NDC 35000-209

Colgate Enamel Health Mineral Repair

Potassium Nitrate And Sodium Fluoride

Colgate Enamel Health Mineral Repair is a Dental Paste, Dentifrice in the Human Otc Drug category. It is labeled and distributed by Colgate-palmolive Company. The primary component is Potassium Nitrate; Sodium Fluoride.

• Product ID: 35000-209_02a0f459-07ab-4cc6-8179-47e612a69800
• NDC: 35000-209
• Product Type: Human Otc Drug
• Proprietary Name: Colgate Enamel Health Mineral Repair
• Generic Name: Potassium Nitrate And Sodium Fluoride
• Dosage Form: Paste, Dentifrice
• Route of Administration: DENTAL
• Marketing Start Date: 2015-10-12
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part356
• Labeler Name: Colgate-Palmolive Company
• Substance Name: POTASSIUM NITRATE; SODIUM FLUORIDE
• Active Ingredient Strength: 50 mg/g; mg/g
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 35000-209-69

1 TUBE in 1 CARTON (35000-209-69) > 113 g in 1 TUBE

• Marketing Start Date: 2015-10-12
• Marketing End Date: 2021-12-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 35000-209-69 [35000020969]

Colgate Enamel Health Mineral Repair PASTE, DENTIFRICE

• Marketing Category: OTC MONOGRAPH NOT FINAL
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2015-10-12

Drug Details

Active Ingredients

Ingredient	Strength
POTASSIUM NITRATE	50 mg/g

OpenFDA Data

• SPL SET ID: 689d6a77-0608-411c-860b-8b2726be3438
• Manufacturer:
  • Colgate-Palmolive
• UNII:
  • RU45X2JN0Z
  • 8ZYQ1474W7
• RxNorm Concept Unique ID - RxCUI:
  • 1038929

NDC Crossover Matching brand name "Colgate Enamel Health Mineral Repair" or generic name "Potassium Nitrate And Sodium Fluoride"

NDC	Brand Name	Generic Name
35000-209	Colgate Enamel Health Mineral Repair	Colgate Enamel Health Mineral Repair
0135-0525	Sensodyne	potassium nitrate and sodium fluoride
0135-0526	Sensodyne	potassium nitrate and sodium fluoride
0135-0527	Sensodyne	potassium nitrate and sodium fluoride
0135-0528	Sensodyne	potassium nitrate and sodium fluoride
0135-0450	SENSODYNE PRONAMEL	potassium nitrate and sodium fluoride
0135-0460	SENSODYNE PRONAMEL	potassium nitrate and sodium fluoride
0135-0480	SENSODYNE PRONAMEL	potassium nitrate and sodium fluoride
0135-0481	SENSODYNE PRONAMEL	potassium nitrate and sodium fluoride
0135-0484	SENSODYNE PRONAMEL	potassium nitrate and sodium fluoride
0135-0486	SENSODYNE PRONAMEL	potassium nitrate and sodium fluoride
0135-0492	SENSODYNE PRONAMEL	potassium nitrate and sodium fluoride
0135-0520	SENSODYNE PRONAMEL	potassium nitrate and sodium fluoride