Topcare Stomach Relief Suspension
NDC Package 36800-341-12

11-digit billing NDC: 36800034112
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Topcare Stomach Relief (bismuth subsalicylate) suspension is shake well before useOnly use dose cup providedadults and children 12 years and over:15 mL (1 dose) every 1/2 or 30 mL (2 doses) every hour as needed for diarrhea/traveler’s diarrhea. This formulation utilizes a suspension delivery system. Marketed by Topco Associates Llc, this product is identified by NDC 36800-341 and is authorized under FDA application M008.

Identification & Billing

NDC Package Code
36800-341-12
Package Description
354 mL in 1 BOTTLE
Product Code
36800-341
11-Digit Billing Format
36800034112
RxNorm Crosswalk
  • RxCUI: 308763 - bismuth subsalicylate 1050 MG in 30 mL Oral Suspension
  • RxCUI: 308763 - bismuth subsalicylate 35 MG/ML Oral Suspension
  • RxCUI: 308763 - bismuth subsalicylate 1050 MG per 30 ML Oral Suspension
  • RxCUI: 308763 - bismuth subsalicylate 525 MG per 15 ML Oral Suspension

Clinical Specifications

Proprietary Name
Topcare Stomach Relief Ultra Strength
Non-Proprietary Name
Bismuth Subsalicylate
Substance Name
Bismuth Subsalicylate
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
BISMUTH SUBSALICYLATE 525 mg/15mL
Pharmacologic Class
Usage Information
Shake well before useOnly use dose cup providedadults and children 12 years and over:15 mL (1 dose) every 1/2 or 30 mL (2 doses) every hour as needed for diarrhea/traveler’s diarrhea. 15 mL (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)do not exceed 8 doses (120 mL) in 24 hoursuse until diarrhea stops but not more than 2 dayschildren under 12 years:ask a doctor drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Regulatory & Marketing

Labeler Name
Topco Associates Llc
Product Type
Human Otc Drug
FDA Application #
M008
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-14-2019
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (36800-341). Click a package code to view its specific billing and regulatory data.

36800-341-08
236 mL in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 36800-341-12 identifies a specific commercial package of 354 ml in 1 bottle of Topcare Stomach Relief Ultra Strength, a human over the counter drug labeled by Topco Associates Llc. This suspension is formulated for oral use and contains bismuth subsalicylate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Topco Associates Llc on March 14, 2019. The current certification is valid through December 31, 2026.

How is this Topco Associates Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36800034112. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
36800-341-12
11-Digit CMS (5-4-2)
36800-0341-12

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.