NDC 0363-0171 Anticavity

Sodium Fluoride

NDC Product Code 0363-0171

NDC 0363-0171-86

Package Description: 1000 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Anticavity with NDC 0363-0171 is a a human over the counter drug product labeled by Walgreens. The generic name of Anticavity is sodium fluoride. The product's dosage form is rinse and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 313029.

Dosage Form: Rinse - A liquid used to cleanse by flushing.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Anticavity Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • POLOXAMER 407 (UNII: TUF2IVW3M2)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • PHOSPHORIC ACID (UNII: E4GA8884NN)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Walgreens
Labeler Code: 0363
FDA Application Number: part355 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 08-11-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Anticavity Product Label Images

Anticavity Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

Anticavity rinse

Use

Aids in the prevention of dental cavities

Warning

For this product

Keep Out Of Reach Of Children

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Directions

  • Adults and children 6 years of age and older: use twice daily after brushing your teeth with a toothpastevigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out.do not swallow the rinsedo not eat or drink for 30 minutes after rinsinginstruct children under 12 years of age in good rinsing habits ( to minimize swallowing)supervise children as necessary until capable of using without supervisionchildren under 6 years of age: consult a dentist or doctor

Other Information

  • Store at room temperature cold weather may temporarily cloud this product

Inactive Ingredients

Water, sorbitol, propylene glycol, flavor, sodium lauryl sulfate, poloxamer 407, sodium benzoate, phosphoric acid, sodium saccharin, disodium phosphate, sucralose, red 40, blue 1

Disclaimer

This product is not manufactured or distributed by Johnson & Johnson Consumer Inc. owner of the registered trademark ListerineSEALED WITH PRINTD NECKBND FOR YOUR PROTCTION

Adverse Reactions Section

DISTRIBUTED BY: WALGREEN CO.200 WILMOT RD., DEERFIELD, IL 60015100% SATISFACTION GUARANTEEDwalgreens.com 2020 Walgreen C.MADE IN U.S.A AND FOREIGN COMPONENTS

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