FDA.reportPublic FDA data

benzalkonium chloride 1 MG/ML / benzocaine 50 MG/ML Topical Spray

RxCUI
1245229
RxNorm name
benzalkonium chloride 1 MG/ML / benzocaine 50 MG/ML Topical Spray
Display name
Benzalkonium/Benzocaine (Topical)
Full name
benzalkonium chloride 1 MG/ML / benzocaine 50 MG/ML Topical Spray
Term type
SCD
Status
Active
Strength
0.1-5%
Dose form
Spray
Route
Topical
Updated
2026-06-06 07:16:13

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
032012
Active start
032012
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
benzalkonium chloride1 MG / 1 MLbenzalkoniumbenzalkonium chloride
benzocaine50 MG / 1 MLbenzocainebenzocaine

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Topical Spray346165

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
benzalkonium1378
benzocaine1399

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRbenzalkonium chloride 1 MG/ML / benzocaine 50 MG/ML Topical SprayNAMES
RxNorm Namebenzalkonium chloride 1 MG/ML / benzocaine 50 MG/ML Topical SprayNAMES
RxNorm Synonymbenzalkonium Cl 0.1 % / benzocaine 5 % Topical SprayNAMES
TTYSCDATTRIBUTES
SPL_SET_ID1fd15b91-6b81-d0bd-e063-6294a90a4d27CODES
SPL_SET_ID35d06b38-55dd-e306-e063-6394a90aaf26CODES
SPL_SET_ID458e65f2-826d-4550-8c7d-17add2d7ba9aCODES
SPL_SET_IDa6d258ed-6d6d-42f0-9994-6c2c4c3d0f4aCODES
RxCUI1245229CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0924-0938-010924-0938First Aid Only Antiseptic First Aid Benzalkonium ChlorideAcme United CorporationM003
50332-0212-150332-0212First Aid Benzalkonium Chloride, BenzocaineHART HealthM
61010-5300-061010-5300Antiseptic benzalkonium chloride, benzocaineSafetec of America, Inc.M003
61010-5300-261010-5300Antiseptic benzalkonium chloride, benzocaineSafetec of America, Inc.M003
84269-3501-184269-3501Antiseptic benzalkonium chloride, benzocaineWildman Business GroupM003

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M0030924-0938First Aid Only Antiseptic First Aid Benzalkonium ChlorideOTC MONOGRAPH DRUGAcme United Corporation
M50332-0212First Aid Benzalkonium Chloride, BenzocaineOTC MONOGRAPH DRUGHART Health

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
00924093801rxnav_ndcsyes
50332021201rxnav_ndcsyes
61010530000rxnav_ndcsyes
61010530002rxnav_ndcsyes
84269350101rxnav_ndcsyes
00924093101rxnav_historical
47682024402rxnav_historical
47682024417rxnav_historical
47682030602rxnav_historical
49314009801rxnav_historical
51532530003rxnav_historical
62985508101rxnav_historical
69103350101rxnav_historical
71338012002rxnav_historical
81238530001rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
a6d258ed-6d6d-42f0-9994-6c2c4c3d0f4abenzalkonium chloride 0.1 % / benzocaine 5 % Topical SprayPSN5FIRST AID SPRAY20240118
a6d258ed-6d6d-42f0-9994-6c2c4c3d0f4abenzalkonium chloride 1 MG/ML / benzocaine 50 MG/ML Topical SpraySCD5FIRST AID SPRAY20240118
a6d258ed-6d6d-42f0-9994-6c2c4c3d0f4abenzalkonium Cl 0.1 % / benzocaine 5 % Topical SpraySY5FIRST AID SPRAY20240118
458e65f2-826d-4550-8c7d-17add2d7ba9abenzalkonium chloride 0.1 % / benzocaine 5 % Topical SprayPSN461010-5300, Cut and Scrape Antiseptic20240207
458e65f2-826d-4550-8c7d-17add2d7ba9abenzalkonium Cl 0.1 % / benzocaine 5 % Topical SpraySY461010-5300, Cut and Scrape Antiseptic20240207
458e65f2-826d-4550-8c7d-17add2d7ba9abenzalkonium chloride 1 MG/ML / benzocaine 50 MG/ML Topical SpraySCD461010-5300, Cut and Scrape Antiseptic20240207
3eb119d8-59da-405c-a5f4-a025636d394abenzalkonium chloride 0.1 % / benzocaine 5 % Topical SprayPSN420230112
3eb119d8-59da-405c-a5f4-a025636d394abenzalkonium chloride 1 MG/ML / benzocaine 50 MG/ML Topical SpraySCD420230112
3eb119d8-59da-405c-a5f4-a025636d394abenzalkonium Cl 0.1 % / benzocaine 5 % Topical SpraySY420230112
66b16c15-8b3f-4793-8c5f-3f85d65c8340benzalkonium chloride 1 MG/ML / benzocaine 50 MG/ML Topical SpraySCD320141006
66b16c15-8b3f-4793-8c5f-3f85d65c8340benzalkonium chloride 0.1 % / benzocaine 5 % Topical SprayPSN320141006
66b16c15-8b3f-4793-8c5f-3f85d65c8340benzalkonium Cl 0.1 % / benzocaine 5 % Topical SpraySY320141006
d9018fe1-4255-4d4f-94f4-022d85448072benzalkonium chloride 0.1 % / benzocaine 5 % Topical SprayPSN2aramark Antiseptic Spray20210526
d9018fe1-4255-4d4f-94f4-022d85448072benzalkonium chloride 1 MG/ML / benzocaine 50 MG/ML Topical SpraySCD2aramark Antiseptic Spray20210526
d9018fe1-4255-4d4f-94f4-022d85448072benzalkonium Cl 0.1 % / benzocaine 5 % Topical SpraySY2aramark Antiseptic Spray20210526
e415a3c8-5ca3-4593-b0a6-0c12d3e0ccfabenzalkonium chloride 0.1 % / benzocaine 5 % Topical SprayPSN220150127
e415a3c8-5ca3-4593-b0a6-0c12d3e0ccfabenzalkonium Cl 0.1 % / benzocaine 5 % Topical SpraySY220150127
e415a3c8-5ca3-4593-b0a6-0c12d3e0ccfabenzalkonium chloride 1 MG/ML / benzocaine 50 MG/ML Topical SpraySCD220150127
673646aa-906c-424a-a2f4-07048160c5dcbenzalkonium chloride 1 MG/ML / benzocaine 50 MG/ML Topical SpraySCD220140813
673646aa-906c-424a-a2f4-07048160c5dcbenzalkonium chloride 0.1 % / benzocaine 5 % Topical SprayPSN220140813
673646aa-906c-424a-a2f4-07048160c5dcbenzalkonium Cl 0.1 % / benzocaine 5 % Topical SpraySY220140813
35d06b38-55dd-e306-e063-6394a90aaf26benzalkonium chloride 0.1 % / benzocaine 5 % Topical SprayPSN1First Aid Only Antiseptic First Aid Spray20250523
35d06b38-55dd-e306-e063-6394a90aaf26benzalkonium chloride 1 MG/ML / benzocaine 50 MG/ML Topical SpraySCD1First Aid Only Antiseptic First Aid Spray20250523
35d06b38-55dd-e306-e063-6394a90aaf26benzalkonium Cl 0.1 % / benzocaine 5 % Topical SpraySY1First Aid Only Antiseptic First Aid Spray20250523
1fd15b91-6b81-d0bd-e063-6294a90a4d27benzalkonium Cl 0.1 % / benzocaine 5 % Topical SpraySY184269-3501, Cut and Scrape Antiseptic20240901
1fd15b91-6b81-d0bd-e063-6294a90a4d27benzalkonium chloride 0.1 % / benzocaine 5 % Topical SprayPSN184269-3501, Cut and Scrape Antiseptic20240901
1fd15b91-6b81-d0bd-e063-6294a90a4d27benzalkonium chloride 1 MG/ML / benzocaine 50 MG/ML Topical SpraySCD184269-3501, Cut and Scrape Antiseptic20240901
527232df-20d6-4e10-a478-e42a7a6dc20fbenzalkonium chloride 1 MG/ML / benzocaine 50 MG/ML Topical SpraySCD120140829
527232df-20d6-4e10-a478-e42a7a6dc20fbenzalkonium Cl 0.1 % / benzocaine 5 % Topical SpraySY120140829
527232df-20d6-4e10-a478-e42a7a6dc20fbenzalkonium chloride 0.1 % / benzocaine 5 % Topical SprayPSN120140829

