NDC 57511-0124

Just Right

0.243% Sodium Fluoride Toothpaste

Just Right is a Topical Gel, Dentifrice in the Human Otc Drug category. It is labeled and distributed by Elevate Oral Care. The primary component is Sodium Fluoride.

• Product ID: 57511-0124_7f32d5ab-88f3-3001-e053-2991aa0a082e
• NDC: 57511-0124
• Product Type: Human Otc Drug
• Proprietary Name: Just Right
• Generic Name: 0.243% Sodium Fluoride Toothpaste
• Dosage Form: Gel, Dentifrice
• Route of Administration: TOPICAL
• Marketing Start Date: 2013-05-07
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part355
• Labeler Name: Elevate Oral Care
• Substance Name: SODIUM FLUORIDE
• Active Ingredient Strength: 0 g/100g
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 57511-0124-1

93.3 g in 1 TUBE (57511-0124-1)

• Marketing Start Date: 2013-05-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 57511-0124-1 [57511012401]

Just Right GEL, DENTIFRICE

• Marketing Category: OTC monograph final
• Application Number: part355
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-05-07

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM FLUORIDE	.243 g/100g

OpenFDA Data

• SPL SET ID: 530daec5-6306-43fb-b707-7a3cfd34f153
• Manufacturer:
  • Elevate Oral Care
• UNII:
  • 8ZYQ1474W7
• RxNorm Concept Unique ID - RxCUI:
  • 891775