NDC 0404-3963

Acclean 60 Second Fluoride Treatment

Fluoride

Acclean 60 Second Fluoride Treatment is a Dental Gel in the Human Prescription Drug category. It is labeled and distributed by Henry Schein Inc.. The primary component is Sodium Fluoride.

• Product ID: 0404-3963_7de26fe4-4799-4f11-e053-2991aa0aeb07
• NDC: 0404-3963
• Product Type: Human Prescription Drug
• Proprietary Name: Acclean 60 Second Fluoride Treatment
• Generic Name: Fluoride
• Dosage Form: Gel
• Route of Administration: DENTAL
• Marketing Start Date: 2017-03-03
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Henry Schein Inc.
• Substance Name: SODIUM FLUORIDE
• Active Ingredient Strength: 0 g/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0404-3963-03

12 BOTTLE, PLASTIC in 1 CASE (0404-3963-03) > 480 mL in 1 BOTTLE, PLASTIC (0404-3963-01)

• Marketing Start Date: 2017-03-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0404-3963-01 [00404396301]

Acclean 60 Second Fluoride Treatment GEL

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-03-03

NDC 0404-3963-03 [00404396303]

Acclean 60 Second Fluoride Treatment GEL

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-03-03

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM FLUORIDE	.0272 g/mL

OpenFDA Data

• SPL SET ID: 496786d3-527f-104d-e054-00144ff88e88
• Manufacturer:
  • Henry Schein Inc.
• UNII:
  • 8ZYQ1474W7
• RxNorm Concept Unique ID - RxCUI:
  • 1535362

NDC Crossover Matching brand name "Acclean 60 Second Fluoride Treatment" or generic name "Fluoride"

NDC	Brand Name	Generic Name
0404-3339	Acclean	Fluoride
0404-3963	Acclean	Fluoride
0404-4447	Acclean	Fluoride
0404-4448	Acclean	Fluoride
0404-5676	Acclean	Fluoride
0404-9034	Acclean	Fluoride
0404-9035	Acclean	Fluoride
0404-9405	Acclean	Fluoride
37808-167	HEB	Fluoride
30142-148	Kroger	Fluoride
30142-149	Kroger	Fluoride
30142-621	Kroger Company	Fluoride
36800-185	Live Better	Fluoride
34362-0237	Peppermint Twist	Fluoride
11822-5020	Rite Aid	Fluoride
11822-6020	Rite Aid	Fluoride
34362-0232	The Natural Dentist	Fluoride
34362-0233	The Natural Dentist	Fluoride
34362-0270	The Natural Dentist	Fluoride
36800-186	Top Care	Fluoride
36800-681	Top Care	Fluoride
36800-481	Topco Associates LLC	Fluoride