Benzo-Jel

Product NDC
0404-0033
11-digit product format
004040033
Labeler code
0404
Product ID
0404-0033_2acfde41-0b79-ccba-e063-6294a90ac911
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
GEL
Route
DENTAL
Labeler
Henry Schein Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-05-01
Substance
BENZOCAINE
Active strength
200 mg/g
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
BENZOCAINE200 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3RSY48JW5
Rxcui238910, 1053444

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-0033-30Benzo-Jel30 g in 1 JARGEL304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-0033BENZO-JEL (BENZOCAINE) GEL [HENRY SCHEIN INC.]4Current NDC, Legacy NDC, 1 package rows20250105_fb38b10d-0faf-403c-9921-d4f6b0f6aa55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053444BENZO-JEL 20 % Oral GelPSNfb38b10d-0faf-403c-9921-d4f6b0f6aa554
238910benzocaine 20 % Oral GelPSNfb38b10d-0faf-403c-9921-d4f6b0f6aa554
1053444benzocaine 0.2 MG/MG Oral Gel [Benzo-Jel]SBDfb38b10d-0faf-403c-9921-d4f6b0f6aa554
238910benzocaine 0.2 MG/MG Oral GelSCDfb38b10d-0faf-403c-9921-d4f6b0f6aa554
1053444Benzo-Jel 0.2 MG/MG Oral GelSYfb38b10d-0faf-403c-9921-d4f6b0f6aa554
1053444Benzo-Jel 20 % Oral GelSYfb38b10d-0faf-403c-9921-d4f6b0f6aa554
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSYfb38b10d-0faf-403c-9921-d4f6b0f6aa554

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0404-0033-300040400333030 g in 1 JAR (0404-0033-30) 30 g2018-06-010000-00-00NoNoCurrent