NDC 55882-6118 Hello Unicorn Splash Anticavity Fluoride Rinse

Sodium Fluoride

NDC Product Code 55882-6118

NDC CODE: 55882-6118

Proprietary Name: Hello Unicorn Splash 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

Flavor(s):
BUBBLE GUM (C73368)

NDC Code Structure

  • 55882 - Hello Products Llc

NDC 55882-6118-1

Package Description: 473 mL in 1 BOTTLE

NDC Product Information

Hello Unicorn Splash Anticavity Fluoride Rinse with NDC 55882-6118 is a a human over the counter drug product labeled by Hello Products Llc. The generic name of Hello Unicorn Splash Anticavity Fluoride Rinse is sodium fluoride. The product's dosage form is mouthwash and is administered via dental form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 240698.

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.

Hello Unicorn Splash 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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • XYLITOL (UNII: VCQ006KQ1E)
  • SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
  • POLOXAMER 407 (UNII: TUF2IVW3M2)
  • POTASSIUM CITRATE (UNII: EE90ONI6FF)
  • PHOSPHORIC ACID (UNII: E4GA8884NN)

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: Hello Products Llc
Labeler Code: 55882
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: 01-03-2022 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.

Hello Unicorn Splash Anticavity Fluoride Rinse Product Label Images

Hello Unicorn Splash 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

Other

Drug Facts

Dist. by Hello Products LLCMontclair, NJ 07042

Active Ingredient

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

Purpose

Anticavity

Use

Aids in the prevention of dental cavities.

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.

Directions

  • Adults and children 6 years of age and older:use once a day after brushing your teeth with a 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

Other Information

  • Store at room temperaturedo not use if printed band around cap is broken or missing

Inactive Ingredients

Purified water, vegetable glycerin, xylitol, sodium phosphate monobasic, flavor, poloxamer 407, potassium citrate, phosphoric acid

Questions?

1-855-444-3556

* Please review the disclaimer below.