NDC 61596-437

MIPaste ONE

Sodium Fluoride, Potassium Nitrate

MIPaste ONE is a Dental Paste, Dentifrice in the Human Otc Drug category. It is labeled and distributed by Gc America Inc.. The primary component is Sodium Fluoride; Potassium Nitrate.

• Product ID: 61596-437_791349a6-e9db-214e-e053-2991aa0adff4
• NDC: 61596-437
• Product Type: Human Otc Drug
• Proprietary Name: MIPaste ONE
• Generic Name: Sodium Fluoride, Potassium Nitrate
• Dosage Form: Paste, Dentifrice
• Route of Administration: DENTAL
• Marketing Start Date: 2017-07-03
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part356
• Labeler Name: GC America Inc.
• Substance Name: SODIUM FLUORIDE; POTASSIUM NITRATE
• Active Ingredient Strength: 0 g/g; g/g
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 61596-437-41

1 TUBE in 1 BOX (61596-437-41) > 46 g in 1 TUBE (61596-437-40)

• Marketing Start Date: 2017-07-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61596-437-41 [61596043741]

MIPaste ONE PASTE, DENTIFRICE

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-07-03

NDC 61596-437-40 [61596043740]

MIPaste ONE PASTE, DENTIFRICE

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-07-03

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM FLUORIDE	.0024 g/g

OpenFDA Data

• SPL SET ID: 4d63020f-934c-2af4-e054-00144ff8d46c
• Manufacturer:
  • GC America Inc.
• UNII:
  • RU45X2JN0Z
  • 8ZYQ1474W7

NDC Crossover Matching brand name "MIPaste ONE" or generic name "Sodium Fluoride, Potassium Nitrate"

NDC	Brand Name	Generic Name
61596-400	MIPaste One	MIPaste One
68983-006	iBrite	Sodium Fluoride, Potassium Nitrate
53045-280	Ionite H	Sodium Fluoride, Potassium Nitrate
53045-281	Ionite H	Sodium Fluoride, Potassium Nitrate
61596-437	MIPaste	sodium fluoride, potassium nitrate