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  4. NDC Product Code: 50438-303 Amber Mouth Rinse

NDC 50438-303 Amber Mouth Rinse

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 50438-303?
  4. Amber Mouth Rinse Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
50438-303
Proprietary Name:
Amber Mouth Rinse
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Filo America
Labeler Code:
50438
Product Label ID:
45cd7964-2520-48f2-8155-35467b8f49f0
Start Marketing Date: [9]
07-30-2013
Listing Expiration Date: [11]
12-31-2019
Exclude Flag: [12]
I
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Product Details

What is NDC 50438-303?

The NDC code 50438-303 is assigned by the FDA to the product Amber Mouth Rinse which is product labeled by Filo America. The product's dosage form is . The product is distributed in a single package with assigned NDC code 50438-303-01 500 ml in 1 bottle, plastic . 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 Amber Mouth Rinse?

ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER.VIGOROUSLY SWISH 20 ML (2/3 FLUID OUNCE OR 4 TEASPOONFULS) BETWEEN TEETH FOR 30 SECONDS THEN SPI9T OUT;DO NOT SWALLOW.CHILDREN UNDER 12 YEARS OF AGE, CONSULT A DENTIST OR DOCTOR.THIS RINSE IS NOT INTENDED TO REPLACE BRUSHING OR FLOSSING.

Which are Amber Mouth Rinse UNII Codes?

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

Which are Amber Mouth Rinse 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 Amber Mouth Rinse?

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: 1043619 - eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % Mouthwash
  • RxCUI: 1043619 - eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash

* Please review the disclaimer below.

Product Footnotes

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

[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".