NDC 0135-0486

SENSODYNE PRONAMEL Intensive Enamel Repair Extra Fresh

Potassium Nitrate And Sodium Fluoride

SENSODYNE PRONAMEL Intensive Enamel Repair Extra Fresh is a Oral Paste in the Human Otc Drug category. It is labeled and distributed by Glaxosmithkline Consumer Healthcare Holdings (us). The primary component is Potassium Nitrate; Sodium Fluoride.

• Product ID: 0135-0486_770c2c23-3f4e-4209-93c0-315691daea5b
• NDC: 0135-0486
• Product Type: Human Otc Drug
• Proprietary Name: SENSODYNE PRONAMEL Intensive Enamel Repair Extra Fresh
• Generic Name: Potassium Nitrate And Sodium Fluoride
• Dosage Form: Paste
• Route of Administration: ORAL
• Marketing Start Date: 2018-11-29
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part356
• Labeler Name: GlaxoSmithKline Consumer Healthcare Holdings (US)
• Substance Name: POTASSIUM NITRATE; SODIUM FLUORIDE
• Active Ingredient Strength: 50 mg/g; mg/g
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0135-0486-01

1 TUBE in 1 CARTON (0135-0486-01) > 96.4 g in 1 TUBE

• Marketing Start Date: 2018-11-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0135-0486-01 [00135048601]

SENSODYNE PRONAMEL Intensive Enamel Repair Extra Fresh PASTE

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2018-11-29

NDC 0135-0486-02 [00135048602]

SENSODYNE PRONAMEL Intensive Enamel Repair Extra Fresh PASTE

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2020-01-06

Drug Details

Active Ingredients

Ingredient	Strength
POTASSIUM NITRATE	50 mg/g

OpenFDA Data

• SPL SET ID: a2f9d58b-671b-4427-a971-1fceff5f2323
• Manufacturer:
  • GlaxoSmithKline Consumer Healthcare Holdings (US)
• UNII:
  • RU45X2JN0Z
  • 8ZYQ1474W7
• RxNorm Concept Unique ID - RxCUI:
  • 1086243

NDC Crossover Matching brand name "SENSODYNE PRONAMEL Intensive Enamel Repair Extra Fresh" or generic name "Potassium Nitrate And Sodium Fluoride"

NDC	Brand Name	Generic Name
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