NDC 59883-016

FLUORIDEX

Sodium Fluoride

FLUORIDEX is a Dental Paste, Dentifrice in the Human Prescription Drug category. It is labeled and distributed by Den-mat Holdings, Llc.. The primary component is Sodium Fluoride.

• Product ID: 59883-016_82f8ac58-f95d-255b-e053-2a91aa0aceb7
• NDC: 59883-016
• Product Type: Human Prescription Drug
• Proprietary Name: FLUORIDEX
• Generic Name: Sodium Fluoride
• Dosage Form: Paste, Dentifrice
• Route of Administration: DENTAL
• Marketing Start Date: 2016-12-30
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: DEN-MAT HOLDINGS, LLC.
• Substance Name: SODIUM FLUORIDE
• Active Ingredient Strength: 5 mg/g
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 59883-016-04

1 TUBE in 1 BOX (59883-016-04) > 112 g in 1 TUBE

• Marketing Start Date: 2016-12-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59883-016-04 [59883001604]

FLUORIDEX PASTE, DENTIFRICE

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2016-12-30

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM FLUORIDE	5 mg/g

OpenFDA Data

• SPL SET ID: 5fd60635-4b66-15e3-e053-2991aa0ab23a
• Manufacturer:
  • DEN-MAT HOLDINGS, LLC.
• UNII:
  • 8ZYQ1474W7

NDC Crossover Matching brand name "FLUORIDEX" or generic name "Sodium Fluoride"

NDC	Brand Name	Generic Name
59883-016	FLUORIDEX	FLUORIDEX
59883-031	FLUORIDEX	FLUORIDEX
59883-004	Fluoridex	Fluoridex
59883-020	FLUORIDEX	FLUORIDEX
59883-030	FLUORIDEX	FLUORIDEX
59883-015	FLUORIDEX	FLUORIDEX
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