260512

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
FDASPLN0000185508Standardized Chemical AllergenEPChas_epcbenzocaine
FDASPLN0000184306Cell-mediated ImmunityPEhas_pebenzocaine
FDASPLN0000175629Increased Histamine ReleasePEhas_pebenzocaine
MEDRTD001566BenzocaineCHEMhas_ingredientbenzocaine
MEDRTD008610MentholCHEMhas_ingredientmenthol
MEDRTD001424Bacterial InfectionsDISEASEci_withbenzocaine
MEDRTD002056BurnsDISEASEmay_treatbenzocaine
MEDRTD004342Drug HypersensitivityDISEASEci_withmenthol
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
MEDRTD010146PainDISEASEmay_treatmenthol
MEDRTD011537PruritusDISEASEmay_treatbenzocaine
MEDRTD012871Skin DiseasesDISEASEmay_treatmenthol
MEDRTD014098ToothacheDISEASEmay_treatbenzocaine
MEDRTN0000000069Calcium Channel AntagonistsMOAhas_moamenthol
MEDRTN0000000180Sodium Channel InteractionsMOAhas_moabenzocaine
MEDRTN0000008889Decreased Sensory-Somatic Nervous System Organized Electrical ActivityPEhas_pebenzocaine
MEDRTN0000008889Decreased Sensory-Somatic Nervous System Organized Electrical ActivityPEhas_pementhol

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH15 MG / 3.6 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSBD
CODESMMSL_CODEBD25325
CODESRxCUI1235477
CODESSPL_SET_ID941e36dd-d8d0-4e5c-8585-10e8f06bf8f0
NAMESPrescribable SynonymCepacol Sore Throat 15 MG / 3.6 MG Oral Lozenge
NAMESRXNAV_STRCepacol Sore Throat Pain Relief 15/3.6 Oral Lozenge
NAMESRxNorm Namebenzocaine 15 MG / menthol 3.6 MG Oral Lozenge [Cepacol Sore Throat Pain Relief]
NAMESRxNorm SynonymCepacol Sore Throat Pain Relief 15/3.6 (benzocaine / menthol) Oral Lozenge
NAMESRxNorm SynonymCepacol Sore Throat Pain Relief 15/3.6 Oral Lozenge
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon