FDA.reportPublic FDA data

benzocaine 20 MG/ML / cetylpyridinium chloride 1 MG/ML / menthol 5 MG/ML Mucosal Spray [Orasep Reformulated Dec 2013]

RxCUI
1485227
RxNorm name
benzocaine 20 MG/ML / cetylpyridinium chloride 1 MG/ML / menthol 5 MG/ML Mucosal Spray [Orasep Reformulated Dec 2013]
Display name
ORASEP REFORMULATED DEC 2013 (Mucosal)
Full name
benzocaine 20 MG/ML / cetylpyridinium chloride 1 MG/ML / menthol 5 MG/ML Mucosal Spray [Orasep Reformulated Dec 2013]
Term type
SBD
Status
Active
Strength
2-0.1-0.5%
Dose form
Spray
Route
Mucosal
Updated
2026-08-10 19:20:04

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
012014
Active start
012014
Multiple ingredient
YES
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
benzocaine20 MG / 1 MLbenzocainebenzocaine
cetylpyridinium chloride1 MG / 1 MLcetylpyridiniumcetylpyridinium chloride
menthol5 MG / 1 MLmentholmenthol

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Mucosal Spray346163

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
benzocaine1399
cetylpyridinium2286
menthol6750

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STROrasep (benzocaine 2 % / menthol 0.5 % / cetylpyridinium chloride 0.1 % ) Mucosal Spray, Reformulated Dec 20131NAMES
RxNorm Namebenzocaine 20 MG/ML / cetylpyridinium chloride 1 MG/ML / menthol 5 MG/ML Mucosal Spray [Orasep Reformulated Dec 2013]1NAMES
RxNorm SynonymOrasep (benzocaine 2 % / menthol 0.5 % / cetylpyridinium chloride 0.1 % ) Mucosal Spray, Reformulated Dec 20131NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID7c50d986-6a7b-425f-90a0-a60e21283bdf1CODES
RxCUI14852271CODES
MMSL_CODEBD279571CODES

RxNav Current And Historical NDCs#

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

NDC11, Source, Active table
NDC11SourceActive
54859050401rxnav_ndcsyes

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
7c50d986-6a7b-425f-90a0-a60e21283bdfOrasep 2 % / 0.5 % / 0.1 % Mucosal Spray, Reformulated Dec 2013 [PSN] · benzocaine 20 MG/ML / cetylpyridinium chloride 1 MG/ML / menthol 5 MG/ML Mucosal Spray [Orasep Reformulated Dec 2013] [SBD] · Orasep (benzocaine 2 % / menthol 0.5 % / cetylpyridinium chloride 0.1 % ) Mucosal Spray, Reformulated Dec 2013 [SY]37Llorens- Orasep Spray 50420251231

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
7c50d986-6a7b-425f-90a0-a60e21283bdfLlorens- Orasep Spray 504Llorens Pharmaceutical International Division | Lex Inc.20251231
e2edd111-a748-40aa-aee8-d56f0533277dNational Council for Prescription Drug Programs20120724

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCD04ABAnesthetics for topical useATC1-4benzocaine
ATCR02ADAnesthetics, localATC1-4benzocaine
ATCB05CAAntiinfectivesATC1-4cetylpyridinium
ATCR02AAAntisepticsATC1-4cetylpyridinium
ATCN01BAEsters of aminobenzoic acidATC1-4benzocaine
ATCC05ADLocal anestheticsATC1-4benzocaine
ATCD09AAMedicated dressings with antiinfectivesATC1-4cetylpyridinium
ATCD08AJQuaternary ammonium compoundsATC1-4cetylpyridinium
FDASPLN0000185508Standardized Chemical AllergenEPChas_epcbenzocaine
FDASPLN0000184306Cell-mediated ImmunityPEhas_pebenzocaine
FDASPLN0000175629Increased Histamine ReleasePEhas_pebenzocaine
MEDRTD001566BenzocaineCHEMhas_ingredientbenzocaine
MEDRTD002594CetylpyridiniumCHEMhas_ingredientcetylpyridinium chloride
MEDRTD002594CetylpyridiniumCHEMhas_ingredientcetylpyridinium
MEDRTD008610MentholCHEMhas_ingredientmenthol
MEDRTD001424Bacterial InfectionsDISEASEci_withbenzocaine
MEDRTD002056BurnsDISEASEmay_treatbenzocaine
MEDRTD003773Dental PlaqueDISEASEmay_preventcetylpyridinium chloride
MEDRTD003773Dental PlaqueDISEASEmay_preventcetylpyridinium
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_treatmenthol
MEDRTD010146PainDISEASEmay_preventbenzocaine
MEDRTD011537PruritusDISEASEmay_treatbenzocaine
MEDRTD012871Skin DiseasesDISEASEmay_treatmenthol
MEDRTD014098ToothacheDISEASEmay_treatbenzocaine
MEDRTN0000000069Calcium Channel AntagonistsMOAhas_moamenthol
MEDRTN0000000180Sodium Channel InteractionsMOAhas_moabenzocaine
MEDRTN0000008889Decreased Sensory-Somatic Nervous System Organized Electrical ActivityPEhas_pementhol
MEDRTN0000008889Decreased Sensory-Somatic Nervous System Organized Electrical ActivityPEhas_pebenzocaine

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH20 MG/ML / 1 MG/ML / 5 MG/ML
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
NAMESPrescribable SynonymOrasep 2 % / 0.5 % / 0.1 % Mucosal Spray, Reformulated Dec 2013
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon