NDC 55319-234 Family Wellness Total Health

Cetylpyridinium Chloride

NDC Product Code 55319-234

NDC Code: 55319-234

Proprietary Name: Family Wellness Total Health 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: Cetylpyridinium Chloride 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.
    • 55319-234 - Family Wellness

NDC 55319-234-86

Package Description: 1000 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Family Wellness Total Health with NDC 55319-234 is a a human over the counter drug product labeled by Family Dollar Services Inc.. The generic name of Family Wellness Total Health is cetylpyridinium chloride. The product's dosage form is rinse and is administered via oral form.

Labeler Name: Family Dollar Services Inc.

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.

Family Wellness Total Health 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.

  • CETYLPYRIDINIUM CHLORIDE .07 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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • POLOXAMER 407 (UNII: TUF2IVW3M2)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • SACCHARIN (UNII: FST467XS7D)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • 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: Family Dollar Services Inc.
Labeler Code: 55319
FDA Application Number: part356 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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 Total Health Product Label Images

Family Wellness Total Health 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 23320
Made in Canada* This product is not manufactured or distributed by Proctor and Gamble, distributor of Crest®.

Otc - Active Ingredient

Active ingredients
Cetylpyridinium chloride 0.07%

Otc - Purpose

PurposeAntigingivitis, Antiplaque

Indications & Usage

Usehelps control plaque that leads to gingivitis

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 6 years of age and older: use twice a day after brushing your teeth with toothpastevigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit outdo 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

Inactive Ingredient

Inactive ingredients water, glycerin, flavor, poloxamer 407, sodium saccharin and/or sucralose, citric acid, blue 1.

* Please review the disclaimer below.

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