NDC 55319-233 Family Wellness Anticavity Fresh Mint

Sodium Fluoride

NDC Product Code 55319-233

NDC Code: 55319-233

Proprietary Name: Family Wellness Anticavity Fresh Mint 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.

NDC Code Structure

  • 55319 - Family Dollar Services Inc.
    • 55319-233 - Family Wellness

NDC 55319-233-86

Package Description: 1000 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Family Wellness Anticavity Fresh Mint with NDC 55319-233 is a a human over the counter drug product labeled by Family Dollar Services Inc.. The generic name of Family Wellness Anticavity Fresh Mint is sodium fluoride. The product's dosage form is mouthwash and is administered via dental form.

Labeler Name: Family Dollar Services Inc.

Dosage Form: Mouthwash - An aqueous solution which is most often used for its deodorant, refreshing, or antiseptic effect.

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.

Family Wellness Anticavity Fresh Mint 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.

  • SODIUM FLUORIDE .02 g/100mL

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)
  • PHOSPHORIC ACID (UNII: E4GA8884NN)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • POLOXAMER 407 (UNII: TUF2IVW3M2)
  • SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)
  • FOOD YELLOW 3 FREE ACID (UNII: G2B7JWK1GG)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • SACCHARIN (UNII: FST467XS7D)
  • 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.

  • Dental - Administration to a tooth or teeth.

Product Labeler Information

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

Labeler Name: Family Dollar Services Inc.
Labeler Code: 55319
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: 06-20-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Family Wellness Anticavity Fresh Mint Product Label Images

Family Wellness Anticavity Fresh Mint 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

Other

Drug Facts

DISTRIBUTED BY: Midwood Brands, LLC
500 Volvo Parkway, Chesapeake, VA 23320Made in Canada* This product is not manufactured or distributed by Johnson & Johnson, distributor of Listerine®.

Otc - Active Ingredient

Active ingredient
Sodium fluoride 0.0221%

Otc - Purpose

PurposeAnticavity

Indications & Usage

Useaids in the prevention of dental cavities

Warnings

Warnings

Otc - Keep Out Of Reach Of Children

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.

Dosage & Administration

  • Directionsadults and children 12 years of age and older: use twice daily after brushing your teeth with toothpaste; vigorously swish 10 mL (2 teaspoonfuls) between teeth for 1 minute then spit out; do not swallowchildren under 12 years of age: consult a dentist or doctor

Storage And Handling

Other information cold weather may cloud this product. Its antiseptic properties are not affected
. Store at room temperature (59° - 77°F)

Inactive Ingredient

Inactive ingredients water, sorbitol, alcohol 21.6%, flavors, poloxamer 407, sodium lauryl sulfate, phosphoric acid, sucralose and/or sodium saccharin, dibasic sodium phosphate, D&C red no. 33, FD&C blue no. 1, FD&C yellow no. 6.

* Please review the disclaimer below.

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