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 50 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vichy Laboratoires Normaderm SOS Acne Rescue Spot CorrectorSULFURL'Oreal USA Products Inc4907bc52-62e3-4256-b4ca-bcde896a4aab2023-12-27WarningsExact identifier
application number: M006
Thayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Formula PadsSALICYLIC ACIDL'Oreal USA Products Incbc0d1691-c13d-4c15-8c44-ecee30cb0ae22023-12-27WarningsExact identifier
application number: M006
Thayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Formula CleanserSALICYLIC ACIDL'Oreal USA Products Inc935a58f0-d9a3-4423-9a5f-65fd19fad3db2023-12-27WarningsExact identifier
application number: M006
All Acne TreatmentSALICYLIC ACIDBlaine Labs Inc.ee85939e-64fc-4b18-af5b-6ebd7e14e5722023-12-21WarningsExact identifier
application number: M006
In the Clear Acne SerumSALICYLIC ACIDThe Honest Company, Incdc9e0545-43af-3d27-e053-2a95a90a52492023-12-19WarningsExact identifier
application number: M006
Spot Stopper Acne Spot TreatmentSALICYLIC ACIDThe Honest Company, Incdc7afebd-e212-b9ff-e053-2a95a90a15a52023-12-19WarningsExact identifier
application number: M006
Get Clarity Foaming Acne CleanserSULFURThe Honest Company, Incdd948b1b-d71c-1a89-e053-2a95a90a87192023-12-19WarningsExact identifier
application number: M006
Acne Med 10%BENZOYL PEROXIDEFace Reality, LLC45ad7429-ccd0-28f6-e054-00144ff88e882023-12-15WarningsExact identifier
application number: M006
Acne Face and BodyBENZOYL PEROXIDEFace Reality, Inc.454983d2-4b00-6268-e054-00144ff8d46c2023-12-15WarningsExact identifier
application number: M006
Acne Med 5%BENZOYL PEROXIDEFace Reality, LLC454983d2-4b11-6268-e054-00144ff8d46c2023-12-15WarningsExact identifier
application number: M006
Acne Face and Body WashBENZOYL PEROXIDEFace Reality Skin Care, LLC454983d2-4aec-6268-e054-00144ff8d46c2023-12-15WarningsExact identifier
application number: M006
Acne Med 2.5%BENZOYL PEROXIDEFace Reality, LLC454983d2-4b0f-6268-e054-00144ff8d46c2023-12-15WarningsExact identifier
application number: M006
Nighttime ControlBENZOYL PEROXIDECircadia by Dr Pugliese, Inc.fb4cc832-4cfd-4e29-a78e-ab848681a2242023-12-15WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar Pore Refining Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Inc5056320e-e472-44ed-9afd-759ba55f0fd72023-12-13WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar AntiAcne Pore Refining Acne TreatmentSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTION418d480c-4131-4262-bb56-d5b10bbf7dcb2023-12-13WarningsExact identifier
application number: M006
Acne Advanced Clarifying MasqueSALICYLIC ACIDEminence Organic Skin Care Ltd.7916a299-fc90-4eb7-882f-4caa39e2c7aa2023-12-12WarningsExact identifier
application number: M006
Serious Skincare Continuously Clear Acne Medication For Problematic skin Dry Lo Pro All- Over TreatmentSALICYLIC ACIDFlageoli Limitedeb57517c-cf9e-4272-9c00-380385f916e02023-12-12WarningsExact identifier
application number: M006
111MedCo 6% Sulfur Skin Cleansing BarSULFUR111MedCo LLC7a2d647f-f10f-4637-b28b-319fed93677b2023-12-12WarningsExact identifier
application number: M006
111MedCo 2% Salicylic Acid Cleansing BarSALICYLIC ACID111MedCo LLC6ba7dd8f-b59f-4dfb-b55e-c7fe65a54d8a2023-12-12WarningsExact identifier
application number: M006
111 Medco Benzoyl PeroxideBENZOYL PEROXIDE111 Medco8590214e-e5a7-8934-e053-2a91aa0a248b2023-12-12WarningsExact 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