NDC 69509-001

Primo Topical Anesthetic

Benzocaine

Primo Topical Anesthetic is a Dental Gel in the Human Otc Drug category. It is labeled and distributed by Tri State Dental. The primary component is Benzocaine.

Product ID69509-001_c85377d9-f9a0-48a9-8197-30331c0d80f0
NDC69509-001
Product TypeHuman Otc Drug
Proprietary NamePrimo Topical Anesthetic
Generic NameBenzocaine
Dosage FormGel
Route of AdministrationDENTAL
Marketing Start Date2014-03-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameTri State Dental
Substance NameBENZOCAINE
Active Ingredient Strength200 mg/g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 69509-001-30

30 g in 1 JAR (69509-001-30)
Marketing Start Date2018-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69509-001-30 [69509000130]

Primo Topical Anesthetic GEL
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-11-01

Drug Details

Active Ingredients

IngredientStrength
BENZOCAINE200 mg/g

OpenFDA Data

SPL SET ID:c161da79-9ea5-4c7f-890c-4315129fe5bf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 238910

    • NDC Crossover Matching brand name "Primo Topical Anesthetic" or generic name "Benzocaine"

    NDCBrand NameGeneric Name
    69509-003Primo Topical AnestheticPrimo Topical Anesthetic
    69509-006Primo Topical AnestheticPrimo Topical Anesthetic
    69509-007Primo Topical AnestheticPrimo Topical Anesthetic
    69509-005Primo Topical AnestheticPrimo Topical Anesthetic
    69509-002Primo Topical AnestheticPrimo Topical Anesthetic
    69509-001Primo Topical AnestheticPrimo Topical Anesthetic
    69509-009Primo Topical AnestheticPrimo Topical Anesthetic
    69509-008Primo Topical AnestheticPrimo Topical Anesthetic
    69509-004Primo Topical AnestheticPrimo Topical Anesthetic
    0283-0220HurriCaineBenzocaine
    0283-0293HurriCaineBenzocaine
    0283-0520HurriCaineBenzocaine
    0283-0569HurriCaineBenzocaine
    0283-0679HurriCaineBenzocaine
    0283-0871HurriCaineBENZOCAINE
    0283-0886HurriCaineBenzocaine
    0283-0914HurriCaineBenzocaine
    0283-0920HurriCaineBenzocaine
    0283-0998HurriCaineBenzocaine
    0283-1016HurriCaineBENZOCAINE
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