Bismuth Subsalicylate Liquid
NDC Package 81033-046-34

11-digit billing NDC: 81033004634
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Bismuth Subsalicylate liquids is shake well before useadults and children 12 years and over:30 mL (1 dose) every 1/2 hour or 60 mL (2 doses) every hour as needed fordiarrhea/traveler’s diarrhea30 mL (1 dose) every 1/2 hour as needed for overindulgence (upset stomach,heartburn, indigestion, nausea)do not exceed 8 doses (240 mL) in 24 hoursuse until diarrhea stops but no more than 2 dayschildren under 12 years: ask a doctor drink plenty of clear fluids to help prevent dehydration caused by diarrhea. This formulation utilizes a liquid delivery system. Marketed by Kesin Pharma, this product is identified by NDC 81033-046 and is authorized under FDA application M008.

Identification & Billing

NDC Package Code
81033-046-34
Package Description
30 CUP, UNIT-DOSE in 1 CARTON / 15 mL in 1 CUP, UNIT-DOSE (81033-046-15)
Product Code
81033-046
11-Digit Billing Format
81033004634

Clinical Specifications

Proprietary Name
Bismuth Subsalicylate
Non-Proprietary Name
Bismuth Subsalicylate
Substance Name
Bismuth Subsalicylate
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
BISMUTH SUBSALICYLATE 525 mg/30mL
Usage Information
Shake well before useadults and children 12 years and over:30 mL (1 dose) every 1/2 hour or 60 mL (2 doses) every hour as needed fordiarrhea/traveler’s diarrhea30 mL (1 dose) every 1/2 hour as needed for overindulgence (upset stomach,heartburn, indigestion, nausea)do not exceed 8 doses (240 mL) in 24 hoursuse until diarrhea stops but no 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
Kesin Pharma
Product Type
Human Otc Drug
FDA Application #
M008
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-03-2025
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 81033-046-34 identifies a specific commercial package of 30 cup, unit-dose in 1 carton / 15 ml in 1 cup, unit-dose (81033-046-15) of Bismuth Subsalicylate, a human over the counter drug labeled by Kesin Pharma. This liquid 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 Kesin Pharma on February 03, 2025. The current certification is valid through December 31, 2027.

How is this Kesin Pharma product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81033004634. 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)
81033-046-34
11-Digit CMS (5-4-2)
81033-0046-34

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