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  4. NDC Product Code: 36800-710 Bismuth Subsalicylate

NDC 36800-710 Bismuth Subsalicylate

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 36800-710?
  5. Bismuth Subsalicylate Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing expired due to lack of listing certification.

Get all the details for National Drug Code (NDC) 36800-710 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
36800-710
Proprietary Name:
Bismuth Subsalicylate
Product Type: [3]
Labeler Name: [5]
Topco Associates Llc
Labeler Code:
36800
Product Label ID:
629c1b69-9554-415d-9e48-3651838ab78c
FDA Application Number: [6]
M008
Marketing Category: [8]
OTC MONOGRAPH DRUG -
Start Marketing Date: [9]
02-19-2021
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
U
Code Navigator:

Product Characteristics

Color(s):
PINK (C48328)
Shape:
OVAL (C48345)
Size(s):
21 MM
Imprint(s):
262
Score:
1

Code Structure Chart

Product Details

What is NDC 36800-710?

The NDC code 36800-710 is assigned by the FDA to the product Bismuth Subsalicylate which is product labeled by Topco Associates Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 36800-710-24 2 blister pack in 1 carton / 12 capsule, gelatin coated in 1 blister pack. 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 Bismuth Subsalicylate?

 swallow with water, do not chew adults and children 12 years and over: 2 softgels every ½ hour or 4 softgels every hour as needed for diarrhea  2 softgels every ½ hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)  do not exceed 8 doses (16 softgels) in 24 hours use until diarrhea stops but not more than 2 days children under 12 years: ask a doctor drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Which are Bismuth Subsalicylate UNII Codes?

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

Which are Bismuth Subsalicylate 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 Bismuth Subsalicylate?

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 code indicates a single concept unique identifier (RXCUI) is associated with this product:

* Please review the disclaimer below.

Patient Education

Bismuth Subsalicylate


Bismuth subsalicylate is used to treat diarrhea, heartburn, and upset stomach in adults and children 12 years of age and older. Bismuth subsalicylate is in a class of medications called antidiarrheal agents. It works by decreasing the flow of fluids and electrolytes into the bowel, reduces inflammation within the intestine, and may kill the organisms that can cause diarrhea.
[Learn More]


* 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.

[6] 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.

[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, 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".