Benzo Jel

Product NDC
0404-0018
11-digit product format
004040018
Labeler code
0404
Product ID
0404-0018_1172e39c-cc41-33c5-e063-6294a90a8d4b
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
SPRAY, METERED
Route
DENTAL
Labeler
Henry Schein Inc.
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-02-01
Substance
BENZOCAINE
Active strength
11.4 g/57g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Benzo Jel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE11.4 g/57g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
360348Internal RxNorm lookup
1742420Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2cd571fc-30ee-40da-a2c7-25adb7d4b5c3Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0404-0018-352024-01-30C16284748780-11030e365-4dac-111a-e063-dadaa90a10e22cd571fc-30ee-40da-a2c7-25adb7d4b5c3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-0018-35Benzo Jel57 g in 1 BOTTLE, SPRAYSPRAY, METERED576

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-0018BENZO JEL (BENZOCAINE) SPRAY, METERED [HENRY SCHEIN INC.]6Current NDC, Legacy NDC, 1 package rows20240217_2cd571fc-30ee-40da-a2c7-25adb7d4b5c3.zip

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 23 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BENZOYL PEROXIDE 5% Topical washBENZOYL PEROXIDEMedcore LLC14bf3034-2fe8-44b9-9e26-e804b60468372025-10-22WarningsExact identifier
application number: M006
Perricone MD Acne Relief Retinol Treatment and MoisturizerSALICYLIC ACIDTHG Beauty USA LLC41ac6e4e-59ad-6d80-e063-6394a90adc012025-10-21WarningsExact identifier
application number: M006
Clear Smart Blemish Spot TreatmentSALICYCLIC ACIDDistribuidora Comercial Jafra, S.A. de C.Va568186c-543b-5d44-e053-2995a90aa4912025-10-21WarningsExact identifier
application number: M006
Clear Smart Clear Complexion TonerSALICYLIC ACIDDistribuidora Comercial Jafra, S.A. de C.V.a517dfe5-e4a0-5f2d-e053-2a95a90a2ec12025-10-21WarningsExact identifier
application number: M006
Clear Smart Clarifying Cleansing FoamSALICYLIC ACIDDistribuidora Comercial Jafra, S.A. de C.V.a564d38c-d674-29db-e053-2995a90ab3b42025-10-21WarningsExact identifier
application number: M006
Clear Smart Clear Pore HydratorSALICYLIC ACIDDistribuidora Comercial Jafra, S.A. de C.V.dd6e63a6-91d8-41de-9cb7-f88b68c528d02025-10-21WarningsExact identifier
application number: M006
Acne Fighting Putty PrimerSALICYLIC ACIDe.l.f. Cosmetics, Inc657fd325-dd3f-4246-8486-fb5405a52c612025-10-21WarningsExact identifier
application number: M006
Acne Fighting Spot GelSALICYLIC ACIDe.l.f. Cosmetics, Inceca08910-58b9-4ce6-8e97-4b97c30784f52025-10-21WarningsExact identifier
application number: M006
Blemish Control Basics KitSALICYLIC ACIDe.l.f. Cosmetics, Inc1caf8dbb-18c2-48e9-a8b2-f4f53a4a32d22025-10-21WarningsExact identifier
application number: M006
Oil-Free Foaming Acne WashSALICYLIC ACIDRejoice Internationalcfc2efe1-3eb4-4262-ba68-d1201770297c2025-10-20WarningsExact identifier
application number: M006
Dr.Mellaxeen SKIN SAVER DAILY ACNE ESSENTIALS KitSALICYLIC ACIDLongway Lab Inc.41931e38-0e3c-e322-e063-6394a90af4012025-10-20WarningsExact identifier
application number: M006
Acne WashSALICYLIC ACIDTarget Corporation1c81d366-3bf9-c33e-e063-6294a90a3ca22025-10-18WarningsExact identifier
application number: M006
Dr Mellaxeen SKIN SAVER ACNE RELIEF StickSALICYLIC ACIDLongway Technology(Guangzhou) Co., Ltd.41672e2e-2b70-e879-e063-6294a90a81b02025-10-17WarningsExact identifier
application number: M006
SOME BY MI AHA BHA PHA 30 DAYS MIRACLE ACNE CLEAR FOAMSOME BY MI AHA BHA PHA 30 DAYS MIRACLE ACNE CLEAR FOAMPERENNEBELL Co., Ltd.0897ccca-fa18-873f-e063-6394a90a59ab2025-10-16WarningsExact identifier
application number: M006
Acne Calming Water CreamSALICYLIC ACIDe.l.f. Cosmetics, Inc.01b70e53-9e24-4950-bbe9-c58905b6e68d2025-10-15WarningsExact identifier
application number: M006
Acne Clarifying CleanserSALICYLIC ACIDe.l.f. Cosmetics, Inc.0e9be1e3-7fa9-4d70-9c89-cf7501d2380b2025-10-15WarningsExact identifier
application number: M006
Acne Body WashSALICYLIC ACIDCurology9e057f84-0b46-4ffc-a3bb-5bafc8f6baa52025-10-15WarningsExact identifier
application number: M006
Acne Body WashSALICYLIC ACIDCurology1c2d71c5-2560-462f-adec-14bc38550ba42025-10-15WarningsExact identifier
application number: M006
Purifying Clay MaskSALICYLIC ACIDCosmetic Enterprises Ltdd17e3ff5-f7a4-3e14-e053-2995a90a22b22025-10-14WarningsExact identifier
application number: M006
Stage Fight Acne MaskSULFUR, RESORCINOLCosmetic Enterprises Ltd209e321e-ed20-9c67-e063-6394a90a54102025-10-14WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1742420Benzo-Jel 20 % Mucosal SprayPSN2cd571fc-30ee-40da-a2c7-25adb7d4b5c36
360348benzocaine 20 % Mucosal SprayPSN2cd571fc-30ee-40da-a2c7-25adb7d4b5c36
1742420benzocaine 200 MG/ML Mucosal Spray [Benzo-Jel]SBD2cd571fc-30ee-40da-a2c7-25adb7d4b5c36
360348benzocaine 200 MG/ML Mucosal SpraySCD2cd571fc-30ee-40da-a2c7-25adb7d4b5c36
1742420Benzo-Jel 20 % Dental SpraySY2cd571fc-30ee-40da-a2c7-25adb7d4b5c36
1742420Benzo-Jel 20 % Mucosal SpraySY2cd571fc-30ee-40da-a2c7-25adb7d4b5c36
1742420Benzo-Jel 200 MG/ML Mucosal SpraySY2cd571fc-30ee-40da-a2c7-25adb7d4b5c36
360348benzocaine 20 % Mucosal SpraySY2cd571fc-30ee-40da-a2c7-25adb7d4b5c36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0404-0018-350040400183557 g in 1 BOTTLE, SPRAY (0404-0018-35) 57 g2016-02-010000-00-00NoNoCurrent