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Cepacol Antibacterial Cetylpyridinium chloride .05 g/100mL Liquid

by Reckitt Benckiser LLC · 1 BOTTLE in 1 CARTON (63824-790-80) / 710 mL in 1 BOTTLE
NDC 63824-0790-80
🏷️ FDA NDC (as labeled) 63824-790-80 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 →

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

FDA NDC (as labeled) 63824-790-80
Product NDC 63824-790
11-digit billing NDC 63824079080
NCPDP billing unit ML — per mL (volume)
RxCUI 1251617, 1251619
UNII D9OM4SK49P
Application # 505G(a)(3)
SPL Set ID 7c19eba6-3ebd-497f-9066-6152b72eafdd
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-06-22
Marketing end 2027-09-03
Route ORAL
Dosage form LIQUID
Substance CETYLPYRIDINIUM CHLORIDE
GPI-14 88300009100910
GPI class Cepacol Antibacterial
Why two NDCs? The FDA registers this code as 63824-790-80 — 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 → 63824-0790-80. 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

LabelerReckitt Benckiser LLC
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code63824
First marketedJun 2011
Product typeHuman Otc Drug
Portfolio174 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?

Cepacol Antibacterial is an over-the-counter oral liquid rinse marketed under FDA monograph rules for antiseptic mouth rinses. The active ingredient, cetylpyridinium chloride, is an antimicrobial agent commonly used in oral rinses to reduce bacteria in the mouth and throat. This product is typically used as a rinse or gargle to help with minor mouth and throat irritation. Cetylpyridinium chloride functions as an antimicrobial that disrupts bacterial cell membranes.

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.

🧪 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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII E5GY4I6YCZ
    A fragrant liquid extracted from cinnamon bark, used as a flavoring agent to improve the taste of medicines and make them more pleasant to take.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII 2R04ONI662
    Eucalyptus oil is a fragrant liquid extracted from eucalyptus tree leaves. It's used in medicines as a flavor, scent, or soothing agent in topical products and cough preparations.
  • UNII I753WB2F1M
    FD&C Yellow No. 5 is a synthetic yellow colorant approved by the FDA. It is added to medicines to make pills, tablets, or liquids visually distinct and easier to identify.
  • 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 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 LAV5U5022Y
    Methyl salicylate is a naturally derived liquid compound commonly found in wintergreen plants. In medicines, it's used as a flavoring agent and penetrating solvent to help distribute active ingredients evenly throughout topical products.
  • UNII AV092KU4JH
    A natural oil extracted from peppermint plants. It's used as a flavoring agent to mask bitter tastes and add a refreshing mint flavor to medicines, making them easier to take.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • 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 GR686LBA74
    Sodium phosphate, dibasic is a salt derived from phosphoric acid. It acts as a buffer to help maintain the medicine's pH balance and may serve as a binder or filler in tablets and capsules.
  • UNII KH7I04HPUU
    A salt compound made from sodium and phosphoric acid, used as a buffer to help maintain a stable pH level in the medicine, and sometimes as a binder or filler in tablets and capsules.
  • 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, alcohol 14% v/v, glycerin, sodium phosphate dibasic, eucalyptus oil, polysorbate 80, methyl salicylate, cinnamon oil, peppermint oil, saccharin sodium, sodium phosphate monobasic anhydrous, menthol, edetate disodium, FD&C Yellow #5

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.

💲 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/100mLthis 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/100mg 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

🏛️
2011
On the market since
Jun 2011
📍
2026
Currently FDA-listed
15 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.

🔬 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 Cetylpyridinium chloride — the ingredient across all brands.

Top reported reactions

Dyspnoea50
Nausea45
Pain41
Fatigue40
Cough33
Vomiting32
Ageusia31

Reporter sex

647 reports

Serious outcomes

Death72
Life-threatening45
Disabling36
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 59 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
63824-0790-80 You're viewing this 1 BOTTLE in 1 CARTON (63824-790-80) / 710 mL in 1 BOTTLE 2011-06-22 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 63824-790-80, 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: 63824-0790-80, written without dashes as 63824079080. 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 63824-0790-80, the first segment (63824) is the labeler code FDA assigned to Reckitt Benckiser LLC; the middle segment (0790) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (80) 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 it is currently marketed — but Reckitt Benckiser LLC has reported a marketing end date of 2027-09-03, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Who lists this product with the FDA?
Reckitt Benckiser 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.

📄 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
🎯 Indications and Usage 18 words ▾

Uses helps prevent and reduce plaque that leads to: gingivitis, an early form of gum disease bleeding gums

⏱️ Dosage and Administration 54 words ▾

Directions adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse children 6 years to under 12 years of age: supervise use children under 6 years of age: do not use.

⚠️ Warnings 83 words ▾

Warnings 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 increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease. Keep out of the 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.

📦 Storage and Handling 21 words ▾

Other Information this rinse is not intended to replace brushing or flossing store at room temperature 20-25°C (68-77°F) protect from humidity

🧪 Active Ingredient 5 words ▾

Active ingredient Cetylpyridinium chloride 0.05%

🧪 Inactive Ingredients 33 words ▾

Inactive ingredients purified water, alcohol 14% v/v, glycerin, sodium phosphate dibasic, eucalyptus oil, polysorbate 80, methyl salicylate, cinnamon oil, peppermint oil, saccharin sodium, sodium phosphate monobasic anhydrous, menthol, edetate disodium, FD&C Yellow #5

🎯 Purpose 2 words ▾

Purpose Antigingivitis/Antiplaque

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 63824-0744-16 · Reckitt 63824-0794-99 · RB →
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.