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Cloveden 100 times higher concentrated Cetylpyridinium Chloride 2.29 g/100mL Mouthwash — NDC 84516-0040-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Cloveden 100 times higher concentrated Cetylpyridinium Chloride 2.29 g/100mL Mouthwash — NDC 84516-040-02 (Billing 84516-0040-02)

by Acuseplanet Inc · 1 BOTTLE in 1 CARTON / 50 mL in 1 BOTTLE

This is a package of Cloveden 100 times higher concentrated Cetylpyridinium Chloride 2.29 g/100mL Mouthwash from Acuseplanet Inc, marketed since Aug 2025 and currently FDA-listed. It is this product's only package size.

NDC 84516-0040-02
🏷️ FDA NDC (as labeled) 84516-040-02 billing pads the product segment with a zero
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 84516-040-02 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
84516 labeler · 040 product · 02 package
Package marketed since
Aug 1, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 8451604002 7
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) 84516-040-02
Product NDC 84516-040
11-digit billing NDC 84516004002
RxCUI 2590919
UNII D9OM4SK49P
Application # M021
SPL Set ID 3c0e1862-293f-4d23-e063-6294a90a33e1
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-08-01
Route ORAL
Dosage form MOUTHWASH
Substance CETYLPYRIDINIUM CHLORIDE
Quick answers
  • RxCUI (RxNorm): 2590919
Why two NDCs? The FDA registers this code as 84516-040-02 — 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 → 84516-0040-02. 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.

Clinical

🧪 What is this product?

Cloveden is an over-the-counter mouthwash containing cetylpyridinium chloride, an antimicrobial ingredient. This mouthwash is marketed under FDA's standard rule-book for over-the-counter oral rinses rather than as an individually reviewed drug application. Cetylpyridinium chloride is commonly used in oral care products to help reduce bacteria in the mouth. The product is used as a rinse by mouth.

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 eachPer 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
84516-0040-02 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 50 mL in 1 BOTTLE 2025-08-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cloveden 100 times higher concentrated 2.29 g/100mL 73242-1115-02 DONG 1 bottle — — FDA listed —
Cool Sense Concentrated 2.296 g/100mL 73242-1125-02 DONG 50 ml — — FDA listed —
Double X CONCENTRATED 2.3 g/100mL 76670-0012-02 DOCSMEDI 30 ml — — FDA listed —
Cool Sense Concentrated 2.296 g/100mL 76670-0017-02 DOCSMEDI 50 ml — — FDA listed —
Cloveden 100 times higher concentrated 2.29 g/100mLthis 84516-0040-02 Acuseplanet 1 bottle — — 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
Aug 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.

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 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 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 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • 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.

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

The official label also statesInactive ingredients Water, Propylene Glycol, PEG-40 Hydrogenated Castor Oil, Glycerin, Sodium Saccharin, Sodium Citrate, Herb-Mint Flavor, Menthol, Mentha Piperita Oil, Xylitol, Sucralose, Citric Acid, Melaleuca Alternifolia Leaf Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Aloe Barbadensis Leaf Extract, Chamomilla Recutita Flower Extract, Eucalyptus Globulus Leaf Extract, Camellia Sinensis Leaf Extract, Brilliant Blue FCF

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

LabelerAcuseplanet Inc
FDA applicationM021 (OTC MONOGRAPH DRUG)
Labeler code84516
First marketedAug 2025
Product typeHuman Otc Drug
Portfolio2 products on file

More NDCs from Acuseplanet Inc labeler code 84516

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 15 words ▾

Use(s) ■ Refreshing the mouth ■ Plaque removal ■ Oral cleanliness ■ Bad breath removal

⏱️ Dosage and Administration 94 words ▾

Directions Adults and children 6 years of age and older: ■ use twice a day after brushing your teeth with a toothpaste ■ vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out ■ do not swallow the rinse ■ do not eat or drink for 30 minutes after rinsing ■ instruct children under 12 years of age in good rinsing habits (to minimize swallowing) ■supervise children as necessary until capable of using without supervision Children under 6 years of age: consult a dentist or doctor

⚠️ Warnings 22 words ▾

Warnings ■ If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 5 words ▾

Active ingredient(s) Cetylpyridinium Chloride 2.296%

🧪 Inactive Ingredients 52 words ▾

Inactive ingredients Water, Propylene Glycol, PEG-40 Hydrogenated Castor Oil, Glycerin, Sodium Saccharin, Sodium Citrate, Herb-Mint Flavor, Menthol, Mentha Piperita Oil, Xylitol, Sucralose, Citric Acid, Melaleuca Alternifolia Leaf Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Aloe Barbadensis Leaf Extract, Chamomilla Recutita Flower Extract, Eucalyptus Globulus Leaf Extract, Camellia Sinensis Leaf Extract, Brilliant Blue FCF

🎯 Purpose 2 words ▾

Purpose Antiplaque

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children

📄 Other Information 23 words ▾

Other Information ■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light

📄 Questions or Comments 8 words ▾

Questions ■ https://acuseplanet.cafe24.com/shop2/ ■ Customer center : 82-70-8065-7737

📄 Package Label / Principal Display Panel 2 words ▾

Carton Image

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

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 Acuseplanet Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Acuseplanet Inc 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.
← 84516-0030-02 · Acuseplanet 84517-0032-01 · Zhejiang →
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.