Primo Topical Anesthetic

Product NDC
69509-004
11-digit product format
695090004
Labeler code
69509
Product ID
69509-004_2b36310d-0fcc-5e05-e063-6294a90a507b
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
69509-004-30Primo Topical Anesthetic30 g in 1 JARGEL304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69509-004PRIMO TOPICAL ANESTHETIC (BENZOCAINE) GEL [TRI STATE DENTAL]4Current NDC, Legacy NDC, 1 package rows20250110_f7862ee9-117a-493d-83ee-5aef588a86de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238910benzocaine 20 % Oral GelPSNf7862ee9-117a-493d-83ee-5aef588a86de4
238910benzocaine 0.2 MG/MG Oral GelSCDf7862ee9-117a-493d-83ee-5aef588a86de4
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSYf7862ee9-117a-493d-83ee-5aef588a86de4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69509-004-306950900043030 g in 1 JAR (69509-004-30) 30 g2018-11-010000-00-00NoNoCurrent