NDC 55346-0943 Alpha-pro
Sodium Fluoride And Hydrofluoric Acid Gel Dental - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 55346 - Dental Technologies, Inc.
- 55346-0943 - Alpha-pro
Product Characteristics
Product Packages
NDC Code 55346-0943-1
Package Description: 497 g in 1 BOTTLE
Product Details
What is NDC 55346-0943?
What are the uses for Alpha-pro?
What are Alpha-pro Active Ingredients?
- HYDROFLUORIC ACID 4.4 mg/g - Hydrofluoric acid. A solution of hydrogen fluoride in water. It is a colorless fuming liquid which can cause painful burns.
- SODIUM FLUORIDE 7.9 mg/g - A source of inorganic fluoride which is used topically to prevent dental caries.
Which are Alpha-pro UNII Codes?
The UNII codes for the active ingredients in this product are:
- SODIUM FLUORIDE (UNII: 8ZYQ1474W7)
- FLUORIDE ION (UNII: Q80VPU408O) (Active Moiety)
- HYDROFLUORIC ACID (UNII: RGL5YE86CZ)
What is the NDC to RxNorm Crosswalk for Alpha-pro?
- RxCUI: 1297381 - hydrofluoric acid 1 % / phosphoric acid 1.12 % / sodium fluoride 1.8 % Oral Gel
- RxCUI: 1297381 - hydrofluoric acid 0.01 MG/MG / phosphoric acid 0.0112 MG/MG / sodium fluoride 0.018 MG/MG Oral Gel
* Please review the disclaimer below.
[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.
[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
[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.
[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.
[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.
[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".