NDC 73333-125

Smile Direct Club

Sodium Fluoride Toothpaste

Smile Direct Club is a Oral Paste, Dentifrice in the Human Otc Drug category. It is labeled and distributed by Nutrix, Llc. The primary component is Sodium Fluoride.

• Product ID: 73333-125_936893e2-518f-5139-e053-2a95a90a076c
• NDC: 73333-125
• Product Type: Human Otc Drug
• Proprietary Name: Smile Direct Club
• Generic Name: Sodium Fluoride Toothpaste
• Dosage Form: Paste, Dentifrice
• Route of Administration: ORAL
• Marketing Start Date: 2019-09-25
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part355
• Labeler Name: Nutrix, LLC
• Substance Name: SODIUM FLUORIDE
• Active Ingredient Strength: 2 mg/g
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 73333-125-02

1 TUBE in 1 CARTON (73333-125-02) > 125 g in 1 TUBE

• Marketing Start Date: 2019-09-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 73333-125-01 [73333012501]

Smile Direct Club PASTE, DENTIFRICE

• Marketing Category: OTC monograph final
• Application Number: part355
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-09-25

NDC 73333-125-02 [73333012502]

Smile Direct Club PASTE, DENTIFRICE

• Marketing Category: OTC monograph final
• Application Number: part355
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-09-25

NDC 73333-125-03 [73333012503]

Smile Direct Club PASTE, DENTIFRICE

• Marketing Category: OTC monograph final
• Application Number: part355
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-09-25

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM FLUORIDE	2.4 mg/g

NDC Crossover Matching brand name "Smile Direct Club" or generic name "Sodium Fluoride Toothpaste"

NDC	Brand Name	Generic Name
73333-125	Smile Direct Club	Sodium Fluoride Toothpaste
73333-126	Smile Direct Club	Sensitivity Toothpaste
81301-0513	DOWN Toothpaste,Gingersnap	Sodium Fluoride Toothpaste
70926-100	Linhart	Sodium Fluoride Toothpaste
73333-096	LINHART	Sodium Fluoride Toothpaste
81301-0512	UP Toothpaste,Lemon Citron	Sodium Fluoride Toothpaste