Nicotine Gum Gum, Chewing
NDC Package 87494-002-01

11-digit billing NDC: 87494000201
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Nicotine Gum (nicotine polacrilex) gums is if you are under 18 years of age, ask a doctor before usebefore using this product, read the enclosed User’s Guide for complete directions and other important informationbegin using the gum on your quit dayif you smoke your first cigarette more than 30 minutes after waking up, use Nicotine Polacrilex Gum, 4 mgyour first cigarette within 30 minutes of waking up, use Nicotine Polacrilex Gum, 4 mg according to the following 12 week schedule:Weeks 1–6 Weeks 7–9 Weeks 10–12 1 piece every 1 to 2 hours 1 piece every 2 to 4 hours 1 piece every 4 to 8 hours nicotine gum is a medicine and must be used a certain way to get the best resultschew the gum slowly until it tingles. This formulation utilizes a gum, chewing delivery system. Marketed by Guangzhou Shuimu Jiahe Trading Co., Ltd., this product is identified by NDC 87494-002 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
87494-002-01
Package Description
48 mg in 1 BOX, UNIT-DOSE
Product Code
87494-002
11-Digit Billing Format
87494000201

Clinical Specifications

Proprietary Name
Nicotine Gum
Non-Proprietary Name
Nicotine Polacrilex
Substance Name
Nicotine
Dosage Form
Gum, Chewing - A sweetened and flavored insoluble plastic material of various shapes which when chewed, releases a drug substance into the oral cavity.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
NICOTINE 4 mg/1000mg
Pharmacologic Class
Usage Information
If you are under 18 years of age, ask a doctor before usebefore using this product, read the enclosed User’s Guide for complete directions and other important informationbegin using the gum on your quit dayif you smoke your first cigarette more than 30 minutes after waking up, use Nicotine Polacrilex Gum, 4 mgyour first cigarette within 30 minutes of waking up, use Nicotine Polacrilex Gum, 4 mg according to the following 12 week schedule:Weeks 1–6 Weeks 7–9 Weeks 10–12 1 piece every 1 to 2 hours 1 piece every 2 to 4 hours 1 piece every 4 to 8 hours nicotine gum is a medicine and must be used a certain way to get the best resultschew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns.repeat this process until most of the tingle is gone (about 30 minutes)do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a pieceto improve your chances of quitting, use at least 9 pieces per day for the first 6 weeksif you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects.do not use more than 24 pieces a day

Regulatory & Marketing

Labeler Name
Guangzhou Shuimu Jiahe Trading Co., Ltd.
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-03-2026
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 87494-002-01 identifies a specific commercial package of 48 mg in 1 box, unit-dose of Nicotine Gum, a human over the counter drug labeled by Guangzhou Shuimu Jiahe Trading Co., Ltd.. This gum, chewing 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 April 03, 2026. The current certification is valid through December 31, 2027.

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: 87494000201. 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)
87494-002-01
11-Digit CMS (5-4-2)
87494-0002-01

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