NDC 70810-001

Pro Brighten Tooth whitening Gel

Hydrogen Peroxide

Pro Brighten Tooth whitening Gel is a Oral Gel in the Human Otc Drug category. It is labeled and distributed by Sangleaf Pharm., Co Ltd. The primary component is Hydrogen Peroxide.

• Product ID: 70810-001_680f8bfa-22a1-4650-bbd7-6bbde08388d6
• NDC: 70810-001
• Product Type: Human Otc Drug
• Proprietary Name: Pro Brighten Tooth whitening Gel
• Generic Name: Hydrogen Peroxide
• Dosage Form: Gel
• Route of Administration: ORAL
• Marketing Start Date: 2016-07-06
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part356
• Labeler Name: Sangleaf Pharm., Co Ltd
• Substance Name: HYDROGEN PEROXIDE
• Active Ingredient Strength: 3 g/100g
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 70810-001-02

1 TUBE in 1 CARTON (70810-001-02) > 100 g in 1 TUBE (70810-001-01)

• Marketing Start Date: 2016-07-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70810-001-01 [70810000101]

Pro Brighten Tooth whitening Gel GEL

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-07-06

NDC 70810-001-02 [70810000102]

Pro Brighten Tooth whitening Gel GEL

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-07-06
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
HYDROGEN PEROXIDE	3 g/100g

OpenFDA Data

• SPL SET ID: 5b0c140c-33bf-48b4-9f1e-10fa674c1ee6
• Manufacturer:
  • Sangleaf Pharm., Co Ltd
• UNII:
  • BBX060AN9V

NDC Crossover Matching brand name "Pro Brighten Tooth whitening Gel" or generic name "Hydrogen Peroxide"

NDC	Brand Name	Generic Name
70810-001	Pro Brighten Tooth whitening Gel	Pro Brighten Tooth whitening Gel
0924-0171	First Aid Only Hydrogen Peroxide	Hydrogen Peroxide
0363-0267	Hydrogen Peroxide	Hydrogen Peroxide
0363-0268	Hydrogen Peroxide	Hydrogen Peroxide
0363-0871	Hydrogen Peroxide	HYDROGEN PEROXIDE
0404-0001	Hydrogen Peroxide	Hydrogen Peroxide
0869-0871	Hydrogen Peroxide	HYDROGEN PEROXIDE
10202-001	Hydrogen Peroxide	Hydrogen Peroxide
0924-0932	Hydrogen Peroxide Antiseptic	Hydrogen Peroxide
10031-008	MedPak Peroxide Oral Rinse	HYDROGEN PEROXIDE
0126-0083	Peroxyl Mouth Sore Mild Mint	Hydrogen Peroxide
0363-0085	Sore Mouth Cleanser	Hydrogen Peroxide
0869-0462	Sore Mouth Cleanser	Hydrogen Peroxide