Primo Topical Anesthetic

Product NDC
69509-003
11-digit product format
695090003
Labeler code
69509
Product ID
69509-003_2b363395-43e2-3aee-e063-6294a90a4e89
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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69509-003-30Primo Topical Anesthetic30 g in 1 JARGEL304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69509-003PRIMO TOPICAL ANESTHETIC (BENZOCAINE) GEL [TRI STATE DENTAL]4Current NDC, Legacy NDC, 1 package rows20250110_45422b0f-f1ac-4bec-851a-c1394bc52fcc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238910benzocaine 20 % Oral GelPSN45422b0f-f1ac-4bec-851a-c1394bc52fcc4
238910benzocaine 0.2 MG/MG Oral GelSCD45422b0f-f1ac-4bec-851a-c1394bc52fcc4
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY45422b0f-f1ac-4bec-851a-c1394bc52fcc4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69509-003-306950900033030 g in 1 JAR (69509-003-30) 30 g2018-11-010000-00-00NoNoCurrent