NDC 41190-104 Anticavity Fluoride Rinse

Sodium Fluoride

NDC Product Code 41190-104

NDC CODE: 41190-104

Proprietary Name: Anticavity Fluoride Rinse What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Sodium Fluoride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics


NDC Code Structure

  • 41190 - Wakefern Food Corp

NDC 41190-104-44

Package Description: 532 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Anticavity Fluoride Rinse with NDC 41190-104 is a a human over the counter drug product labeled by Wakefern Food Corp. The generic name of Anticavity Fluoride Rinse is sodium fluoride. The product's dosage form is rinse and is administered via oral form.

Labeler Name: Wakefern Food Corp

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 Fluoride Rinse 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.

  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)
  • SORBITOL (UNII: 506T60A25R)
  • WATER (UNII: 059QF0KO0R)

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: Wakefern Food Corp
Labeler Code: 41190
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: 10-19-2007 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".

* Please review the disclaimer below.

Anticavity Fluoride Rinse Product Label Images

Anticavity Fluoride Rinse 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 Ingredient

Sodium fluoride 0.05% (0.02% w/v fluoride ion)


Anticavity rinse


Aids in the prevention of dental cavities



Keep Out Of Reach Of Children.

If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.


• adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste • remove cap• pour 10 milliliters (10 mL mark on inside of cap); do not fill above the 10 mL mark• vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out• do not swallow the rinse• do not eat or drink for 30  minutes after rinsing• instruct children under 12 years of age in good rinsing habits (to minimize swallowing)• supervise children as necessary until capable of using without supervision   • children under 6 years of age: consult a dentist or doctor

Inactive Ingredients

Benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

Other Information

• store at room temperature


SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION"The ADA Council on Scientific Affairs' Acceptance of ShopRite Anticavity Fluoride Rinse is based on the finding that the product is effective in helping to prevent and reduce tooth decay, when used as directed."*This product is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Fluoride RinseWe welcome your questions and comments.Call: 1-800-ShopRiteE-mail: www.shoprite.comWrite: Wakefern Food Corp.600 York St.Elizabeth, NJ 07027Please provide product UPC and codes stamped on productDISTRIBUTED BYWAKEFERN FOOD CORPORATION,5000 RIVERSIDE DRIVEKEASBEY,NJ 08832

* Please review the disclaimer below.