Topcare Stomach Relief
NDC Package 76162-023-04

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Topcare Stomach Relief is shake well before usemL = milliliterTBSP = tablespoonadults and children 12 years and over: 1 dose (2 TBSP or 30 mL) every 1/2 to 1 hour as neededdo not exceed 8 doses (16 TBSP or 240 mL) in 24 hoursuse until diarrhea stops but not more than 2 dayschildren under 12 years: ask a doctordrink plenty of fluids to help prevent dehydration caused by diarrhea. Marketed by Topco Associates, Llc, this product is identified by NDC 76162-023 and is authorized under FDA application part335.

Identification & Billing

NDC Package Code
76162-023-04
Package Description
236 mL in 1 BOTTLE
Product Code
76162-023
11-Digit Billing Format
76162002304
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
Dosage Form
-
Usage Information
Shake well before usemL = milliliterTBSP = tablespoonadults and children 12 years and over: 1 dose (2 TBSP or 30 mL) every 1/2 to 1 hour as neededdo not exceed 8 doses (16 TBSP or 240 mL) in 24 hoursuse until diarrhea stops but not more than 2 dayschildren under 12 years: ask a doctordrink plenty of fluids to help prevent dehydration caused by diarrhea

Regulatory & Marketing

Labeler Name
Topco Associates, Llc
FDA Application #
part335
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
01-05-2021
Listing Expiration
12-31-2024
Exclude Flag
I
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 (76162-023). Click a package code to view its specific billing and regulatory data.

76162-023-05
354 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 76162-023-04 identifies a specific commercial package of 236 ml in 1 bottle of Topcare Stomach Relief, labeled by Topco Associates, Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Topco Associates, Llc on January 05, 2021. The current certification is valid through December 31, 2024.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76162002304. 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)
76162-023-04
11-Digit CMS (5-4-2)
76162-0023-04

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