Astra-dent Topical Anesthetic Gel

Product NDC
71363-107
11-digit product format
713630107
Labeler code
71363
Product ID
71363-107_2b4802d3-e19f-3d39-e063-6294a90ae6bb
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
GEL
Route
DENTAL
Labeler
Zag Usa Inc
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-07-01
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
Astra-dent Topical Anesthetic Gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE200 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3RSY48JW5
Rxcui238910

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71363-107-30Astra-dent Topical Anesthetic Gel28 g in 1 JARGEL284

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71363-107ASTRA-DENT TOPICAL ANESTHETIC GEL (BENZOCAINE) GEL [ZAG USA INC]4Current NDC, Legacy NDC, 1 package rows20250112_f71b0ab5-0605-4807-b835-903e19aaf2a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238910benzocaine 20 % Oral GelPSNf71b0ab5-0605-4807-b835-903e19aaf2a84
238910benzocaine 0.2 MG/MG Oral GelSCDf71b0ab5-0605-4807-b835-903e19aaf2a84
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSYf71b0ab5-0605-4807-b835-903e19aaf2a84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71363-107-307136301073028 g in 1 JAR (71363-107-30) 28 g2018-08-010000-00-00NoNoCurrent