NDC 0135-0605

AQUAFRESH SENSITIVE MAXIMUM STRENGTH

Potassium Nitrate And Sodium Fluoride

AQUAFRESH SENSITIVE MAXIMUM STRENGTH is a Dental 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: 0135-0605_95747855-e293-425f-8e04-a3f7dfe22aa4
• NDC: 0135-0605
• Product Type: Human Otc Drug
• Proprietary Name: AQUAFRESH SENSITIVE MAXIMUM STRENGTH
• Generic Name: Potassium Nitrate And Sodium Fluoride
• Dosage Form: Paste
• Route of Administration: DENTAL
• Marketing Start Date: 2017-02-17
• 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: 2021-12-31

Packaging

NDC 0135-0605-01

1 TUBE in 1 CARTON (0135-0605-01) > 158.8 g in 1 TUBE

• Marketing Start Date: 2017-02-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0135-0605-01 [00135060501]

AQUAFRESH SENSITIVE MAXIMUM STRENGTH PASTE

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-02-17

Drug Details

Active Ingredients

Ingredient	Strength
POTASSIUM NITRATE	50 mg/g

OpenFDA Data

• SPL SET ID: 76adbccb-0812-4407-a6fc-a57e6f144fbb
• Manufacturer:
  • GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
• UNII:
  • RU45X2JN0Z
  • 8ZYQ1474W7
• RxNorm Concept Unique ID - RxCUI:
  • 1038841
  • 1038929

NDC Crossover Matching brand name "AQUAFRESH SENSITIVE MAXIMUM STRENGTH" or generic name "Potassium Nitrate And Sodium Fluoride"

NDC	Brand Name	Generic Name
0135-0605	AQUAFRESH SENSITIVE MAXIMUM STRENGTH	AQUAFRESH SENSITIVE MAXIMUM STRENGTH
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