NDC 42361-081 Blingday Bubble Candy Solid Mouthwash

Sodium Fluoride

NDC Product Code 42361-081

NDC 42361-081-01

Package Description: 16 DOSE PACK in 1 CASE > 850 mg in 1 DOSE PACK

NDC Product Information

Blingday Bubble Candy Solid Mouthwash with NDC 42361-081 is a a human over the counter drug product labeled by Dong Sung Bio Pharm. Co., Ltd.. The generic name of Blingday Bubble Candy Solid Mouthwash is sodium fluoride. The product's dosage form is pellet and is administered via oral form.

Labeler Name: Dong Sung Bio Pharm. Co., Ltd.

Dosage Form: Pellet - A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding.

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.

Blingday Bubble Candy Solid Mouthwash 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 .00066 mg/1.1mg

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)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • XYLITOL (UNII: VCQ006KQ1E)
  • PEPPERMINT (UNII: V95R5KMY2B)
  • MENTHOL (UNII: L7T10EIP3A)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • ERYTHRITOL (UNII: RA96B954X6)
  • ACESULFAME (UNII: MA3UYZ6K1H)

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: Dong Sung Bio Pharm. Co., Ltd.
Labeler Code: 42361
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: 09-09-2019 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.

Blingday Bubble Candy Solid Mouthwash Product Label Images

Blingday Bubble Candy Solid Mouthwash 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

Drug Facts

Sodium Fluoride 0.13% (0.06% w/w fluoride ion)

Anticavity

Uses

Aids in the prevention of dental cavities. Helps to refresh your breath.

Warnings

Stop use and ask a dentist if oral irritation or tooth sensitivity occurs.

Keep this out of reach of children under 6 years of age. 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: Place 1 tablet into the mouth and start chewing. Swish the bubbles between your teeth for 30 seconds to 1 minute and then spit out. Rinse out the residue with water. Recommended daily usage: 1 tablet per each use, 2 to 5 uses per day. Children under 6 years of age: consult a dentist or doctor before use.

Inactive Ingredients

Sorbitol, Sodium Bicarbonate, Microcrystalline Cellulose, Lactose, Anhydrous Citric Acid, Xylitol, Sodium Lauryl Sulfate, Peppermint, Magnesium Stearate, L-Menthol, Erythritol, Sucralose, Acesulfame Potassium, Sodium Chloride

Other Information

This product is not intended to replace brushing or flossing. Store in a cool, dry place.

Otc - Questions

Call (562) 802-0131 / www.dseshopusa.com

* Please review the disclaimer below.