FDA.reportPublic FDA data

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 5 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
10% Azelaic AcidAZELAIC ACID CREAMGuangzhou Ariel Medical Technology Co., Ltd.55b03daa-b6d4-9edf-e063-6394a90ac4d12026-07-03WarningsExact identifier
application number: M006
Hero Mighty CleanserSALICYLIC ACIDChurch & Dwight Co., Inc.5597df54-2e58-0d6a-e063-6394a90a16972026-07-01WarningsExact identifier
application number: M006
Hero Pore CleanserSALICYLIC ACIDChurch & Dwight Co., Inc.559987c0-7abe-13fc-e063-6294a90a9f272026-07-01WarningsExact identifier
application number: M006
Acne Treatment Cream2% SALICYLIC ACIDZytrell Skin Solutions Inc.555be487-92d8-6220-e063-6394a90a0c0a2026-06-28WarningsExact identifier
application number: M006
SKINTIFIC 3X ACID INTENSIVE ACNE TREATMENTSALICYLIC ACIDLongway Technology(Guangzhou)Co., Ltd.553957ef-cb8a-e75d-e063-6394a90a261b2026-06-27WarningsExact identifier
application number: M006
ORLASKIN ACNE TreatmentSALICYLIC ACIDGuangzhou Yapheon Health Industry Co., Ltd.552bf5df-0a3c-7c10-e063-6394a90a311f2026-06-26WarningsExact identifier
application number: M006
ORLASKIN SALICYLIC ACID ACNE TREATMENT PADSSALICYLIC ACIDGuangzhou Yapheon Health Industry Co., Ltd.552c9e72-db4b-641a-e063-6294a90a29012026-06-26WarningsExact identifier
application number: M006
CosmoClear CleanserSALICYLIC ACIDNoon Aesthetics M.R. Ltddd738dfd-676b-40fe-8b0e-3d8305e0fdcb2026-06-25WarningsExact identifier
application number: M006
Walgreens Acne Foaming CleanserBENZOYL PEROXIDEWALGREEN COMPANY549fddb8-9d42-16cb-e063-6294a90aa2a92026-06-19WarningsExact identifier
application number: M006
Walgreens Maximum Strength Acne TreatmentBENZOYL PEROXIDEWALGREEN COMPANY548e327b-1a4f-03df-e063-6294a90a39322026-06-18WarningsExact identifier
application number: M006
EpochSALICYLIC ACIDNSE Products, Inc.3084ac37-de1f-4218-9471-6a5ebf720eb92026-06-17WarningsExact identifier
application number: M006
VICHY LABORATOIRES NORMADERM ACNE CONTROL DAILY MOISTURIZERSALICYLIC ACIDLOreal USA Products Inc17b7a58b-97f2-429f-83cb-db04631d307d2026-06-16WarningsExact identifier
application number: M006
VICHY LABORATOIRES NORMADERM ACNE CONTROL DAILY MOISTURIZERSALICYLIC ACIDCosmetique Active Production17b8a58b-97f2-429f-83cb-db04631d307d2026-06-16WarningsExact identifier
application number: M006
Societe Clarity BacSALICYLIC ACIDSociete Clinical Skincare545130ce-46f9-c231-e063-6394a90a1ea82026-06-16WarningsExact identifier
application number: M006
ES Salicylic WashSALICYLIC ACIDElaine Sterling Enterprises543ab052-5aa9-6585-e063-6394a90af88f2026-06-16WarningsExact identifier
application number: M006
Societe Clear Skin PadsSALICYLIC ACIDSociete Clinical Skincare543a4347-d7d8-3050-e063-6294a90ab3a22026-06-16WarningsExact identifier
application number: M006
FHF Crisp StartACNE CLEANSERSummer Soles LLC dba Farmhouse Fresh Goods54391292-263d-253e-e063-6394a90a742f2026-06-16WarningsExact identifier
application number: M006
FHF Change Peel PadsSALICYLIC PADSSummer Soles, LLC dba Farmhouse Fresh Goods5439a9dd-786c-9140-e063-6394a90a8fa92026-06-16WarningsExact identifier
application number: M006
FHF Day BreakthruSALICYLIC SERUMSummer Doles dba Farmhouse Fresh Fresh Goods54397bb7-1845-72a7-e063-6394a90abbd12026-06-16WarningsExact identifier
application number: M006
Societe Daily ExfoliationSALICYLIC ACIDSociete Clinical Skincare54633a24-3761-14d7-e063-6294a90a89f92026-06-16WarningsExact 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