NDC 64522-004

VistaCaine Topical Anesthetic

Benzocaine

VistaCaine Topical Anesthetic is a Dental Gel in the Human Otc Drug category. It is labeled and distributed by Inter-med, Inc.. The primary component is Benzocaine.

• Product ID: 64522-004_d658d6c6-e004-5083-e053-2a95a90a1a1f
• NDC: 64522-004
• Product Type: Human Otc Drug
• Proprietary Name: VistaCaine Topical Anesthetic
• Generic Name: Benzocaine
• Dosage Form: Gel
• Route of Administration: DENTAL
• Marketing Start Date: 2018-02-01
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part356
• Labeler Name: Inter-Med, INC.
• Substance Name: BENZOCAINE
• Active Ingredient Strength: 200 mg/g
• Pharm Classes: Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 64522-004-30

30 g in 1 JAR (64522-004-30)

• Marketing Start Date: 2018-02-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 64522-004-30 [64522000430]

VistaCaine Topical Anesthetic GEL

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2018-02-01

Drug Details

Active Ingredients

Ingredient	Strength
BENZOCAINE	200 mg/g

OpenFDA Data

• SPL SET ID: 632c9ed0-3b9b-4fa8-817e-c4ac7e21ad59
• Manufacturer:
  • Inter-Med, INC.
• UNII:
  • U3RSY48JW5
• RxNorm Concept Unique ID - RxCUI:
  • 238910
  • 2002727

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

NDC	Brand Name	Generic Name
64522-001	VistaCaine Topical Anesthetic	VistaCaine Topical Anesthetic
64522-002	VistaCaine Topical Anesthetic	VistaCaine Topical Anesthetic
64522-003	VistaCaine Topical Anesthetic	VistaCaine Topical Anesthetic
64522-004	VistaCaine Topical Anesthetic	VistaCaine 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