NDC 57511-0122

Just Right 5000

1.1% Sodium Fluoride Toothpaste

Just Right 5000 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: 57511-0122_9005dbf5-1da5-bafb-e053-2995a90a0e50
• NDC: 57511-0122
• Product Type: Human Otc Drug
• Proprietary Name: Just Right 5000
• Generic Name: 1.1% Sodium Fluoride Toothpaste
• Dosage Form: Gel, Dentifrice
• Route of Administration: TOPICAL
• Marketing Start Date: 2020-01-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part355
• Labeler Name: Elevate Oral Care
• Substance Name: SODIUM FLUORIDE
• Active Ingredient Strength: 1 g/100g
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 57511-0122-8

97 g in 1 TUBE (57511-0122-8)

• Marketing Start Date: 2020-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 57511-0122-8 [57511012208]

Just Right 5000 GEL, DENTIFRICE

• Marketing Category: OTC monograph final
• Application Number: part355
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2020-01-01

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM FLUORIDE	1.1 g/100g

NDC Crossover Matching brand name "Just Right 5000" or generic name "1.1% Sodium Fluoride Toothpaste"

NDC	Brand Name	Generic Name
57511-0001	Just Right 5000	1.1% Sodium Fluoride Toothpaste
57511-0002	Just Right 5000	1.1% Sodium Fluoride Toothpaste
57511-0003	Just Right 5000	1.1% Sodium Fluoride Toothpaste
57511-0108	Just Right 5000	1.1% Sodium Fluoride Toothpaste
57511-0119	Just Right 5000	1.1% Sodium Fluoride Toothpaste
57511-0120	Just Right 5000	1.1% Sodium Fluoride Toothpaste
57511-0122	Just Right 5000	1.1% Sodium Fluoride Toothpaste
57511-0005	Allday 5000	1.1% Sodium Fluoride Toothpaste
57511-0101	FluoriMax 5000	1.1% Sodium Fluoride Toothpaste
57511-0504	FluoriMax 5000	1.1% Sodium Fluoride Toothpaste