NDC 10216-3081

Topex Mint

Benzocaine

Topex Mint is a Dental Gel, Dentifrice in the Human Prescription Drug category. It is labeled and distributed by Dentsply Caulk. The primary component is Benzocaine.

• Product ID: 10216-3081_983a1364-6118-4d7e-9b80-5011306c0b7d
• NDC: 10216-3081
• Product Type: Human Prescription Drug
• Proprietary Name: Topex Mint
• Generic Name: Benzocaine
• Dosage Form: Gel, Dentifrice
• Route of Administration: DENTAL
• Marketing Start Date: 1963-02-19
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: DENTSPLY Caulk
• 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: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 10216-3081-1

100 g in 1 JAR (10216-3081-1)

• Marketing Start Date: 1963-02-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10216-3081-1 [10216308101]

Topex Mint GEL, DENTIFRICE

• Marketing Category: UNAPPROVED DRUG OTHER
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1963-02-19
• Inactivation Date: 2019-10-21

Drug Details

Active Ingredients

Ingredient	Strength
BENZOCAINE	220 mg/g

OpenFDA Data

• SPL SET ID: db4f2105-9e47-45b6-b550-6397708eb335
• Manufacturer:
  • DENTSPLY Caulk
• UNII:
  • U3RSY48JW5
• RxNorm Concept Unique ID - RxCUI:
  • 238910

Pharmacological Class

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

NDC Crossover Matching brand name "Topex Mint" or generic name "Benzocaine"

NDC	Brand Name	Generic Name
0699-7081	Topex Mint	Topex Mint
0699-7011	Topex Mint	Topex Mint
10216-3081	Topex Mint	Topex Mint
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