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

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 Identifiers#

Field, Values table
FieldValues
UniiU3RSY48JW5
Rxcui360348, 1742420

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

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