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
35d06b38-55dd-e306-e063-6394a90aaf26First Aid Only Antiseptic First Aid SprayAcme United Corporation20250523
1fd15b91-6b81-d0bd-e063-6294a90a4d2784269-3501, Cut and Scrape AntisepticWildman Business Group | Safetec of America Inc | Safetec of America, Inc.20240901
458e65f2-826d-4550-8c7d-17add2d7ba9a61010-5300, Cut and Scrape AntisepticSafetec of America, Inc.20240207
a6d258ed-6d6d-42f0-9994-6c2c4c3d0f4aFIRST AID SPRAYHART Health20240118
3eb119d8-59da-405c-a5f4-a025636d394aAfassco Inc. | Safetec of America, Inc.20230112
d9018fe1-4255-4d4f-94f4-022d85448072aramark Antiseptic SprayWestern First Aid Safety DBA Aramark | Safetec of America, Inc.20210526
e415a3c8-5ca3-4593-b0a6-0c12d3e0ccfaUnishield | Safetec of America, Inc. | Safetec of America, Inc20150127
66b16c15-8b3f-4793-8c5f-3f85d65c8340Acme United Corp | Safetec of America, Inc20141006
527232df-20d6-4e10-a478-e42a7a6dc20fProvision Medical | Safetec of America, Inc.20140829
673646aa-906c-424a-a2f4-07048160c5dcFirst Aid Only | Safetec of America, Inc.20140813

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
ATTRIBUTESAVAILABLE_STRENGTH1 MG/ML / 50 MG/ML
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESTTYSCD
CODESRxCUI1245229
CODESSPL_SET_ID1fd15b91-6b81-d0bd-e063-6294a90a4d27
CODESSPL_SET_ID35d06b38-55dd-e306-e063-6394a90aaf26
CODESSPL_SET_ID458e65f2-826d-4550-8c7d-17add2d7ba9a
CODESSPL_SET_IDa6d258ed-6d6d-42f0-9994-6c2c4c3d0f4a
NAMESPrescribable Synonymbenzalkonium chloride 0.1 % / benzocaine 5 % Topical Spray
NAMESRXNAV_STRbenzalkonium chloride 1 MG/ML / benzocaine 50 MG/ML Topical Spray
NAMESRxNorm Namebenzalkonium chloride 1 MG/ML / benzocaine 50 MG/ML Topical Spray
NAMESRxNorm Synonymbenzalkonium Cl 0.1 % / benzocaine 5 % Topical Spray
SOURCESSourceMetathesaurus FDA Structured Product Labels