Stomach Relief, Maximum Strength Suspension
NDC Package 76281-558-25

11-digit billing NDC: 76281055825
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Stomach Relief, Maximum Strength (bismuth subsalicylate) suspension is uses relieves ■ travelers' diarrhea ■ diarrhea■ upset stomach due to overindulgence of food and drinkincluding: ■ heart burn ■ indigestion ■ nausea ■ gas■ belching. This formulation utilizes a suspension delivery system. Marketed by Aptapharma Inc., this product is identified by NDC 76281-558 and is authorized under FDA application M008.

Identification & Billing

NDC Package Code
76281-558-25
Package Description
177 mL in 1 BOTTLE
Product Code
76281-558
11-Digit Billing Format
76281055825
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
Stomach Relief, Maximum 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 1050 mg/30mL
Usage Information
Uses relieves ■ travelers' diarrhea ■ diarrhea■ upset stomach due to overindulgence of food and drinkincluding: ■ heart burn ■ indigestion ■ nausea ■ gas■ belching

Regulatory & Marketing

Labeler Name
Aptapharma Inc.
Product Type
Human Otc Drug
FDA Application #
M008
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-30-2020
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 76281-558-25 identifies a specific commercial package of 177 ml in 1 bottle of Stomach Relief, Maximum Strength, a human over the counter drug labeled by Aptapharma Inc.. 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 Aptapharma Inc. on September 30, 2020. The current certification is valid through December 31, 2027.

How is this Aptapharma Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76281055825. 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)
76281-558-25
11-Digit CMS (5-4-2)
76281-0558-25

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