NDC 0135-0603

Sensodyne Pronamel Strong and Bright Enamel Extra Fresh

Potassium Nitrate And Sodium Fluoride

Sensodyne Pronamel Strong and Bright Enamel Extra Fresh is a Oral Paste in the Human Otc Drug category. It is labeled and distributed by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The primary component is Potassium Nitrate; Sodium Fluoride.

• Product ID: 0135-0603_12961035-ae7c-47f0-9190-46a212718152
• NDC: 0135-0603
• Product Type: Human Otc Drug
• Proprietary Name: Sensodyne Pronamel Strong and Bright Enamel Extra Fresh
• Generic Name: Potassium Nitrate And Sodium Fluoride
• Dosage Form: Paste
• Route of Administration: ORAL
• Marketing Start Date: 2016-12-19
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part356
• Labeler Name: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
• Substance Name: POTASSIUM NITRATE; SODIUM FLUORIDE
• Active Ingredient Strength: 50 mg/g; mg/g
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0135-0603-01

1 TUBE in 1 CARTON (0135-0603-01) > 85 g in 1 TUBE

• Marketing Start Date: 2016-12-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0135-0603-01 [00135060301]

Sensodyne Pronamel Strong and Bright Enamel Extra Fresh PASTE

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Billing Unit: GM
• Marketing Start Date: 2016-12-19

Drug Details

Active Ingredients

Ingredient	Strength
POTASSIUM NITRATE	50 mg/g

OpenFDA Data

• SPL SET ID: be1ae382-0e01-4db8-90d7-fdadec2ff861
• Manufacturer:
  • GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
• UNII:
  • RU45X2JN0Z
  • 8ZYQ1474W7
• RxNorm Concept Unique ID - RxCUI:
  • 1086243

NDC Crossover Matching brand name "Sensodyne Pronamel Strong and Bright Enamel Extra Fresh" or generic name "Potassium Nitrate And Sodium Fluoride"

NDC	Brand Name	Generic Name
0135-0603	Sensodyne Pronamel Strong and Bright Enamel Extra Fresh	Sensodyne Pronamel Strong and Bright Enamel Extra Fresh
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