NDC 62942-101 Debacterol Canker Sore Pain Relief

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:
62942-101
Proprietary Name:
Debacterol Canker Sore Pain Relief
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Labeler Code:
62942
Start Marketing Date: [9]
09-01-1996
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
BROWN (C48332 - DARK)

Code Structure Chart

Product Details

What is NDC 62942-101?

The NDC code 62942-101 is assigned by the FDA to the product Debacterol Canker Sore Pain Relief which is product labeled by Epien Medical Inc. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 62942-101-03 1 vial, glass in 1 box / 1.5 ml in 1 vial, glass, 62942-101-12 12 applicator in 1 box / .2 ml in 1 applicator (62942-101-02). 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 Debacterol Canker Sore Pain Relief?

Debacterol is indicated in the topical treatment of ulcerating lesions of the oral cavity such as Recurrent Aphthous Stomatitis (Canker Sores). Debacterol provides relief from the pain and discomfort of oral mucosal ulcers. Debacterol is not intended for the treatment of vesicular lesions, such as Cold Sores or Fever Blisters.

Which are Debacterol Canker Sore Pain Relief UNII Codes?

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

Which are Debacterol Canker Sore Pain Relief 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 Debacterol Canker Sore Pain Relief?

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: 1245974 - sulfonated phenol 50 % / sulfuric acid 30 % Medicated Pad
  • RxCUI: 1245974 - sulfonated phenol 500 MG/ML / sulfuric acid 300 MG/ML Medicated Pad
  • RxCUI: 1245974 - sulfonated phenol 50 % / sulfuric acid 30 % Dental Swab
  • RxCUI: 1369589 - Debacterol 50 % / 30 % Medicated Pad
  • RxCUI: 1369589 - sulfonated phenol 500 MG/ML / sulfuric acid 300 MG/ML Medicated Pad [Debacterol]

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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".