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Antigingivitis/Antiplaque Cetylpyridinium Chloride .7 mg/mL Mouthwash, 500 mL — NDC 11344-0900-77 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Antigingivitis/Antiplaque Cetylpyridinium Chloride .7 mg/mL Mouthwash, 500 mL — NDC 11344-900-77 (Billing 11344-0900-77)

by Nice-Pak Products, LLC · 500 mL in 1 BOTTLE, PLASTIC

This is a package of 500 mL of Antigingivitis/Antiplaque Cetylpyridinium Chloride .7 mg/mL Mouthwash from Nice-Pak Products, LLC, marketed since May 2024 and currently FDA-listed. It is this product's only package size.

NDC 11344-0900-77
🏷️ FDA NDC (as labeled) 11344-900-77 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 Sep 3, 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

⚠️
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) 11344-900-77
Product NDC 11344-900
11-digit billing NDC 11344090077
RxCUI 1100924
UNII D9OM4SK49P
Application # 505G(a)(3)
SPL Set ID a66d8d21-1ebf-45e6-97bd-dbe17ee67162
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-05-01
Route ORAL
Dosage form MOUTHWASH
Substance CETYLPYRIDINIUM CHLORIDE
Quick answers
  • RxCUI (RxNorm): 1100924
Why two NDCs? The FDA registers this code as 11344-900-77 — 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 → 11344-0900-77. 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?

This is an over-the-counter mouthwash product containing cetylpyridinium chloride at 0.7 mg per mL. Cetylpyridinium chloride is commonly used in oral rinses as an antimicrobial agent to help reduce bacteria in the mouth. This product is marketed under FDA's over-the-counter monograph rules for antigingivitis and antiplaque mouthwashes and is meant to be rinsed in the mouth and spit out after use.

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
11344-0900-77 You're viewing this Main listing 500 mL in 1 BOTTLE, PLASTIC 2024-05-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Parodontax Active Gum Health Clear Mint .7 mg/mL 00135-0650-01 Haleon 500 ml — — FDA listed —
Parodontax Active Gum Health Mint 70 mg/mL 00135-0651-02 Haleon 500 ml — — FDA listed —
Parodontax Gum Strengthen and Protect .7 mg/mL 00135-0654-01 Haleon 500 ml — — FDA listed —
Health .7 mg/mL 00363-0099-86 Walgreen 1000 ml — — FDA listed —
Antiseptic .7 mg/mL 11344-0299-77 Nice-Pak 500 ml — — FDA listed —
Antigingivitis/Antiplaque .7 mg/mLthis 11344-0900-77 Nice-Pak 500 ml — — FDA listed —
Antiseptic .7 mg/mL 11673-0299-12 Target 1500 ml — — Discontinued —
Alcohol Free Antiseptic .7 mg/mL 11822-5761-02 Rite 1000 ml — — FDA listed —
Mint .7 mg/mL 21130-0299-86 Better 1000 ml — — FDA listed —
Antiseptic .7 mg/mL 36800-0299-21 Topco 89 ml — — Discontinued —
Crest Pro-Health Multi-Protection Refreshing Clean Mint .014 g/20mL 37000-0451-01 The 36 ml — — FDA listed —
Alcohol Free .7 mg/mL 37808-0299-86 H 1000 ml — — FDA listed —
Equaline Multi-Action Antiseptic .7 mg/mL 41163-0299-86 United 1000 ml — — FDA listed —
Mint .7 mg/mL 41250-0826-86 Meijer, 1000 ml — — FDA listed —
Multi-Action Antiseptic .7 mg/mL 41520-0299-86 American 1000 ml — — FDA listed —
Antiseptic .7 mg/mL 49035-0299-12 Walmart 1500 ml — — Discontinued —
Antiseptic .7 mg/mL 50804-0299-86 Perrigo 1000 ml — — FDA listed —
Antispetic .7 mg/mL 53942-0299-86 Demoulas 1000 ml — — FDA listed —
Antiseptic .7 mg/mL 55301-0299-86 Your 1000 ml — — FDA listed —
Health .7 mg/mL 55910-0299-86 Old 1000 ml — — FDA listed —
Zestymint Antiseptic .7 mg/mL 56062-0299-15 Publix 1000 ml — — FDA listed —
Antigingivitis/Antiplaque .7 mg/mL 59450-0997-86 The 1000 ml — — FDA listed —
CVS Antiseptic .7 mg/mL 59779-0299-21 CVS 89 ml — — Discontinued —
Antiseptic .7 mg/mL 63941-0299-86 Valu 1000 ml — — FDA listed —
Mint Alcohol Free .7 mg/mL 67091-0462-33 WinCo 1000 ml — — FDA listed —
Crest Pro Health .014 g/20mL 67751-0186-01 Navajo 36 ml — — FDA listed —
PerCara Oral Health Rinse Fresh Mint .07 g/100mL 67933-0321-01 LEC 500 ml — — FDA listed —
Oral B Plaque Defense Special Care Oral Rinse .07 g/mL 69423-0855-16 The 475 ml — — FDA listed —
Crest Pro-Health Advantage .07 g/mL 69423-0893-33 The 1000 ml — — Discontinued —
Oral B Gum Detoxify Special Care Rinse .07 g/mL 69423-0906-16 The 475 ml — — FDA listed —
Multi-Action Antiseptic .7 mg/mL 72288-0299-86 Amazon.com 1000 ml — — FDA listed —
Antigingivitis/Antiplaque .7 mg/mL 76162-0090-86 Topco 1000 ml — — FDA listed —
Antigingivitis/Antiplaque .7 mg/mL 79481-0900-01 Meijer, 1000 ml — — FDA listed —
Crest Pro-Health Gum DetoxifyWinter Mint .07 g/mL 84126-0648-01 The 1000 ml — — FDA listed —
Crest Pro-Health Gum Restore Smooth Mint .014 g/20mL 84126-0649-01 The 1000 ml — — FDA listed —
Crest Pro-Health Nightly Bacteria Shield .07 g/mL 84126-0650-01 The 1000 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

