NDC 52376-045 Sunstar G.u.m Hydral Dry Mouth Relief

Sodium Fluoride

NDC Product Code 52376-045

NDC CODE: 52376-045

Proprietary Name: Sunstar G.u.m Hydral Dry Mouth Relief 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to prevent cavities. It makes teeth stronger and more resistant to decay caused by acid and bacteria. Talk to your dentist or doctor about the benefits and risks of this product. This medication is not recommended for use in infants less than 6 months of age. This medication is not recommended for use in areas where the fluoride content in the water supply is greater than 0.6 parts per million. See Notes section for more information.

NDC Code Structure

  • 52376 - Sunstar Americas, Inc.
    • 52376-045 - Sunstar G.u.m Hydral Dry Mouth Relief

NDC 52376-045-11

Package Description: 1 TUBE in 1 CARTON > 119 g in 1 TUBE

NDC Product Information

Sunstar G.u.m Hydral Dry Mouth Relief with NDC 52376-045 is a a human over the counter drug product labeled by Sunstar Americas, Inc.. The generic name of Sunstar G.u.m Hydral Dry Mouth Relief is sodium fluoride. The product's dosage form is paste, dentifrice and is administered via dental form.

Labeler Name: Sunstar Americas, Inc.

Dosage Form: Paste, Dentifrice - A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.

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.

Sunstar G.u.m Hydral Dry Mouth Relief 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 .24 g/100g

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.

  • SORBITOL (UNII: 506T60A25R)
  • WATER (UNII: 059QF0KO0R)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • ISOMALT (UNII: S870P55O2W)
  • LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • XYLITOL (UNII: VCQ006KQ1E)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • GINGER (UNII: C5529G5JPQ)

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.
  • 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: Sunstar Americas, Inc.
Labeler Code: 52376
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: 11-19-2019 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.

Sunstar G.u.m Hydral Dry Mouth Relief Product Label Images

Sunstar G.u.m Hydral Dry Mouth Relief 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 0.24% w/w

Purpose

Anticavity

Uses

Aids in the prevention of dental cavities

Otc - Keep Out Of Reach Of Children

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control center right away

Directions

Adults and children 2 years & older; brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctorInstruct children under 6 years of age in good brushing and rinsing habits, to minimize swallowingSupervise children as necessary until capable of using without supervisionChildren under 2 years of age - consult a dentist or doctor

Inactive Ingredients:

Sorbitol, purified water, hydrated silica, isomalt, lauryl glucoside, cocamidopropyl betaine, PEG-8, xanthan gum, xylitol, panthenol, flavor, sodium benzoate, sucralose, tocopheryl acetate, aloe barbadenisis leaf juice powder, cetylpyridinium chloride, bisabolol, FD&C blue #1, zingiber officinale (ginger) root extract.

Questions:

1-888-777-3101

* Please review the disclaimer below.