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Antigingivitis/Antiplaque Cetylpyridinium Chloride .5 mg/mL Mouthwash, 1000 mL — NDC 59450-953-86 (Billing 59450-0953-86)

by The Kroger Co. · 1000 mL in 1 BOTTLE, PLASTIC

This is a package of 1,000 mL of Antigingivitis/Antiplaque Cetylpyridinium Chloride .5 mg/mL Mouthwash from The Kroger Co., marketed since Nov 2023 and currently FDA-listed. It is this product's only package size.

NDC 59450-0953-86
🏷️ FDA NDC (as labeled) 59450-953-86 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 59450-953-86 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
59450 labeler · 953 product · 86 package
Package marketed since
Nov 13, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5945095386 3
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) 59450-953-86
Product NDC 59450-953
11-digit billing NDC 59450095386
RxCUI 1251617
UNII D9OM4SK49P
Application # 505G(a)(3)
SPL Set ID 0e61d4a1-0b81-4bca-bdb3-b9927278b769
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-11-13
Route ORAL
Dosage form MOUTHWASH
Substance CETYLPYRIDINIUM CHLORIDE
Quick answers
  • RxCUI (RxNorm): 1251617
Why two NDCs? The FDA registers this code as 59450-953-86 — 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 → 59450-0953-86. 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 containing cetylpyridinium chloride 0.5 mg/mL. The product is marketed under FDA's monograph rule for oral rinses in this category. Cetylpyridinium chloride is an antimicrobial agent typically used in oral care products to help reduce bacteria in the mouth. This mouthwash is labeled for antigingivitis and antiplaque use, meaning it is intended to help address gum inflammation and plaque buildup.

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
59450-0953-86 You're viewing this Main listing 1000 mL in 1 BOTTLE, PLASTIC 2023-11-13 — Active

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/mLthis 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/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

🏛️
2023
On the market since
Nov 2023
📍
2026
Currently FDA-listed
3 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerThe Kroger Co.
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code59450
First marketedNov 2023
Product typeHuman Otc Drug
Portfolio96 products on file

More NDCs from The Kroger Co. labeler code 59450

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 📄 Questions or Comments 📄 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 38 words ▾

Adverse Reaction PROUDLY DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202 MADE IN USA WITH DOMESTIC AND FOREIGN COMPONENTS QUALITY GUARANTEED Kroger.com/guarantee 800-632-6900 FOR MORE PRODUCT INFORMATION, SCAN UPC USING YOUR KROGER APP OR CALL 800-632-6900 DSP-TN-21091 DSP-MO-20087

🧪 Active Ingredient 5 words ▾

Active Ingredient Cetylpyridinium Chloride 0.05%

🧪 Inactive Ingredients 21 words ▾

Inactive ingredients water, alcohol (15 wt%), propylene glycol, flavor, poloxamer 407, sucralose, benzoic acid, sodium benzoate, cinnamal, blue 1, yellow 6

🎯 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.

📄 Questions or Comments 5 words ▾

Questions or Comments? Call 1-800-632-6900

📄 Package Label / Principal Display Panel 80 words ▾

Principal Panel Display COMPARE TO the active ingredient in CREST ® PRO-HEALTH ® INTENSE CLEAN MINT MOUTHWASH *See Back Label Kroger ® INTENSE ANTIGINGIVITIS/ANTIPLAQUE MOUTHWASH COOLING SENSATION POWERFUL FRESH MINT KILLS 99% OF GERMS† FRESHENS BREATH HELPS KEEP TEETH CLEAN PARABEN-FREE COOLING HELPS PREVENT PLAQUE & GINGIVITIS SUGAR FREE †Kills at least 99% of many organisms commonly assoicated with bad breath in as little as 15 seconds QUALITY GUARANTEED

33.8FL OZ (1.5 QT) 1 L 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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 The Kroger Co.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
The Kroger Co. 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.
← 59450-0947-30 · The 59450-0971-86 · The →
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.