🏛️
2024
On the market since
May 2024
📍
2026
Currently FDA-listed
2 years 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 8SKN0B0MIM
    Benzoic acid is a naturally occurring organic acid used as a preservative in medicines and foods. It helps prevent bacterial and fungal growth to extend shelf life and maintain product stability.
  • UNII SR60A3XG0F
    Cinnamal is a fragrant organic compound derived from cinnamon oil. It's used in medicines as a flavoring agent and fragrance to make the product taste or smell more pleasant.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • 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 TUF2IVW3M2
    Poloxamer 407 is a synthetic polymer made from ethylene oxide and propylene oxide. In medicines, it acts as a thickener, emulsifier, and solubilizer to help mix ingredients and create the right texture.
  • UNII SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • 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 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.
  • UNII 2GXR25858Y
    Zinc lactate is a salt compound combining zinc and lactic acid. It serves as a mineral supplement ingredient and buffering agent that helps maintain the medicine's pH and stability.

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

The official label also stateswater, glycerin, flavor, zinc lactate, benzoic acid, sodium saccharin, sucralose, sodium benzoate, poloxamer 407, cinnamal, blue 1

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

LabelerNice-Pak Products, LLC
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code11344
First marketedMay 2024
Product typeHuman Otc Drug
Portfolio45 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.

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 🤒 Adverse Reactions 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 8 words ▾

Use helps control plaque that leads to gingivitis

⏱️ Dosage and Administration 52 words ▾

Directions adults and children 6 years & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day do not swallow children 6 years to under 12 years of age: supervise use when used after brushing, rinse mouth with water first children under 6 years of age: do not use

⚠️ Warnings 4 words ▾

Warnings For this product

🤒 Adverse Reactions 13 words ▾

Adverse reaction Distributed by: Consumer Product Partners, LLC St. Louis, MO 63114 1-888-593-0593

🧪 Active Ingredient 5 words ▾

Active Ingredient Cetylpyridinium Chloride 0.07%

🧪 Inactive Ingredients 19 words ▾

Inactive ingredients water, glycerin, flavor, zinc lactate, benzoic acid, sodium saccharin, sucralose, sodium benzoate, poloxamer 407, cinnamal, blue 1

🎯 Purpose 3 words ▾

Purpose Antigingivitis, Antiplaque

📄 Stop Use and Ask a Doctor If 50 words ▾

Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

📄 Keep Out of Reach of Children 31 words ▾

Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

📄 Other Information 10 words ▾

Tamper evident statement SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

📄 Package Label / Principal Display Panel 47 words ▾

Principal display panel SWAN ® COMPARE TO Crest ® Pro Health ® * $1.25 GUM DEFENSE MOUTHWASH ANTIGINGIVITIS/ANTIPLAQUE SMOOTH MINT Helps reduce early signs of gum disease Kills the germs that cause bad breath Alcohol free 500 mL (1.05 PT)

16.9 FL OZ image description image description

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 Antigingivitis/Antiplaque (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

Death25
Life-threatening19
Disabling4
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 34 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 Nice-Pak Products, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Nice-Pak Products, LLC 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.
← 11344-0894-18 · Nice-Pak 11344-0943-34 · Nice-Pak →
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.