NDC 36800-481

Topco Associates LLC Maximum Strength

Fluoride

Topco Associates LLC Maximum Strength is a Dental Paste, Dentifrice in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Sodium Fluoride; Potassium Nitrate.

• Product ID: 36800-481_8878c78d-128e-429b-868d-4364f9fcb364
• NDC: 36800-481
• Product Type: Human Otc Drug
• Proprietary Name: Topco Associates LLC Maximum Strength
• Generic Name: Fluoride
• Dosage Form: Paste, Dentifrice
• Route of Administration: DENTAL
• Marketing Start Date: 2011-01-20
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part356
• Labeler Name: Topco Associates LLC
• Substance Name: SODIUM FLUORIDE; POTASSIUM NITRATE
• Active Ingredient Strength: 0 g/100g; g/100g
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 36800-481-49

1 TUBE in 1 CARTON (36800-481-49) > 113 g in 1 TUBE (36800-481-42)

• Marketing Start Date: 2012-11-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 36800-481-42 [36800048142]

Topco Associates LLC Maximum Strength PASTE, DENTIFRICE

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2011-01-20

NDC 36800-481-49 [36800048149]

Topco Associates LLC Maximum Strength PASTE, DENTIFRICE

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-11-15

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM FLUORIDE	.24 g/100g

OpenFDA Data

• SPL SET ID: ac398ff0-0010-4e13-8b89-dc986fd7f974
• Manufacturer:
  • Topco Associates LLC
• UNII:
  • RU45X2JN0Z
  • 8ZYQ1474W7
• RxNorm Concept Unique ID - RxCUI:
  • 1038929

NDC Crossover Matching brand name "Topco Associates LLC Maximum Strength" 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