Seavue Anti-caries Gel
NDC Package 87118-004-01

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

Package Information

Seavue Anti-caries Gel (sodium fluoride) gel is directions Tray Method: Rinse mouth and clean teeth before use. This formulation utilizes a gel delivery system. Marketed by Xiling (zhenjiang) Medical Technology Co., Ltd., this product is identified by NDC 87118-004 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
87118-004-01
Package Description
1 g in 1 BOX
Product Code
87118-004
11-Digit Billing Format
87118000401

Clinical Specifications

Proprietary Name
Seavue Anti-caries Gel
Non-Proprietary Name
Sodium Fluoride
Substance Name
Sodium Fluoride
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route
Dental - Administration to a tooth or teeth.
Active Ingredient(s)
SODIUM FLUORIDE 1.36 mg/g
Usage Information
Directions Tray Method: Rinse mouth and clean teeth before use. Fill dental tray evenly with gel and place over dental arch. Leave in place for 5 minutes. Remove tray, spit out gel, and rinse mouth thoroughly. Brush Method:Apply a small amount of gel evenly to teeth using a toothbrush or cotton swab. Leave on for 3–5 minutes. Rinse mouth thoroughly.

Regulatory & Marketing

Labeler Name
Xiling (zhenjiang) Medical Technology Co., Ltd.
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-08-2025
Listing Expiration
12-31-2026
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 87118-004-01 identifies a specific commercial package of 1 g in 1 box of Seavue Anti-caries Gel, a human over the counter drug labeled by Xiling (zhenjiang) Medical Technology Co., Ltd.. This gel is formulated for dental use and contains sodium fluoride 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 Xiling (zhenjiang) Medical Technology Co., Ltd. on October 08, 2025. The current certification is valid through December 31, 2026.

How is this Xiling (zhenjiang) Medical Technology Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 87118000401. 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)
87118-004-01
11-Digit CMS (5-4-2)
87118-0004-01

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