NDC 61508-0167

60 Second Gel Orange Cream

Fluoride Gel

60 Second Gel Orange Cream is a Dental Gel, Dentifrice in the Human Otc Drug category. It is labeled and distributed by Germiphene Corporation. The primary component is Sodium Fluoride.

• Product ID: 61508-0167_487f6aa0-be7e-39f8-e054-00144ff88e88
• NDC: 61508-0167
• Product Type: Human Otc Drug
• Proprietary Name: 60 Second Gel Orange Cream
• Generic Name: Fluoride Gel
• Dosage Form: Gel, Dentifrice
• Route of Administration: DENTAL
• Marketing Start Date: 2017-02-24
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Germiphene Corporation
• Substance Name: SODIUM FLUORIDE
• Active Ingredient Strength: 2 g/100g
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 61508-0167-1

450 g in 1 BOTTLE, PLASTIC (61508-0167-1)

• Marketing Start Date: 2017-02-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61508-0167-1 [61508016701]

60 Second Gel Orange Cream GEL, DENTIFRICE

• Marketing Category: unapproved drug other
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-02-24
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM FLUORIDE	1.69 g/100g

OpenFDA Data

• SPL SET ID: 487f6aa0-be7d-39f8-e054-00144ff88e88
• Manufacturer:
  • Germiphene Corporation
• UNII:
  • 8ZYQ1474W7

NDC Crossover Matching brand name "60 Second Gel Orange Cream" or generic name "Fluoride Gel"

NDC	Brand Name	Generic Name
61508-0167	60 Second Gel Orange Cream	Fluoride gel
61508-0163	60 Second Gel Bubblegum	Fluoride gel
61508-0165	60 Second Gel Grape	Fluoride gel
61508-0166	60 Second Gel Mint	Fluoride gel
61508-0169	60 Second Gel Strawberry	Fluoride gel
61508-0176	Gel 7 Neutral Topical Fluoride Gel Mint	Fluoride Gel
61508-0179	Gel 7 Neutral Topical Fluoride Gel Strawberry	Fluoride Gel