Primo Topical Anesthetic

Product NDC
69509-009
11-digit product format
695090009
Labeler code
69509
Product ID
69509-009_2b378448-aa45-cffe-e063-6394a90a44c3
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
GEL
Route
DENTAL
Labeler
Tri State Dental
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-03-01
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
Primo Topical Anesthetic
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
69509-009-30Primo Topical Anesthetic30 g in 1 JARGEL304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69509-009PRIMO TOPICAL ANESTHETIC (BENZOCAINE) GEL [TRI STATE DENTAL]4Current NDC, Legacy NDC, 1 package rows20250110_f5d37a12-9db1-4f2c-9dd1-72a8361e0e57.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238910benzocaine 20 % Oral GelPSNf5d37a12-9db1-4f2c-9dd1-72a8361e0e574
238910benzocaine 0.2 MG/MG Oral GelSCDf5d37a12-9db1-4f2c-9dd1-72a8361e0e574
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSYf5d37a12-9db1-4f2c-9dd1-72a8361e0e574

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69509-009-306950900093030 g in 1 JAR (69509-009-30) 30 g2018-11-010000-00-00NoNoCurrent