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anzoon ANTIBACTERIAL MOUTH WASH Cetylpyridinium Chloride .027 g/100mL Liquid, 300 mL — NDC 87638-0002-06 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

anzoon ANTIBACTERIAL MOUTH WASH Cetylpyridinium Chloride .027 g/100mL Liquid, 300 mL — NDC 87638-002-06 (Billing 87638-0002-06)

by Shandong AZC Biotechnology Co.,Ltd. · 300 mL in 1 BOTTLE

This is a package of 300 mL of anzoon ANTIBACTERIAL MOUTH WASH Cetylpyridinium Chloride .027 g/100mL Liquid from Shandong AZC Biotechnology Co.,Ltd., marketed since Apr 2026 and currently FDA-listed.

NDC 87638-0002-06
🏷️ FDA NDC (as labeled) 87638-002-06 billing pads the product segment with a zero
This package
Contains300 mL Pack sizes8 compare ↓
Product page 87638-0002-01 Also comes in: 10 ml 87638-002-01 15 ml 87638-002-02 60 ml 87638-002-03 100 ml 87638-002-04 260 ml 87638-002-05 500 ml 87638-002-07 1000 ml 87638-002-08
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 87638-002-06 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
87638 labeler · 002 product · 06 package
Package marketed since
Apr 28, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8763800206 5
FDA record last changed
Jul 24, 2026
⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 87638-002-06
Product NDC 87638-002
11-digit billing NDC 87638000206
RxCUI 2741388
UNII D9OM4SK49P
Application # M021
SPL Set ID 507c6896-2806-790c-e063-6394a90ac5ce
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-04-28
Route TOPICAL
Dosage form LIQUID
Substance CETYLPYRIDINIUM CHLORIDE
Quick answers
  • RxCUI (RxNorm): 2741388
Why two NDCs? The FDA registers this code as 87638-002-06 — 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 → 87638-0002-06. 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.

Clinical

🧪 What is this product?

Anzoon Antibacterial Mouth Wash is an over-the-counter liquid rinse for oral use. It contains cetylpyridinium chloride, an antimicrobial agent commonly used in oral care products to help reduce bacteria in the mouth. This type of mouth rinse is typically used as part of daily oral hygiene routines. The product is marketed under FDA's over-the-counter monograph rules for antiseptic rinses.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

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.
Try another pack size: 10 ml 15 ml 60 ml 100 ml 260 ml 500 ml 1000 ml
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
87638-0002-01 87638-002-01 Main listing 10 mL in 1 BOTTLE 2026-04-28 — Active
87638-0002-02 87638-002-02 15 mL in 1 BOTTLE 2026-04-28 — Active
87638-0002-03 87638-002-03 60 mL in 1 BOTTLE 2026-04-28 — Active
87638-0002-04 87638-002-04 100 mL in 1 BOTTLE 2026-04-28 — Active
87638-0002-05 87638-002-05 260 mL in 1 BOTTLE 2026-04-28 — Active
87638-0002-06 You're viewing this 300 mL in 1 BOTTLE 2026-04-28 — Active
87638-0002-07 87638-002-07 500 mL in 1 BOTTLE 2026-04-28 — Active
87638-0002-08 87638-002-08 1000 mL in 1 BOTTLE 2026-04-28 — Active

You're viewing one of 8 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 300 mL — 300 ml in 1 bottle.
How does this package differ from NDC 87638-0002-01?
Both are anzoon ANTIBACTERIAL MOUTH WASH Cetylpyridinium Chloride .027 g/100mL Liquid — the drug itself is identical. This page's package is the 300 mL one, while NDC 87638-0002-01 is the 10 ml package.
What NDC number is used to bill for this package of anzoon ANTIBACTERIAL MOUTH WASH Cetylpyridinium Chloride .027 g/100mL Liquid?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
anzoon ANTIBACTERIAL MOUTH WASH .027 g/100mLthis 87638-0002-06 Shandong 300 ml — — 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

🏛️
2026
On the market since
Apr 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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.

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 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 56687D1Z4D
    A natural plant extract from pomegranate fruit, used as a flavor and color ingredient to enhance taste and appearance in medicines.
  • UNII 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • 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 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 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.
  • UNII VCQ006KQ1E
    Xylitol is a naturally occurring sugar alcohol derived from plants. It's used in medicines as a sweetener, bulking agent, and to improve taste, especially in liquid formulations and chewable tablets.

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

The official label also statesWater, sorbitol, Potassium Sorbate, Sodium Benzoate, Xylitol, Menthol,Pomegranate Extract

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 DailyMed — ingredient 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.

Manufacturer & labeler

LabelerShandong AZC Biotechnology Co.,Ltd.
FDA applicationM021 (OTC MONOGRAPH DRUG)
Labeler code87638
First marketedApr 2026
Product typeHuman Otc Drug

More NDCs from Shandong AZC Biotechnology Co.,Ltd. labeler code 87638

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.

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 ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 4 words ▾

Uses Antigingivitis, Antiplaque, Anti-caries

⏱️ Dosage and Administration 50 words ▾

Directions 1.Pour the anzoon Gargle & Mouthwash into the cup 20 ml 2. Swish part of the solution briefly in mouth and s[it it out 3. Tilt head back, gargle for 30 seconds at the throat and spit it out 4. Repeated every two to four hours or as directed

⚠️ Warnings 61 words ▾

Warnings For external use only When using this product Avoided in: 1 Thyroid disorders 2. Pregnant/Breastfeeding Used only upon advice by healthcare professional Stop use and ask a doctor Stop use and ask a doctor if irritation or rash appears and lasts. Keep out of reach of children If swallowed, get medical help, or contact a Poison COntrol Center right away.

📦 Storage and Handling 12 words ▾

Other information Store between 15-30 ºC(59-86°F) Do not store above 100 °F(43°C)

🧪 Active Ingredient 5 words ▾

Active ingredient Cetylpyridinium Chloride 0.027%

🧪 Inactive Ingredients 11 words ▾

Inactive ingredients Water, sorbitol, Potassium Sorbate, Sodium Benzoate, Xylitol, Menthol,Pomegranate Extract

🎯 Purpose 3 words ▾

Purpose Oral Antibacterial

📄 When Using This Product 18 words ▾

When using this product Avoided in: 1 Thyroid disorders 2. Pregnant/Breastfeeding Used only upon advice by healthcare professional

📄 Stop Use and Ask a Doctor If 19 words ▾

Stop use and ask a doctor Stop use and ask a doctor if irritation or rash appears and lasts.

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children If swallowed, get medical help, or contact a Poison COntrol Center right away.

📄 Package Label / Principal Display Panel 4 words ▾

Label label label label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 anzoon ANTIBACTERIAL MOUTH WASH (this brand).

Top reported reactions

Nausea21
Vomiting17
Fatigue15
Back Pain14
Sepsis14
Pain13
Rash12

Age at onset

Adolescent2
Adult20
Elderly29

Reporter sex

169 reports
Male · 28%
Female · 72%

Serious outcomes

Hospitalization100
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.

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 ✓ Available
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Shandong AZC Biotechnology Co.,Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 7 other package presentations of this same product, including 10 ml (87638-0002-01), 15 ml (87638-0002-02), 60 ml (87638-0002-03). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Shandong AZC Biotechnology 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.
← 87638-0001-01 · Shandong 87640-0001-01 · Ningbo →
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.