NDC 47649-1102

Dr.Whitiss 15%

Carbamide Peroxide, Sodium Fluoride

Dr.Whitiss 15% is a Dental Gel, Dentifrice in the Human Otc Drug category. It is labeled and distributed by Nibec Co., Ltd.. The primary component is Carbamide Peroxide; Sodium Fluoride.

• Product ID: 47649-1102_9968aa66-9eed-1b39-e053-2995a90a1ecc
• NDC: 47649-1102
• Product Type: Human Otc Drug
• Proprietary Name: Dr.Whitiss 15%
• Generic Name: Carbamide Peroxide, Sodium Fluoride
• Dosage Form: Gel, Dentifrice
• Route of Administration: DENTAL
• Marketing Start Date: 2015-06-07
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part356
• Labeler Name: NIBEC Co., Ltd.
• Substance Name: CARBAMIDE PEROXIDE; SODIUM FLUORIDE
• Active Ingredient Strength: 150 mg/g; mg/g
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 47649-1102-2

4 SYRINGE in 1 PACKAGE (47649-1102-2) > 1 g in 1 SYRINGE (47649-1102-1)

• Marketing Start Date: 2015-06-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 47649-1102-2 [47649110202]

Dr.Whitiss 15% GEL, DENTIFRICE

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2015-06-07

NDC 47649-1102-1 [47649110201]

Dr.Whitiss 15% GEL, DENTIFRICE

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2015-06-07

Drug Details

Active Ingredients

Ingredient	Strength
CARBAMIDE PEROXIDE	150 mg/g

NDC Crossover Matching brand name "Dr.Whitiss 15%" or generic name "Carbamide Peroxide, Sodium Fluoride"

NDC	Brand Name	Generic Name
47649-1101	Dr.Whitiss 15%	CARBAMIDE PEROXIDE
47649-1102	Dr.Whitiss 15%	CARBAMIDE PEROXIDE, SODIUM FLUORIDE