NDC 69491-060

Colgate

Sodium Fluoride

Colgate is a Dental Paste in the Human Otc Drug category. It is labeled and distributed by Buzz Export Services Pty., Ltd.. The primary component is Sodium Fluoride.

• Product ID: 69491-060_57536559-4aee-43ec-a36a-9787a2ce3c7e
• NDC: 69491-060
• Product Type: Human Otc Drug
• Proprietary Name: Colgate
• Generic Name: Sodium Fluoride
• Dosage Form: Paste
• Route of Administration: DENTAL
• Marketing Start Date: 2014-12-03
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part355
• Labeler Name: Buzz Export Services Pty., Ltd.
• Substance Name: SODIUM FLUORIDE
• Active Ingredient Strength: 2 mg/g
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 69491-060-45

1 TUBE in 1 BAG (69491-060-45) > 5 g in 1 TUBE

• Marketing Start Date: 2014-12-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69491-060-45 [69491006045]

Colgate PASTE

• Marketing Category: OTC monograph final
• Application Number: part355
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2014-12-03
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-03-04

NDC 69491-060-94 [69491006094]

Colgate PASTE

• Marketing Category: OTC monograph final
• Application Number: part355
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2014-12-03
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-03-04

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM FLUORIDE	1.5 mg/g

OpenFDA Data

• SPL SET ID: f84217da-dc78-4181-9fcc-6b11e92276ff
• Manufacturer:
  • Buzz Export Services Pty., Ltd.
• UNII:
  • 8ZYQ1474W7
• RxNorm Concept Unique ID - RxCUI:
  • 545626

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

NDC	Brand Name	Generic Name
0126-0021	Colgate	SODIUM FLUORIDE
69491-060	Colgate	Colgate
0135-0234	AQUAFRESH	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