NDC 0404-8016

Acclean

Sodium Flouride

Acclean is a Oral Gel, Dentifrice in the Human Prescription Drug category. It is labeled and distributed by Henry Schein Inc.. The primary component is Sodium Fluoride.

• Product ID: 0404-8016_4b579b08-3519-42f2-92fc-110fda9ff281
• NDC: 0404-8016
• Product Type: Human Prescription Drug
• Proprietary Name: Acclean
• Generic Name: Sodium Flouride
• Dosage Form: Gel, Dentifrice
• Route of Administration: ORAL
• Marketing Start Date: 1997-01-01
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Henry Schein Inc.
• Substance Name: SODIUM FLUORIDE
• Active Ingredient Strength: 5 mg/g
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 0404-8016-02

56 g in 1 TUBE (0404-8016-02)

• Marketing Start Date: 1997-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0404-8016-02 [00404801602]

Acclean GEL, DENTIFRICE

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1997-01-01
• Inactivation Date: 2019-11-27

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM FLUORIDE	5 mg/g

OpenFDA Data

• SPL SET ID: fd7602a5-8cd9-447e-92f0-e399276f4dd4
• Manufacturer:
  • Henry Schein Inc.
• UNII:
  • 8ZYQ1474W7
• RxNorm Concept Unique ID - RxCUI:
  • 392038

NDC Crossover Matching brand name "Acclean" or generic name "Sodium Flouride"

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
0404-8016	Acclean	Sodium Flouride
0404-9034	Acclean	Fluoride
0404-9035	Acclean	Fluoride
0404-9405	Acclean	Fluoride
0404-0118	Acclean plus	Sodium Flouride
0404-6918	Acclean Plus	Sodium Flouride
0404-6919	Acclean Plus	Sodium Flouride
80058-002	arpha Stain Clear	Sodium Flouride
76670-0002	Cool Sense Care Plus Mouthwash	Sodium Flouride
76670-0003	Doctrust K	Sodium Flouride
81840-3333	Hoo gargle (apple spearmint flavor)	Sodium Flouride
81840-0004	Hoo gargle (apple spearmint flavoring)	Sodium Flouride
81840-0002	Hoo gargle (Jasmine Flavor)(Mouthwash)	Sodium Flouride
81840-1111	Hoo gargle (Jasmine Flavor)(Mouthwash)	Sodium Flouride
81840-0001	Hoo gargle (Mouthwash)	Sodium Flouride
81840-0003	Hoo gargle (Rooibos Tea Flavor)(Mouthwash)	Sodium Flouride
81840-2222	Hoo gargle (Rooibos Tea Flavor)(Mouthwash)	Sodium Flouride
29494-1104	VividSensiGuard	Sodium Flouride