NDC 69509-003

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 ID: 69509-003_60880bbe-2e4b-4ff8-91a5-9f247f55d2da
• NDC: 69509-003
• Product Type: Human Otc Drug
• Proprietary Name: Primo Topical Anesthetic
• Generic Name: Benzocaine
• Dosage Form: Gel
• Route of Administration: DENTAL
• Marketing Start Date: 2014-03-01
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part356
• Labeler Name: Tri State Dental
• Substance Name: BENZOCAINE
• Active Ingredient Strength: 200 mg/g
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 69509-003-30

30 g in 1 JAR (69509-003-30)

• Marketing Start Date: 2018-11-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69509-003-30 [69509000330]

Primo Topical Anesthetic GEL

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2018-11-01

Drug Details

Active Ingredients

Ingredient	Strength
BENZOCAINE	200 mg/g

OpenFDA Data

• SPL SET ID: 45422b0f-f1ac-4bec-851a-c1394bc52fcc
• Manufacturer:
  • Tri State Dental
• UNII:
  • U3RSY48JW5
• RxNorm Concept Unique ID - RxCUI:
  • 238910

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

NDC	Brand Name	Generic Name
69509-003	Primo Topical Anesthetic	Primo Topical Anesthetic
69509-006	Primo Topical Anesthetic	Primo Topical Anesthetic
69509-007	Primo Topical Anesthetic	Primo Topical Anesthetic
69509-005	Primo Topical Anesthetic	Primo Topical Anesthetic
69509-002	Primo Topical Anesthetic	Primo Topical Anesthetic
69509-001	Primo Topical Anesthetic	Primo Topical Anesthetic
69509-009	Primo Topical Anesthetic	Primo Topical Anesthetic
69509-008	Primo Topical Anesthetic	Primo Topical Anesthetic
69509-004	Primo Topical Anesthetic	Primo Topical Anesthetic
0283-0220	HurriCaine	Benzocaine
0283-0293	HurriCaine	Benzocaine
0283-0520	HurriCaine	Benzocaine
0283-0569	HurriCaine	Benzocaine
0283-0679	HurriCaine	Benzocaine
0283-0871	HurriCaine	BENZOCAINE
0283-0886	HurriCaine	Benzocaine
0283-0914	HurriCaine	Benzocaine
0283-0920	HurriCaine	Benzocaine
0283-0998	HurriCaine	Benzocaine
0283-1016	HurriCaine	BENZOCAINE