NDC 61509-104

Mark 3

Benzocaine

Mark 3 is a Dental; Oral Gel in the Human Otc Drug category. It is labeled and distributed by Cargus International, Inc.. The primary component is Benzocaine.

• Product ID: 61509-104_7a0b280c-71fb-4924-b522-f3db6db92696
• NDC: 61509-104
• Product Type: Human Otc Drug
• Proprietary Name: Mark 3
• Generic Name: Benzocaine
• Dosage Form: Gel
• Route of Administration: DENTAL; ORAL
• Marketing Start Date: 2014-03-03
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part356
• Labeler Name: Cargus International, Inc.
• Substance Name: BENZOCAINE
• Active Ingredient Strength: 6 g/32g
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 61509-104-32

32 g in 1 BOTTLE (61509-104-32)

• Marketing Start Date: 2021-03-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61509-104-32 [61509010432]

Mark 3 GEL

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2014-03-03
• Inactivation Date: 2019-11-27

Drug Details

Active Ingredients

Ingredient	Strength
BENZOCAINE	6.4 g/32g

OpenFDA Data

• SPL SET ID: d65bc785-aafc-4f4c-860b-890fb59b552e
• Manufacturer:
  • Cargus International, Inc.
• UNII:
  • U3RSY48JW5
• RxNorm Concept Unique ID - RxCUI:
  • 238910

NDC Crossover Matching brand name "Mark 3" or generic name "Benzocaine"

NDC	Brand Name	Generic Name
61509-104	Mark 3	Mark 3
61509-105	Mark 3	Mark 3
61509-109	Mark 3	Mark 3
61509-102	Mark 3	Mark 3
61509-107	Mark 3	Mark 3
61509-106	Mark 3	Mark 3
61509-103	Mark 3	Mark 3
61509-108	Mark 3	Mark 3
61509-101	Mark 3	Mark 3
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