FDA.reportPublic FDA data

benzocaine 200 MG/ML Oral Spray

RxCUI
1435490
RxNorm name
benzocaine 200 MG/ML Oral Spray
Term type
SCD
Status
Active
Updated
2026-08-10 06:55:31

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
092013
Active start
092013
Multiple ingredient
NO
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
benzocaine200 MG / 1 MLbenzocainebenzocaine

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Spray346164

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
benzocaine1399

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
RXNAV_STRbenzocaine 200 MG/ML Oral SprayNAMES
RxNorm Namebenzocaine 200 MG/ML Oral SprayNAMES
RxNorm Synonymbenzocaine 20 % Oral SprayNAMES
TTYSCDATTRIBUTES
SPL_SET_ID351ecc2b-cc1a-2bbf-e063-6394a90a5c14CODES
SPL_SET_ID4d3e03ee-6e0f-c9ae-e063-6394a90a6f5bCODES
SPL_SET_ID541e1814-c00e-efdf-e063-6394a90a41a1CODES
RxCUI1435490CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
55758-505-0155758-505Dolodent BenzocainePharmadel LLCM022
66975-360-3566975-360BencoCaine Topical Anesthetic BenzocaineBenco DentalM022

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M02255758-505Dolodent BenzocaineOTC MONOGRAPH DRUGPharmadel LLC

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 4 matching rows.

NDC11, Source, Active table
NDC11SourceActive
55758050501rxnav_ndcsyes
66975036035rxnav_ndcsyes
87786000101rxnav_ndcsyes
53045012560rxnav_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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TideFresh MOUTH SORE AND TOOTHACHEBENZOCAINE 20% MOUTH SORE AND TOOTHACHEWenzhou Yuyuan Pharmaceutical Co., Ltd.541e1814-c00e-efdf-e063-6394a90a41a12026-06-13WarningsExact identifier
ndc11 (package): 87786000101
rxcui: 1435490
Dolodent Maximum StrengthBENZOCAINEPharmadel LLC351ecc2b-cc1a-2bbf-e063-6394a90a5c142026-05-26WarningsExact identifier
ndc (package): 55758-505-01
ndc (product): 55758-505
ndc11 (package): 55758050501
rxcui: 1435490
BencoCaine Topical AnestheticBENZOCAINEBenco Dental4d3e03ee-6e0f-c9ae-e063-6394a90a6f5b2026-03-17WarningsExact identifier
ndc (package): 66975-360-35
ndc (product): 66975-360
ndc11 (package): 66975036035
rxcui: 1435490
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc9991de96-99a1-42f0-9ddd-e530ca9ceab12024-04-11WarningsExact identifier
rxcui: 1435490

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
9991de96-99a1-42f0-9ddd-e530ca9ceab1benzocaine 200 MG/ML Oral SpraySCD720240411
9991de96-99a1-42f0-9ddd-e530ca9ceab1benzocaine 20 % Oral SprayPSN720240411
9991de96-99a1-42f0-9ddd-e530ca9ceab1benzocaine 20 % Oral SpraySY720240411
351ecc2b-cc1a-2bbf-e063-6394a90a5c14benzocaine 20 % Oral SprayPSN4DoloDent (WP)20260526
351ecc2b-cc1a-2bbf-e063-6394a90a5c14benzocaine 200 MG/ML Oral SpraySCD4DoloDent (WP)20260526
351ecc2b-cc1a-2bbf-e063-6394a90a5c14benzocaine 20 % Oral SpraySY4DoloDent (WP)20260526
4d3e03ee-6e0f-c9ae-e063-6394a90a6f5bbenzocaine 20 % Oral SpraySY120260317
4d3e03ee-6e0f-c9ae-e063-6394a90a6f5bbenzocaine 20 % Oral SprayPSN120260317
4d3e03ee-6e0f-c9ae-e063-6394a90a6f5bbenzocaine 200 MG/ML Oral SpraySCD120260317

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
541e1814-c00e-efdf-e063-6394a90a41a187786-001Wenzhou Yuyuan Pharmaceutical Co., Ltd.20260613
351ecc2b-cc1a-2bbf-e063-6394a90a5c14DoloDent (WP)Pharmadel LLC20260526
4d3e03ee-6e0f-c9ae-e063-6394a90a6f5bBenco Dental20260317
351ecc2b-cc1a-2bbf-e063-6394a90a5c14DoloDent (WP)(DA)Pharmadel LLC20251204
2b4a6b21-396a-4b07-b1b9-751643cb5821Dharma Research, inc.20130101

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
MEDRTD001424Bacterial InfectionsDISEASEci_withbenzocaine
MEDRTD002056BurnsDISEASEmay_treatbenzocaine
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
MEDRTN0000000180Sodium Channel InteractionsMOAhas_moabenzocaine
MEDRTN0000008889Decreased Sensory-Somatic Nervous System Organized Electrical ActivityPEhas_pebenzocaine

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESACTIVATED01/28/2025
ATTRIBUTESAVAILABLE_STRENGTH200 MG/ML
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESTTYSCD
CODESRxCUI1435490
CODESSPL_SET_ID351ecc2b-cc1a-2bbf-e063-6394a90a5c14
CODESSPL_SET_ID4d3e03ee-6e0f-c9ae-e063-6394a90a6f5b
CODESSPL_SET_ID541e1814-c00e-efdf-e063-6394a90a41a1
NAMESPrescribable Synonymbenzocaine 20 % Oral Spray
NAMESRXNAV_STRbenzocaine 200 MG/ML Oral Spray
NAMESRxNorm Namebenzocaine 200 MG/ML Oral Spray
NAMESRxNorm Synonymbenzocaine 20 % Oral Spray
SOURCESSourceMetathesaurus FDA Structured Product Labels