NDC 57511-0102

FluoriMax 5000 Sensitive

1.1% Sodium Fluoride With 5% Potassium Nitrate Toothpaste

FluoriMax 5000 Sensitive is a Topical Paste, Dentifrice in the Human Otc Drug category. It is labeled and distributed by Elevate Oral Care. The primary component is Potassium Nitrate; Sodium Fluoride.

• Product ID: 57511-0102_728d0443-e02b-6737-e053-2a91aa0aa80f
• NDC: 57511-0102
• Product Type: Human Otc Drug
• Proprietary Name: FluoriMax 5000 Sensitive
• Generic Name: 1.1% Sodium Fluoride With 5% Potassium Nitrate Toothpaste
• Dosage Form: Paste, Dentifrice
• Route of Administration: TOPICAL
• Marketing Start Date: 2017-08-01
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Elevate Oral Care
• Substance Name: POTASSIUM NITRATE; SODIUM FLUORIDE
• Active Ingredient Strength: 5 g/100g; g/100g
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 57511-0102-3

96 g in 1 TUBE (57511-0102-3)

• Marketing Start Date: 2017-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 57511-0102-3 [57511010203]

FluoriMax 5000 Sensitive PASTE, DENTIFRICE

• Marketing Category: unapproved drug other
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-08-01

Drug Details

Active Ingredients

Ingredient	Strength
POTASSIUM NITRATE	5 g/100g

OpenFDA Data

• SPL SET ID: 53bdd864-40e7-4d22-e054-00144ff88e88
• Manufacturer:
  • Elevate Oral Care
• UNII:
  • RU45X2JN0Z
  • 8ZYQ1474W7
• RxNorm Concept Unique ID - RxCUI:
  • 637365

NDC Crossover Matching brand name "FluoriMax 5000 Sensitive" or generic name "1.1% Sodium Fluoride With 5% Potassium Nitrate Toothpaste"

NDC	Brand Name	Generic Name
57511-0102	FluoriMax 5000 Sensitive	1.1% Sodium Fluoride with 5% Potassium Nitrate Toothpaste
57511-0503	FluoriMax 5000 Sensitive	1.1% Sodium Fluoride with 5% Potassium Nitrate Toothpaste