NDC 87118-006 Esunix Oral Bacteriostatic Gel

Cetylpyridinium Chloride Gel, Dentifrice Dental - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

Get all the details for National Drug Code (NDC) 87118-006 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
87118-006
Proprietary Name:
Esunix Oral Bacteriostatic Gel
Non-Proprietary Name: [1]
Cetylpyridinium Chloride
Substance Name: [2]
Cetylpyridinium Chloride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Gel, Dentifrice - A combination of a dentifrice (formulation intended to clean and/or polish the teeth, and which may contain certain additional agents), and a gel. It is used with a toothbrush for the purpose of cleaning and polishing the teeth.
Administration Route(s): [4]
Dental - Administration to a tooth or teeth.
Labeler Code:
87118
FDA Application Number: [6]
M022
Marketing Category: [8]
OTC MONOGRAPH DRUG -
Start Marketing Date: [9]
09-21-2025
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
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Product Details

What is NDC 87118-006?

The NDC code 87118-006 is assigned by the FDA to the product Esunix Oral Bacteriostatic Gel which is a human over the counter drug product labeled by Xiling (zhenjiang) Medical Technology Co., Ltd.. The generic name of Esunix Oral Bacteriostatic Gel is cetylpyridinium chloride. The product's dosage form is gel, dentifrice and is administered via dental form. The product is distributed in a single package with assigned NDC code 87118-006-02 10 tube in 1 box / 1 g in 1 tube (87118-006-01). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Esunix Oral Bacteriostatic Gel?

Adults and children 6 years and older: Apply a small amount of gel to the gums and teeth using a cotton swab or clean finger. Allow it to remain in place for at least 30 minutes before rinsing, eating, or drinking. Children under 6 years: Use only under the supervision of a dentist or physician.For post-procedure care (tooth extraction, implant), follow dentist's instructions.

What are Esunix Oral Bacteriostatic Gel Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • CETYLPYRIDINIUM CHLORIDE .06 g/100g - Cationic bactericidal surfactant used as a topical antiseptic for skin, wounds, mucous membranes, instruments, etc.; and also as a component in mouthwash and lozenges.

What is the NDC to RxNorm Crosswalk for Esunix Oral Bacteriostatic Gel?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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Product Footnotes

[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".