Pink Bismuth
NDC 67510-0505

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 67510-0505?
  4. Pink Bismuth 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.

Pink Bismuth is a OTC MONOGRAPH FINAL-approved product labeled by Kareway Product, Inc.. This medication is used to treat occasional upset stomach, heartburn, and nausea. It is supplied as a product. This product entry covers the primary NDC 67510-0505 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
67510-0505
Proprietary Name:
Pink Bismuth
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Kareway Product, Inc.
Labeler Code:
67510
Product Label ID:
cdc53b63-b013-4f89-844e-db95b06ba41b
FDA Application Number: [6]
part335
Marketing Category: [8]
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.

Marketing Timeline

Start Marketing Date: [9]
08-29-2011
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I

Code Structure Chart

Product Details

What is NDC 67510-0505?

The NDC code 67510-0505 is assigned by the FDA to the product Pink Bismuth. This pharmaceutical product is labeled by Kareway Product, Inc. and is currently categorized as listed product. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 67510-0505-4, 67510-0505-6. 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?

This medication is used to treat occasional upset stomach, heartburn, and nausea. It is also used to treat diarrhea and help prevent travelers' diarrhea. It works by helping to slow the growth of bacteria that might be causing the diarrhea. This product should not be used to self-treat diarrhea if you also have a fever or blood/mucus in the stools. These could be signs of a serious health condition. Consult your doctor promptly for proper evaluation and treatment if you have these symptoms. This medication is used under a doctor's direction with other medication to treat stomach ulcers caused by a certain bacteria (Helicobacter pylori). Do not use this medication to self-treat ulcers. Bismuth subsalicylate is a salicylate. Salicylates can cause serious bleeding problems when used alone in patients with ulcers. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

Which are the associated UNII Codes?

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

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:

What is the NDC to RxNorm Crosswalk for this product?

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: 308762 - bismuth subsalicylate 525 MG in 30 mL Oral Suspension
  • RxCUI: 308762 - bismuth subsalicylate 17.5 MG/ML Oral Suspension
  • RxCUI: 308762 - bismuth subsalicylate 1.75 % Oral Suspension
  • RxCUI: 308762 - bismuth subsalicylate 262 MG per 15 ML Oral Suspension
  • RxCUI: 308762 - bismuth subsalicylate 524 MG per 30 ML Oral Suspension

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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 FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
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".