NDC 52083-713 Gumsol

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
52083-713
Proprietary Name:
Gumsol
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Kramer Novis
Labeler Code:
52083
Start Marketing Date: [9]
02-28-2014
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Packages

NDC Code 52083-713-01

Package Description: 30 mL in 1 BOTTLE

Product Details

What is NDC 52083-713?

The NDC code 52083-713 is assigned by the FDA to the product Gumsol which is product labeled by Kramer Novis. The product's dosage form is . The product is distributed in a single package with assigned NDC code 52083-713-01 30 ml in 1 bottle . 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 Gumsol?

Other information Phenylketonurics: Contains phenylalanine 2.5 mg/mLStore at controlled room temperature 15-30°C (59-86°F).Tamper Evident Feature: Do not use if imprinted foil seal over bottle opening is torn, broken, or missing.

Which are Gumsol UNII Codes?

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

Which are Gumsol 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 Gumsol?

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: 485560 - benzocaine 5 % / zinc chloride 0.1 % Mucous Membrane Topical Solution
  • RxCUI: 485560 - benzocaine 50 MG/ML / zinc chloride 1 MG/ML Mucous Membrane Topical Solution

* 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".