NDC 0126-0022

PreviDent 5000 Enamel Protect

Sodium Fluoride And Potassium Nitrate

PreviDent 5000 Enamel Protect is a Dental Gel, Dentifrice in the Human Prescription Drug category. It is labeled and distributed by Colgate Oral Pharmaceuticals, Inc.. The primary component is Potassium Nitrate; Sodium Fluoride.

• Product ID: 0126-0022_6b3ab11f-e5c3-460b-8519-1214876dd629
• NDC: 0126-0022
• Product Type: Human Prescription Drug
• Proprietary Name: PreviDent 5000 Enamel Protect
• Generic Name: Sodium Fluoride And Potassium Nitrate
• Dosage Form: Gel, Dentifrice
• Route of Administration: DENTAL
• Marketing Start Date: 2011-03-30
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Colgate Oral Pharmaceuticals, Inc.
• Substance Name: POTASSIUM NITRATE; SODIUM FLUORIDE
• Active Ingredient Strength: 58 mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0126-0022-92

100 mL in 1 BOTTLE (0126-0022-92)

• Marketing Start Date: 2011-03-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0126-0022-12 [00126002212]

PreviDent 5000 Enamel Protect GEL, DENTIFRICE

• Marketing Category: UNAPPROVED DRUG OTHER
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-03-30

NDC 0126-0022-92 [00126002292]

PreviDent 5000 Enamel Protect GEL, DENTIFRICE

• Marketing Category: UNAPPROVED DRUG OTHER
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2011-03-30

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM FLUORIDE	5.8 mg/mL

OpenFDA Data

• SPL SET ID: bbc66b1b-e05c-4e14-bef3-b8bae419fc89
• Manufacturer:
  • Colgate Oral Pharmaceuticals, Inc.
• UNII:
  • RU45X2JN0Z
  • 8ZYQ1474W7
• UPC Code:
  • 0301260022925

NDC Crossover Matching brand name "PreviDent 5000 Enamel Protect" or generic name "Sodium Fluoride And Potassium Nitrate"

NDC	Brand Name	Generic Name
0126-0022	PreviDent 5000 Enamel Protect	SODIUM FLUORIDE and POTASSIUM NITRATE
61649-733	BIO SPECTRA	Sodium fluoride and Potassium nitrate
35000-928	Colgate	SODIUM FLUORIDE and POTASSIUM NITRATE
65954-044	Colgate	SODIUM FLUORIDE and POTASSIUM NITRATE
65954-358	Colgate	SODIUM FLUORIDE and POTASSIUM NITRATE
35000-948	Colgate Advanced Sensitive Plus Whitening	SODIUM FLUORIDE and POTASSIUM NITRATE
65954-580	Colgate Advanced Sensitive Plus Whitening	SODIUM FLUORIDE and POTASSIUM NITRATE
35000-965	Colgate Sensitive Complete Protection	SODIUM FLUORIDE and POTASSIUM NITRATE
65954-773	Colgate Sensitive Complete Protection	SODIUM FLUORIDE and POTASSIUM NITRATE
35000-968	Colgate Sensitive Maximum Strength Mint Clean	SODIUM FLUORIDE and POTASSIUM NITRATE
65954-776	Colgate Sensitive Maximum Strength Mint Clean	SODIUM FLUORIDE and POTASSIUM NITRATE
35000-910	Colgate Sensitive Multiprotection	SODIUM FLUORIDE and POTASSIUM NITRATE
65954-046	Colgate Sensitive Multiprotection	SODIUM FLUORIDE and POTASSIUM NITRATE
35000-962	Colgate Sensitive Prevent and Repair	SODIUM FLUORIDE and POTASSIUM NITRATE
65954-770	Colgate Sensitive Prevent and Repair	SODIUM FLUORIDE and POTASSIUM NITRATE
35000-944	Colgate Sensitive Pro Relief	SODIUM FLUORIDE and POTASSIUM NITRATE
65954-549	Colgate Sensitive Pro Relief	SODIUM FLUORIDE and POTASSIUM NITRATE
35000-943	Colgate Sensitive Pro Relief Whitening	SODIUM FLUORIDE and POTASSIUM NITRATE
65954-548	Colgate Sensitive Pro Relief Whitening	SODIUM FLUORIDE and POTASSIUM NITRATE
35000-992	Colgate Ultra Relief	SODIUM FLUORIDE and POTASSIUM NITRATE
37000-849	Crest	Sodium Fluoride and Potassium Nitrate
37000-995	Crest Premium Plus	Sodium Fluoride and Potassium Nitrate
37000-374	Crest Pro Health Sensitivity	Sodium Fluoride and Potassium Nitrate
37000-898	Crest Sensitivity	Sodium Fluoride and Potassium Nitrate
51009-166	Maximum Strength Sensitive	Sodium Fluoride and Potassium Nitrate
51009-167	Maximum Strength Sensitive	Sodium Fluoride and Potassium Nitrate
0126-0070	PreviDent	Sodium fluoride and Potassium nitrate
69367-318	Sodium Fluoride and Potassium Nitrate	Sodium Fluoride and Potassium Nitrate