NDC 53045-280

Ionite H

Sodium Fluoride, Potassium Nitrate

Ionite H is a Dental Gel, Dentifrice in the Human Prescription Drug category. It is labeled and distributed by Dharma Research, Inc.. The primary component is Sodium Fluoride; Potassium Nitrate.

• Product ID: 53045-280_0b21c890-82f5-4e90-8aa1-1e06d631760e
• NDC: 53045-280
• Product Type: Human Prescription Drug
• Proprietary Name: Ionite H
• Generic Name: Sodium Fluoride, Potassium Nitrate
• Dosage Form: Gel, Dentifrice
• Route of Administration: DENTAL
• Marketing Start Date: 2015-08-02
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Dharma Research, Inc.
• Substance Name: SODIUM FLUORIDE; POTASSIUM NITRATE
• Active Ingredient Strength: 1 mg/100g; mg/100g
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 53045-280-04

122 g in 1 TUBE (53045-280-04)

• Marketing Start Date: 2015-08-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53045-280-04 [53045028004]

Ionite H GEL, DENTIFRICE

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-08-02

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM FLUORIDE	1.1 mg/100g

OpenFDA Data

• SPL SET ID: 54c1a27c-5936-4ee2-a419-3891d3df9745
• Manufacturer:
  • Dharma Research, Inc.
• UNII:
  • RU45X2JN0Z
  • 8ZYQ1474W7
• RxNorm Concept Unique ID - RxCUI:
  • 637365

NDC Crossover Matching brand name "Ionite H" or generic name "Sodium Fluoride, Potassium Nitrate"

NDC	Brand Name	Generic Name
53045-270	Ionite H	Stannous Fluoride
53045-271	Ionite H	Stannous Fluoride
53045-275	Ionite H	Stannous Fluoride
53045-276	Ionite H	Stannous Fluoride
53045-280	Ionite H	Sodium Fluoride, Potassium Nitrate
53045-281	Ionite H	Sodium Fluoride, Potassium Nitrate
68983-006	iBrite	Sodium Fluoride, Potassium Nitrate
61596-437	MIPaste	sodium fluoride, potassium nitrate