NDC 0126-0016

PreviDent 5000 Dry Mouth

Sodium Fluoride

PreviDent 5000 Dry Mouth is a Dental Gel, Dentifrice in the Human Prescription Drug category. It is labeled and distributed by Colgate Oral Pharmaceuticals Inc.. The primary component is Sodium Fluoride.

• Product ID: 0126-0016_50488c66-4136-4137-842c-444cb65535ae
• NDC: 0126-0016
• Product Type: Human Prescription Drug
• Proprietary Name: PreviDent 5000 Dry Mouth
• Generic Name: Sodium Fluoride
• Dosage Form: Gel, Dentifrice
• Route of Administration: DENTAL
• Marketing Start Date: 2009-07-06
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Colgate Oral Pharmaceuticals Inc.
• Substance Name: SODIUM FLUORIDE
• Active Ingredient Strength: 6 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0126-0016-61

100 mL in 1 BOTTLE (0126-0016-61)

• Marketing Start Date: 2009-07-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0126-0016-61 [00126001661]

PreviDent 5000 Dry Mouth GEL, DENTIFRICE

• Marketing Category: UNAPPROVED DRUG OTHER
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2009-07-06

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM FLUORIDE	6.1 mg/mL

OpenFDA Data

• SPL SET ID: d93ee76f-454b-40bf-9357-39a2ae3b6ccb
• Manufacturer:
  • Colgate Oral Pharmaceuticals Inc.
• UNII:
  • 8ZYQ1474W7
• UPC Code:
  • 0301260016610

NDC Crossover Matching brand name "PreviDent 5000 Dry Mouth" or generic name "Sodium Fluoride"

NDC	Brand Name	Generic Name
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