NDC 53045-135

Iolite

Benzocaine

Iolite is a Dental; Oral Gel in the Human Otc Drug category. It is labeled and distributed by Dharma Research, Inc.. The primary component is Benzocaine.

• Product ID: 53045-135_a70ab992-8c43-4cfb-91d8-49b513cb06b7
• NDC: 53045-135
• Product Type: Human Otc Drug
• Proprietary Name: Iolite
• Generic Name: Benzocaine
• Dosage Form: Gel
• Route of Administration: DENTAL; ORAL
• Marketing Start Date: 2017-07-23
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part356
• Labeler Name: Dharma Research, Inc.
• Substance Name: BENZOCAINE
• Active Ingredient Strength: 6 g/100g
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 53045-135-30

32 g in 1 BOTTLE (53045-135-30)

• Marketing Start Date: 2017-07-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53045-135-30 [53045013530]

Iolite GEL

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-07-23

Drug Details

Active Ingredients

Ingredient	Strength
BENZOCAINE	6.4 g/100g

OpenFDA Data

• SPL SET ID: db763237-2910-45b9-be72-da092edc951b
• Manufacturer:
  • Dharma Research, Inc.
• UNII:
  • U3RSY48JW5

NDC Crossover Matching brand name "Iolite" or generic name "Benzocaine"

NDC	Brand Name	Generic Name
53045-131	Iolite	Iolite
53045-132	Iolite	Iolite
53045-135	Iolite	Iolite
53045-136	Iolite	Iolite
53045-130	Iolite	Iolite
53045-133	Iolite	Iolite
53045-134	Iolite	Iolite
53045-138	Iolite	Iolite
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