NDC 0135-0604

Aquafresh Extreme Clean Pure Breath Action

Sodium Fluoride

Aquafresh Extreme Clean Pure Breath Action 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 Sodium Fluoride.

• Product ID: 0135-0604_462eb309-deca-4464-b13a-7ae314e53ede
• NDC: 0135-0604
• Product Type: Human Otc Drug
• Proprietary Name: Aquafresh Extreme Clean Pure Breath Action
• Generic Name: Sodium Fluoride
• Dosage Form: Paste
• Route of Administration: DENTAL
• Marketing Start Date: 2016-06-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part355
• Labeler Name: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
• Substance Name: SODIUM FLUORIDE
• Active Ingredient Strength: 1 mg/g
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0135-0604-01

1 TUBE in 1 CARTON (0135-0604-01) > 158.8 g in 1 TUBE

• Marketing Start Date: 2016-06-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0135-0604-01 [00135060401]

Aquafresh Extreme Clean Pure Breath Action PASTE

• Marketing Category: OTC monograph final
• Application Number: part355
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-06-01

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM FLUORIDE	1.15 mg/g

OpenFDA Data

• SPL SET ID: 462eb309-deca-4464-b13a-7ae314e53ede
• Manufacturer:
  • GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
• UNII:
  • 8ZYQ1474W7
• RxNorm Concept Unique ID - RxCUI:
  • 1044547

NDC Crossover Matching brand name "Aquafresh Extreme Clean Pure Breath Action" or generic name "Sodium Fluoride"

NDC	Brand Name	Generic Name
0135-0604	Aquafresh Extreme Clean Pure Breath Action	Aquafresh Extreme Clean Pure Breath Action
0135-0234	AQUAFRESH	sodium fluoride
0126-0021	Colgate	SODIUM FLUORIDE
0126-0034	Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride	SODIUM FLUORIDE
0126-0032	Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Mint Fluoride	SODIUM FLUORIDE
0041-1421	Oral-B	Sodium Fluoride
0126-0131	Phos-Flur	Sodium Fluoride
0126-0135	Phos-Flur Ortho Defense	SODIUM FLUORIDE
0126-0138	Phos-Flur Ortho Defense	SODIUM FLUORIDE
0126-0139	Phos-Flur Ortho Defense	SODIUM FLUORIDE
0126-0074	PrevidDent 5000 Booster Plus Spearmint	Sodium Fluoride
0126-0016	PreviDent	Sodium fluoride
0126-0075	PreviDent	Sodium fluoride
0126-0076	PreviDent	Sodium fluoride
0126-0179	PreviDent	Sodium Fluoride
0126-0286	PreviDent	Sodium Fluoride
0126-0287	PreviDent	Sodium Fluoride
0126-0072	PreviDent 5000 Booster Plus Fruitastic	Sodium Fluoride
0126-0033	PreviDent Alcohol Free	Sodium Fluoride
0126-0088	PreviDent Fresh Mint	Sodium Fluoride
0126-0289	PreviDent OrthoDefense	SODIUM FLUORIDE
0126-0288	PreviDent Very Berry	Sodium Fluoride