Toothy Oral Solution
NDC 54465-001

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 54465-001?
  5. Toothy Oral Solution Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Toothy Oral Solution is a UNAPPROVED DRUG OTHER-approved product labeled by Shenzhen Roselle Bio-technology Holding Co.,ltd.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a product. This product entry covers the primary NDC 54465-001 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
54465-001
Proprietary Name:
Toothy Oral Solution
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Shenzhen Roselle Bio-technology Holding Co.,ltd.
Labeler Code:
54465
Product Label ID:
a35029bf-b6cb-c5ef-e053-2a95a90ab729
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.

Marketing Timeline

Start Marketing Date: [9]
04-15-2020
Listing Expiration Date: [11]
12-31-2021
Exclude Flag: [12]
I

Product Characteristics

Flavor(s):

Code Structure Chart

Product Details

What is NDC 54465-001?

The NDC code 54465-001 is assigned by the FDA to the product Toothy Oral Solution. This pharmaceutical product is labeled by Shenzhen Roselle Bio-technology Holding Co.,ltd. and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 54465-001-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

For external use only. Open the dust cover, tilt your head slightly backwards, rotate the nozzle to the front of the mouth,tap the manual pump, and spray the antibacterial solution into mouth. The recommended dosage is 4 sprays per use (3-4 times per day), however this product can be used more times per day depending on specific situations. Clean the nozzle and put the dust cover back on after each use.

Which are the associated UNII Codes?

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

  • SOPHORA FLAVESCENS WHOLE (UNII: X8KX602M5L)
  • SOPHORA FLAVESCENS WHOLE (UNII: X8KX602M5L) (Active Moiety)
  • HOUTTUYNIA CORDATA WHOLE (UNII: O3E12ZLW5T)
  • HOUTTUYNIA CORDATA WHOLE (UNII: O3E12ZLW5T) (Active Moiety)

Which are the Inactive Ingredients associated 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:

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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".