NDC 59883-004

Fluoridex

Stannous Fluoride Rinse

Fluoridex is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Den-mat Holdings, Llc. The primary component is Stannous Fluoride.

• Product ID: 59883-004_75c4bbf8-c52d-243b-e053-2a91aa0a45fe
• NDC: 59883-004
• Product Type: Human Otc Drug
• Proprietary Name: Fluoridex
• Generic Name: Stannous Fluoride Rinse
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2016-01-11
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part355
• Labeler Name: DEN-MAT HOLDINGS, LLC
• Substance Name: STANNOUS FLUORIDE
• Active Ingredient Strength: 2 mg/g
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 59883-004-01

1 BOTTLE, PLASTIC in 1 BOX (59883-004-01) > 310 g in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2016-01-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59883-004-01 [59883000401]

Fluoridex LIQUID

• Marketing Category: OTC monograph final
• Application Number: part355
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-01-11

Drug Details

Active Ingredients

Ingredient	Strength
STANNOUS FLUORIDE	1.53 mg/g

OpenFDA Data

• SPL SET ID: 5e81f073-c0ca-aa38-e053-2a91aa0ab37b
• Manufacturer:
  • DEN-MAT HOLDINGS, LLC
• UNII:
  • 3FTR44B32Q

NDC Crossover Matching brand name "Fluoridex" or generic name "Stannous Fluoride Rinse"

NDC	Brand Name	Generic Name
59883-004	Fluoridex	Stannous Fluoride Rinse
59883-015	FLUORIDEX	Sodium Fluoride
59883-016	FLUORIDEX	Sodium Fluoride
59883-020	FLUORIDEX	Sodium Fluoride
59883-030	FLUORIDEX	Sodium Fluoride
59883-031	FLUORIDEX	Sodium Fluoride