NDC 48878-4061

OMNI

Stannous Fluoride

OMNI is a Oral Gel in the Human Otc Drug category. It is labeled and distributed by 3m Espe Dental Products. The primary component is Stannous Fluoride.

• Product ID: 48878-4061_1d0aaf79-b839-4514-bca9-401af9b10869
• NDC: 48878-4061
• Product Type: Human Otc Drug
• Proprietary Name: OMNI
• Generic Name: Stannous Fluoride
• Dosage Form: Gel
• Route of Administration: ORAL
• Marketing Start Date: 1998-02-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part355
• Labeler Name: 3M ESPE Dental Products
• Substance Name: STANNOUS FLUORIDE
• Active Ingredient Strength: 1 mg/g
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 48878-4061-3

1 TUBE in 1 BOX (48878-4061-3) > 121.9 g in 1 TUBE

• Marketing Start Date: 1998-02-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 48878-4061-3 [48878406103]

OMNI GEL

• Marketing Category: OTC monograph final
• Application Number: part355
• Product Type: HUMAN OTC DRUG
• Billing Unit: GM
• Marketing Start Date: 1998-02-01

Drug Details

Active Ingredients

Ingredient	Strength
STANNOUS FLUORIDE	.969 mg/g

OpenFDA Data

• SPL SET ID: 0c2a81b1-65b5-432b-8e66-30432a245aba
• Manufacturer:
  • 3M ESPE Dental Products
• UNII:
  • 3FTR44B32Q

NDC Crossover Matching brand name "OMNI" or generic name "Stannous Fluoride"

NDC	Brand Name	Generic Name
48878-4061	OMNI	OMNI
0126-0165	Gel-Kam Fruit and Berry	Stannous Fluoride
0126-0192	Gel-Kam Mint	Stannous Fluoride
0135-0598	parodontax	stannous fluoride
0135-0599	parodontax	stannous fluoride
0135-0601	parodontax	stannous fluoride
0135-0547	SENSODYNE	stannous fluoride
0135-0548	SENSODYNE	stannous fluoride
0135-0575	SENSODYNE	stannous fluoride
0135-0621	SENSODYNE	stannous fluoride
0135-0622	SENSODYNE	stannous fluoride
0135-0572	Sensodyne Complete Protection	stannous fluoride
0135-0573	Sensodyne Complete Protection	stannous fluoride