FDA.reportPublic FDA data

benzalkonium chloride 0.001 MG/MG / benzocaine 0.2 MG/MG Oral Gel

RxCUI
1595155
RxNorm name
benzalkonium chloride 0.001 MG/MG / benzocaine 0.2 MG/MG Oral Gel
Display name
Benzalkonium/Benzocaine (Oral Gel)
Full name
benzalkonium chloride 0.001 MG/MG / benzocaine 0.2 MG/MG Oral Gel
Term type
SCD
Status
Active
Strength
0.1-20%
Dose form
Gel
Route
Oral Gel
Updated
2026-10-15 14:50:33

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
012015
Active start
012015
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
benzalkonium chloride0.001 MG / 1 MGbenzalkoniumbenzalkonium chloride
benzocaine0.2 MG / 1 MGbenzocainebenzocaine

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Gel346169

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
benzalkonium1378
benzocaine1399

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRbenzalkonium chloride 0.001 MG/MG / benzocaine 0.2 MG/MG Oral Gel1NAMES
RxNorm Namebenzalkonium chloride 0.001 MG/MG / benzocaine 0.2 MG/MG Oral Gel1NAMES
RxNorm Synonymbenzalkonium chloride 0.1 % / benzocaine 20 % Oral Gel1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
4 linked values
4CODES
RxCUI15951551CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
52000-060-0252000-060Oral Pain Relief Benzocaine and Benzalkonium ChlorideUniversal Distribution Center LLCM022
83324-035-1283324-035Quality Choice Oral Pain Relief Benzocaine 20%, Benzalkonium Chloride 1%Quality Choice (CHAIN DRUG MARKETING ASSOCIATION)M022
83650-101-0183650-101Oral Gel Benzocaine Benzalkonium ChlorideSavvy Care and CosmeticsM022

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M02252000-060Oral Pain Relief Benzocaine and Benzalkonium ChlorideOTC MONOGRAPH DRUGUniversal Distribution Center LLC

RxNav Current And Historical NDCs#

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

NDC11, Source, Active table
NDC11SourceActive
47046015601rxnav_ndcsyes
52000006002rxnav_ndcsyes
83324003512rxnav_ndcsyes
83650010101rxnav_ndcsyes
20276056114rxnav_historical
41250078242rxnav_historical
47046015602rxnav_historical
47046016901rxnav_historical
52000006001rxnav_historical
59428050042rxnav_historical
69842034828rxnav_historical
69842034898rxnav_historical
77338020101rxnav_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
Oral Gel Oral Pain ReliefBENZOCAINE BENZALKONIUM CHLORIDESavvy Care and Cosmetics05ede7e4-5a0a-c942-e063-6294a90a8a242024-12-19WarningsExact identifier
ndc (package): 83650-101-01
ndc (product): 83650-101
ndc11 (package): 83650010101
rxcui: 1595155
Quality Choice Oral Pain ReliefBENZOCAINE 20%, BENZALKONIUM CHLORIDE 1%Quality Choice (CHAIN DRUG MARKETING ASSOCIATION)162702b4-4bf7-8868-e063-6294a90a59212024-04-15WarningsExact identifier
ndc (package): 83324-035-12
ndc (product): 83324-035
ndc11 (package): 83324003512

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 · 8 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
baf0cf27-052e-4367-9a6e-75038b97a051benzocaine 20 % / benzalkonium chloride 0.1 % Oral Gel [PSN] · benzalkonium chloride 0.001 MG/MG / benzocaine 0.2 MG/MG Oral Gel [SCD] · benzalkonium chloride 0.1 % / benzocaine 20 % Oral Gel [SY]34Oral Pain Relief Gel20241204
18520f9b-4d35-1e9c-e063-6294a90aaa39benzocaine 20 % / benzalkonium chloride 0.1 % Oral Gel [PSN] · benzalkonium chloride 0.001 MG/MG / benzocaine 0.2 MG/MG Oral Gel [SCD] · benzalkonium chloride 0.1 % / benzocaine 20 % Oral Gel [SY]33Oral Pain Relief Gel20251030
05ede7e4-5a0a-c942-e063-6294a90a8a24benzocaine 20 % / benzalkonium chloride 0.1 % Oral Gel [PSN] · benzalkonium chloride 0.001 MG/MG / benzocaine 0.2 MG/MG Oral Gel [SCD] · benzalkonium chloride 0.1 % / benzocaine 20 % Oral Gel [SY]32Oral gel20241219
1368d8bd-4263-4d8f-8a44-20571a8d6f8cbenzocaine 20 % / benzalkonium chloride 0.1 % Oral Gel [PSN] · benzalkonium chloride 0.001 MG/MG / benzocaine 0.2 MG/MG Oral Gel [SCD] · benzalkonium chloride 0.1 % / benzocaine 20 % Oral Gel [SY]3220161101
12da355e-cea9-7ce3-e063-6394a90a86f1benzocaine 20 % / benzalkonium chloride 0.1 % Oral Gel [PSN] · benzalkonium chloride 0.001 MG/MG / benzocaine 0.2 MG/MG Oral Gel [SCD] · benzalkonium chloride 0.1 % / benzocaine 20 % Oral Gel [SY]31ASTONEA Maximum Strength Oral Pain Relief20240304
b6e14e7f-8535-3de7-e053-2995a90a0e46benzocaine 20 % / benzalkonium chloride 0.1 % Oral Gel [PSN] · benzalkonium chloride 0.001 MG/MG / benzocaine 0.2 MG/MG Oral Gel [SCD] · benzalkonium chloride 0.1 % / benzocaine 20 % Oral Gel [SY]31Lucky Oralgel20201220
b659d3cf-97c5-5ca2-e053-2a95a90a9371benzocaine 20 % / benzalkonium chloride 0.1 % Oral Gel [PSN] · benzalkonium chloride 0.001 MG/MG / benzocaine 0.2 MG/MG Oral Gel [SCD] · benzalkonium chloride 0.1 % / benzocaine 20 % Oral Gel [SY]31Oral Pain Relief Gel20201213
db38f8be-56e1-4e5d-a565-dee523dd1a8bbenzocaine 20 % / benzalkonium chloride 0.1 % Oral Gel [PSN] · benzalkonium chloride 0.001 MG/MG / benzocaine 0.2 MG/MG Oral Gel [SCD] · benzalkonium chloride 0.1 % / benzocaine 20 % Oral Gel [SY]3120161208

