NDC 0273-8011

FLUORISHIELD

Sodium Fluoride

FLUORISHIELD is a Dental Gel in the Human Prescription Drug category. It is labeled and distributed by Young Dental Manufacturing I, Llc. The primary component is Sodium Fluoride.

• Product ID: 0273-8011_93cf110a-e80f-47c4-bf14-2d7bc0aa3bad
• NDC: 0273-8011
• Product Type: Human Prescription Drug
• Proprietary Name: FLUORISHIELD
• Generic Name: Sodium Fluoride
• Dosage Form: Gel
• Route of Administration: DENTAL
• Marketing Start Date: 2017-09-21
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Young Dental Manufacturing I, LLC
• Substance Name: SODIUM FLUORIDE
• Active Ingredient Strength: 11 mg/g
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0273-8011-01

114 g in 1 TUBE (0273-8011-01)

• Marketing Start Date: 2017-09-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0273-8011-01 [00273801101]

FLUORISHIELD GEL

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-09-21
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM FLUORIDE	11 mg/g

OpenFDA Data

• SPL SET ID: dbba58a0-ce17-4fc0-ba81-625d78c1a9e6
• Manufacturer:
  • Young Dental Manufacturing I, LLC
• UNII:
  • 8ZYQ1474W7

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

NDC	Brand Name	Generic Name
10733-130	FluoriSHIELD	FluoriSHIELD
0273-8011	FLUORISHIELD	FLUORISHIELD
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