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 6 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlowBiotic Probiotic Acne CleanserSALICYLIC ACIDGlowbiotics546334bf-cf47-a1e5-e063-6394a90a590c2026-06-16WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M MultiTarget Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Inc5464d48b-495c-e45f-e063-6394a90aedfc2026-06-16WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M MultiTarget Acne TreatmentSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTION54650326-1582-26b7-e063-6394a90a575c2026-06-16WarningsExact identifier
application number: M006
Butterflys tear MILIA REMOVERSALICYLIC ACID 1% MILIA REMOVERJiangxi Yudexi Pharmaceutical Co., LTD52226dfd-eafa-42d7-e063-6394a90a16ef2026-06-12WarningsExact identifier
application number: M006
Proven Acne CleanserSALICYLIC ACIDProven Skincare316702b8-4f9d-0a42-e063-6394a90ad8e12026-06-11WarningsExact identifier
application number: M006
Proven Acne CleanserSALICYLIC ACIDProven Skincare31a29bdd-a218-247a-e063-6294a90a8cee2026-06-11WarningsExact identifier
application number: M006
Clopoat CLOPOAT ACNE-CLEARING SPOTCOLLOIDAL SULFURGuangzhou Meixi Biotechnology Co., Ltd.53cd1d6b-d44c-2508-e063-6294a90a96c62026-06-09WarningsExact identifier
application number: M006
Good Molecules Acne Foaming CleanserSALICYLIC ACIDTwincraft Inc.4911ef14-b465-3398-e063-6394a90a9c9a2026-06-09WarningsExact identifier
application number: M006
PanOxyl Pore Refining Acne MaskSULFURCrown Laboratories, Inc.5373574c-95be-dd88-e063-6394a90ae5192026-06-05WarningsExact identifier
application number: M006
Acne Control SerumBENZOYL PEROXIDEPrivate Label Skin Cared4a4b89f-c9cf-4188-9c61-e8ef22b7638c2026-06-03WarningsExact identifier
application number: M006
BellamiLuxx Body acne cleanserBENZOYL PEROXIDE 4%BellamiLuxx LLC532baae0-7e6f-1764-e063-6394a90a11ce2026-06-01WarningsExact identifier
application number: M006
Clean and Clear Acne Spot TreatmentSALICYLIC ACIDKenvue Brands LLC532c48d7-6d7b-ba96-e063-6394a90a9c302026-06-01WarningsExact identifier
application number: M006
SkinCeuticals Blemish Plus Age Defense Acne TreatmentSALICYLIC ACIDLOreal USA Products Inc727fa830-1f71-40ae-8153-7a29dbcb5e292026-06-01WarningsExact identifier
application number: M006
Hero Pore Release Blackhead ClearingSALICYLIC ACIDChurch & Dwight Co., Inc.436cf03c-3f74-4a02-bb0a-1d24f5c4fc292026-06-01WarningsExact identifier
application number: M006
Principal Secret Blemish Buster ClearSALICYLIC ACIDGuthy-Renker LLC75387738-eca2-4184-833b-95005eb276662026-05-29WarningsExact identifier
application number: M006
KUGIG ACNE TREATMENT SPRAYERSALICYLIC ACIDGuangdong Jiaoyu Biotechnology Co., Ltd.52b1e9cb-c083-a6eb-e063-6294a90ab6d12026-05-26WarningsExact identifier
application number: M006
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE BENZOYL PEROXIDE EFFACLAR BPOBENZOYL PEROXIDELOreal USA Products Inc851882ac-56f4-4bf6-b942-6efea10eec3e2026-05-26WarningsExact identifier
application number: M006
BLEMISH DOTS - RETINOL (10 PATCHES)SALICYLIC ACID 0.5%MELON BIO-TECH (THAILAND) CO., LTD.201eeecd-e759-42b8-b5c2-b19465d983322026-05-25WarningsExact identifier
application number: M006
BLEMISH DOTS - CHARCOAL (10 PATCHES)SALICYLIC ACID 0.5%MELON BIO-TECH (THAILAND) CO., LTD.a5431ecd-0afc-4525-9157-ee05ff752df52026-05-25WarningsExact identifier
application number: M006
XEXLVOV MILIA REMOVERSALICYLIC ACID 1% MILIA REMOVER LIQUIDShanghai Honghui Chuang Intelligent Technology Co., Ltd529bf32f-b40b-9602-e063-6294a90a1c2a2026-05-24WarningsExact 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