NDC 0126-0021

Colgate Dry Mouth Relief

Sodium Fluoride

Colgate Dry Mouth Relief is a Dental Rinse in the Human Otc Drug category. It is labeled and distributed by Colgate Oral Pharmaceuticals, Inc.. The primary component is Sodium Fluoride.

• Product ID: 0126-0021_48d783af-cd13-454c-b061-ea713b967024
• NDC: 0126-0021
• Product Type: Human Otc Drug
• Proprietary Name: Colgate Dry Mouth Relief
• Generic Name: Sodium Fluoride
• Dosage Form: Rinse
• Route of Administration: DENTAL
• Marketing Start Date: 2011-01-14
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part355
• Labeler Name: Colgate Oral Pharmaceuticals, Inc.
• Substance Name: SODIUM FLUORIDE
• Active Ingredient Strength: 2 mg/10mL
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 0126-0021-03

59 mL in 1 BOTTLE (0126-0021-03)

• Marketing Start Date: 2011-01-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0126-0021-03 [00126002103]

Colgate Dry Mouth Relief RINSE

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part355
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2011-01-14
• Marketing End Date: 2019-06-30

NDC 0126-0021-16 [00126002116]

Colgate Dry Mouth Relief RINSE

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part355
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2011-01-14
• Marketing End Date: 2019-06-30

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM FLUORIDE	2.1 mg/10mL

OpenFDA Data

• SPL SET ID: 5bd056bf-b43b-4b7a-8f11-5efe8bd81136
• Manufacturer:
  • Colgate Oral Pharmaceuticals, Inc.
• UNII:
  • 8ZYQ1474W7
• RxNorm Concept Unique ID - RxCUI:
  • 1117122
  • 1100563

NDC Crossover Matching brand name "Colgate Dry Mouth Relief" 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