Nicotine Oral Pouch Lozenge
NDC Package 87494-001-02

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

Package Information

Nicotine Oral Pouch (nicotine) lozenges is this medication can help you quit smoking by replacing the nicotine in cigarettes. This formulation utilizes a lozenge delivery system. Marketed by Guangzhou Shuimu Jiahe Trading Co., Ltd., this product is identified by NDC 87494-001 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
87494-001-02
Package Description
3 BOX, UNIT-DOSE in 1 BOX / 45 mg in 1 BOX, UNIT-DOSE (87494-001-01)
Product Code
87494-001
11-Digit Billing Format
87494000102

Clinical Specifications

Proprietary Name
Nicotine Oral Pouch
Non-Proprietary Name
Nicotine
Substance Name
Nicotine
Dosage Form
Lozenge - A solid preparation containing one or more medicaments, usually in a flavored, sweetened base which is intended to dissolve or disintegrate slowly in the mouth. A lollipop is a lozenge on a stick.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
NICOTINE 8 mg/1000mg
Pharmacologic Class
Usage Information
This medication can help you quit smoking by replacing the nicotine in cigarettes. The nicotine in tobacco is an important part of cigarette addiction. When you stop smoking, your nicotine levels drop quickly. This drop can cause withdrawal symptoms such as craving tobacco, nervousness, irritability, headache, weight gain, and difficulty concentrating. Stopping smoking is hard and your chance of success is best when you are ready and have made a commitment to quit. Nicotine replacement products are part of a total stop-smoking program that includes behavior change, counseling, and support. Smoking causes lung disease, cancer, and heart disease. Stopping smoking is one of the most important things you can do to improve your health and live longer.

Regulatory & Marketing

Labeler Name
Guangzhou Shuimu Jiahe Trading Co., Ltd.
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-08-2026
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 87494-001-02 identifies a specific commercial package of 3 box, unit-dose in 1 box / 45 mg in 1 box, unit-dose (87494-001-01) of Nicotine Oral Pouch, a human over the counter drug labeled by Guangzhou Shuimu Jiahe Trading Co., Ltd.. This lozenge is formulated for oral use and contains nicotine 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 Guangzhou Shuimu Jiahe Trading Co., Ltd. on March 08, 2026. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication can help you quit smoking by replacing the nicotine in cigarettes. The nicotine in tobacco is an important part of cigarette addiction. When you stop smoking, your nicotine levels drop quickly. This drop can cause withdrawal symptoms such as craving tobacco, nervousness, irritability, headache, weight gain, and difficulty concentrating. Stopping smoking is hard and your chance of success is best when you are ready and have made a commitment to quit. Nicotine replacement products are part of a total stop-smoking program that includes behavior change, counseling, and support. Smoking causes lung disease, cancer, and heart disease. Stopping smoking is one of the most important things you can do to improve your health and live longer.

How is this Guangzhou Shuimu Jiahe Trading Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 87494000102. 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)
87494-001-02
11-Digit CMS (5-4-2)
87494-0001-02

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