NDC 0699-3112

Topex Pina Colada

Benzocaine

Topex Pina Colada is a Dental Gel in the Human Prescription Drug category. It is labeled and distributed by Dentsply Llc. Professional Division Trading As "sultan Healthcare". The primary component is Benzocaine.

• Product ID: 0699-3112_60cbe11b-eefd-448a-e053-2991aa0a2d09
• NDC: 0699-3112
• Product Type: Human Prescription Drug
• Proprietary Name: Topex Pina Colada
• Generic Name: Benzocaine
• Dosage Form: Gel
• Route of Administration: DENTAL
• Marketing Start Date: 1900-01-01
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Dentsply LLC. Professional Division Trading as "Sultan Healthcare"
• Substance Name: BENZOCAINE
• Active Ingredient Strength: 220 mg/g
• Pharm Classes: Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0699-3112-12

120 DOSE PACK in 1 CARTON (0699-3112-12) > .4 g in 1 DOSE PACK

• Marketing Start Date: 1900-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0699-3112-12 [00699311212]

Topex Pina Colada GEL

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1900-01-01

NDC 0699-3112-24 [00699311224]

Topex Pina Colada GEL

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1900-01-01

Drug Details

Active Ingredients

Ingredient	Strength
BENZOCAINE	220 mg/g

OpenFDA Data

• SPL SET ID: 60cbe11b-eefc-448a-e053-2991aa0a2d09
• Manufacturer:
  • Dentsply LLC. Professional Division Trading as "Sultan Healthcare"
• UNII:
  • U3RSY48JW5

Pharmacological Class

• Standardized Chemical Allergen [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Allergens [CS]
• Standardized Chemical Allergen [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Allergens [CS]

NDC Crossover Matching brand name "Topex Pina Colada" or generic name "Benzocaine"

NDC	Brand Name	Generic Name
0699-7091	Topex Pina Colada	Topex Pina Colada
0699-7001	Topex Pina Colada	Topex Pina Colada
0699-3112	Topex Pina Colada	Topex Pina Colada
10216-3091	Topex Pina Colada	Topex Pina Colada
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