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
18520f9b-4d35-1e9c-e063-6294a90aaa39Oral Pain Relief GelUniversal Distribution Center LLC20261021
18520f9b-4d35-1e9c-e063-6294a90aaa39Oral Pain Relief GelUniversal Distribution Center LLC20251030
05ede7e4-5a0a-c942-e063-6294a90a8a24Oral gelSavvy Care and Cosmetics20241219
baf0cf27-052e-4367-9a6e-75038b97a051Oral Pain Relief GelUniversal Distribution Center LLC20241204
18520f9b-4d35-1e9c-e063-6294a90aaa39Oral Pain Relief GelUniversal Distribution Center LLC20241204
162702b4-4bf7-8868-e063-6294a90a5921Quality Choice Oral Pain ReliefQuality Choice (CHAIN DRUG MARKETING ASSOCIATION) | Astonea Labs Private Label20240415
12da355e-cea9-7ce3-e063-6394a90a86f1ASTONEA Maximum Strength Oral Pain ReliefASTONEA LABS PRIVATE LIMITED20240304
5dbfa3ae-2994-45d5-b799-a2638d87d9e8Lucky OralgelDelta Brands Inc20230907
b6e14e7f-8535-3de7-e053-2995a90a0e46Lucky OralgelAnicare Pharmaceuticals Pvt. Ltd.20201220
b659d3cf-97c5-5ca2-e053-2a95a90a9371Oral Pain Relief GelAnicare Pharmaceuticals Pvt. Ltd20201213
db38f8be-56e1-4e5d-a565-dee523dd1a8bMEIJER DISTRIBUTION INC20161208
1368d8bd-4263-4d8f-8a44-20571a8d6f8cProductos Zapotol Corp.20161101

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCD04ABAnesthetics for topical useATC1-4benzocaine
ATCR02ADAnesthetics, localATC1-4benzocaine
ATCR02AAAntisepticsATC1-4benzalkonium
ATCN01BAEsters of aminobenzoic acidATC1-4benzocaine
ATCC05ADLocal anestheticsATC1-4benzocaine
ATCD09AAMedicated dressings with antiinfectivesATC1-4benzalkonium
ATCD08AJQuaternary ammonium compoundsATC1-4benzalkonium
FDASPLN0000185508Standardized Chemical AllergenEPChas_epcbenzocaine
FDASPLN0000184306Cell-mediated ImmunityPEhas_pebenzocaine
FDASPLN0000175629Increased Histamine ReleasePEhas_pebenzocaine
MEDRTD001548Benzalkonium CompoundsCHEMhas_ingredientbenzalkonium
MEDRTD001548Benzalkonium CompoundsCHEMhas_ingredientbenzalkonium chloride
MEDRTD001566BenzocaineCHEMhas_ingredientbenzocaine
MEDRTD001424Bacterial InfectionsDISEASEmay_preventbenzalkonium
MEDRTD001424Bacterial InfectionsDISEASEmay_preventbenzalkonium chloride
MEDRTD001424Bacterial InfectionsDISEASEci_withbenzocaine
MEDRTD002056BurnsDISEASEmay_treatbenzocaine
MEDRTD004342Drug HypersensitivityDISEASEci_withbenzalkonium chloride
MEDRTD004342Drug HypersensitivityDISEASEci_withbenzalkonium
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
ATTRIBUTESACTIVATED12/02/2020
ATTRIBUTESAVAILABLE_STRENGTH0.001 MG/MG / 0.2 MG/MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
NAMESPrescribable Synonymbenzocaine 20 % / benzalkonium chloride 0.1 % Oral Gel
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceNational Drug Data File Plus Source Vocabulary