HomeNDC LookupIngredientsCetylpyridinium Chloride › 87118-0005-02
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Esunix Oral Bacteriostatic Liquid Cetylpyridinium chloride .05 mg/100mg Liquid, 12 mg

by Xiling (Zhenjiang) Medical Technology Co., Ltd. · 1 BOX, UNIT-DOSE in 1 BOX (87118-005-02) / 12 mg in 1 BOX, UNIT-DOSE (87118-005-01)
NDC 87118-0005-02
🏷️ FDA NDC (as labeled) 87118-005-02 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Cetylpyridinium Chloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · Dec 26, 2025 — Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles. (Haleon US Holdings LLC) · FDA recall D-0297-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 87118-005-02
Product NDC 87118-005
11-digit billing NDC 87118000502
RxCUI 1251617
UNII D9OM4SK49P
Application # M022
SPL Set ID 3f47d7e1-b6ae-efd1-e063-6394a90a4602
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-09-21
Route DENTAL
Dosage form LIQUID
Substance CETYLPYRIDINIUM CHLORIDE
Why two NDCs? The FDA registers this code as 87118-005-02 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 87118-0005-02. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Antiinfectives class.

Drug family (ATC) Antiinfectives, Quaternary ammonium compounds, Medicated dressings with antiinfectives
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerXiling (Zhenjiang) Medical Technology Co., Ltd.
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code87118
First marketedSep 2025
Product typeHuman Otc Drug
Portfolio4 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

🧪 What is this product?

Esunix Oral Bacteriostatic Liquid is an over-the-counter dental rinse containing cetylpyridinium chloride, an antimicrobial agent. This product is marketed under the FDA's OTC monograph rules for oral care products. Cetylpyridinium chloride is typically used in oral rinses and lozenges to help reduce bacteria in the mouth and throat. This liquid form is applied by rinsing or gargling as directed on the label.

Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII W2ZU1RY8B0
    A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability during storage.
  • UNII G7LK3FFB99
    A synthetic or natural mint-flavored fragrance ingredient used to add pleasant taste and aroma to medicines. It helps mask bitter flavors and makes the medication more palatable, especially in liquid or chewable formulations.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 42B5YD8F0K
    A plant extract from licorice root used in traditional medicine. In formulations, it may serve as a flavoring agent, sweetener, or soothing ingredient to improve taste and texture.
  • UNII 4465L2WS4Y
    A plant extract from Japanese honeysuckle flowers used as a natural flavoring and fragrance ingredient in medicines. It may also help preserve the product and add pleasant taste or aroma.
  • UNII L7T10EIP3A
    A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
  • UNII 7YC686GQ8F
    A synthetic oily substance made from castor oil. It works as a solubilizer and emulsifier to help mix oily and water-based ingredients together in the medicine.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII A78OOO9299
    A plant extract from flowering cherry blossoms used as a natural colorant and flavor agent in medicines to improve appearance and taste.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

14 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesPurified water, Sorbitol, PEG-40 hydrogenated castor oil, Glycerin, Propylparaben, Fragrance, Sodium benzoate, Lonicera japonica flower extract, Prunus speciosa flower extract, Glycyrrhiza uralensis extract, Camellia sinensis polyphenols, Sodium citrate, Menthol, Sucralose.

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cetylpyridinium Chloride .5 mg/mL 00363-9542-43 Walgreen 473 ml FDA listed
Antiseptic Oral Rinse .5 mg/mL 53462-0175-60 Sage 7 ml FDA listed
Antiplaque solution .5 mg/mL 53462-0275-60 Sage 7 ml FDA listed
Corinz .5 mg/mL 53462-0375-07 Sage 7 ml FDA listed
Cetylpyridinium Chloride .5 mg/mL 56062-0542-43 Publix 473 ml FDA listed
Antigingivitis/Antiplaque .5 mg/mL 59450-0953-86 The 1000 ml FDA listed
Cepacol Antibacterial .05 g/100mL 63824-0790-80 Reckitt 1 bottle FDA listed
Crest Pro-Health Bacteria Guard .05 g/mL 69423-0905-10 The 1000 ml FDA listed
Brush Buddies Oral Rinse Clean Mint .5 mg/mL 70108-0164-01 Ashtel 473 ml FDA listed
Brush Buddies oral rinse - healthy gums .05 g/100mL 70108-0278-01 Ashtel 473 ml FDA listed
GuruNanda Anti-Gingivitis .05 g/mL 70708-0012-16 GURUNANDA, 473 ml FDA listed
twice. Oral Wellness Gum Shield .5 mg/mL 72164-0009-20 Twice 591 ml FDA listed
Antigingivitis/Antiplaque .5 mg/mL 76162-0953-86 Topco 1000 ml FDA listed
Cool Sense Stick Gargle .05 g/100mL 76670-0015-02 DOCSMEDI 10 ml FDA listed
Antigingivitis/Antiplaque .5 mg/mL 79481-0953-01 Meijer, 1000 ml FDA listed
Target Up And Up Gum Care .05 g/100mL 82442-0104-16 Target 473 ml FDA listed
Equate Healthy Gums Clean Mint Breath Oral Rinse .5 mg/mL 84239-0000-00 Vasu 475 ml FDA listed
Esunix Oral Bacteriostatic Liquid .05 mg/100mgthis 87118-0005-02 Xiling 12 mg FDA listed
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2025
On the market since
Sep 2025
📍
2026
Currently FDA-listed
1 year listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Esunix Oral Bacteriostatic Liquid (this brand).

Top reported reactions

Nausea21
Vomiting17
Fatigue15
Back Pain14
Sepsis14
Pain13
Rash12

Reporter sex

0 reports

Serious outcomes

Death25
Life-threatening19
Disabling4
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 19 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
87118-0005-02 You're viewing this 1 BOX, UNIT-DOSE in 1 BOX (87118-005-02) / 12 mg in 1 BOX, UNIT-DOSE (87118-005-01) 2025-09-21 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 87118-005-02, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 87118-0005-02, written without dashes as 87118000502. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 87118-0005-02, the first segment (87118) is the labeler code FDA assigned to Xiling (Zhenjiang) Medical Technology Co., Ltd.; the middle segment (0005) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Xiling (Zhenjiang) Medical Technology Co., Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Xiling (Zhenjiang) Medical Technology Co., Ltd. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 14 words

Helps reduce bacteria in the mouth that may cause bad breath and oral discomfort.

⏱️ Dosage and Administration 44 words

Adults and children 6 years and older: Use after brushing. Tear open one pouch and pour into mouth. Gargle for 20 seconds, then spit out. Do not rinse with water. Children under 6 years: Use only under the supervision of a dentist or physician.

⚠️ Warnings 66 words

For oral use only. Do not swallow. Accidental ingestion of small amounts is not expected to cause harm. Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Stop use and ask a doctor if irritation or allergic reaction occurs. Keep out of reach of children. If more than used for rinsing is swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 4 words

Cetylpyridinium chloride 0.05% (w/w)

🧪 Inactive Ingredients 30 words

Purified water, Sorbitol, PEG-40 hydrogenated castor oil, Glycerin, Propylparaben, Fragrance, Sodium benzoate, Lonicera japonica flower extract, Prunus speciosa flower extract, Glycyrrhiza uralensis extract, Camellia sinensis polyphenols, Sodium citrate, Menthol, Sucralose.

🎯 Purpose 2 words

Oral antiseptic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.