NDC 59448-800 Wellstar Amenity

Benzalkonium Chloride And Sodium Monofluorophosphate Kit - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
59448-800
Proprietary Name:
Wellstar Amenity
Non-Proprietary Name: [1]
Benzalkonium Chloride And Sodium Monofluorophosphate
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Asp Global, Llc
Labeler Code:
59448
FDA Application Number: [6]
part333E
Marketing Category: [8]
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date: [9]
10-01-2021
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
YELLOW (C48330)
BLUE (C48333)
Flavor(s):
MINT (C73404)

Product Packages

NDC Code 59448-800-00

Package Description: 20 BAG in 1 BOX / 1 KIT in 1 BAG * 59 mL in 1 TUBE * 65 mL in 1 BOTTLE, PLASTIC * 4.25 g in 1 TUBE * 59 mL in 1 TUBE * 14 g in 1 BOTTLE, WITH APPLICATOR * 59 mL in 1 TUBE * 10 g in 1 TUBE (42555-060-45) * 53 mL in 1 BOTTLE, PLASTIC (59448-008-01)

Product Details

What is NDC 59448-800?

The NDC code 59448-800 is assigned by the FDA to the product Wellstar Amenity which is a human over the counter drug product labeled by Asp Global, Llc. The generic name of Wellstar Amenity is benzalkonium chloride and sodium monofluorophosphate. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 59448-800-00 20 bag in 1 box / 1 kit in 1 bag * 59 ml in 1 tube * 65 ml in 1 bottle, plastic * 4.25 g in 1 tube * 59 ml in 1 tube * 14 g in 1 bottle, with applicator * 59 ml in 1 tube * 10 g in 1 tube (42555-060-45) * 53 ml in 1 bottle, plastic (59448-008-01). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Wellstar Amenity?

Not recommended for infants.Wet hands thoroughly with product and allow to dry without wiping.Children under 6 years of age should be supervised when using this product. adults and children 2 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physicianchildren 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)children under 2 yearsask a dentist or physician

Which are Wellstar Amenity UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Wellstar Amenity Inactive Ingredients UNII Codes?

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. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Wellstar Amenity?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.0076 MG/MG Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste

* Please review the disclaimer below.

Product Footnotes

[1] 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.

[3] 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.

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

[6] 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.

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] 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.

[12] 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".