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Antigingivitis/Antiplaque Cetylpyridinium Chloride .5 mg/mL Mouthwash, 1000 mL — NDC 76162-953-86 (Billing 76162-0953-86)

by Topco Associates LLC · 1000 mL in 1 BOTTLE, PLASTIC

This is a package of 1,000 mL of Antigingivitis/Antiplaque Cetylpyridinium Chloride .5 mg/mL Mouthwash from Topco Associates LLC, marketed since Apr 2024 and currently FDA-listed. It is this product's only package size.

NDC 76162-0953-86
🏷️ FDA NDC (as labeled) 76162-953-86 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 76162-953-86 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
76162 labeler · 953 product · 86 package
Package marketed since
Apr 18, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 7616295386 8
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) 76162-953-86
Product NDC 76162-953
11-digit billing NDC 76162095386
RxCUI 1251617
UNII D9OM4SK49P
Application # M505G(a)(3)
SPL Set ID 3fefe9b3-d61d-494d-bd85-5d2cf8321398
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-04-18
Route ORAL
Dosage form MOUTHWASH
Substance CETYLPYRIDINIUM CHLORIDE
Quick answers
  • RxCUI (RxNorm): 1251617
Why two NDCs? The FDA registers this code as 76162-953-86 — 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 → 76162-0953-86. 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, a chemical that functions as an antimicrobial agent. Products of this type are commonly used as oral rinses to help reduce bacteria in the mouth and are typically marketed to support gum health and reduce plaque buildup. The mouthwash is applied by rinsing in the mouth and is sold under FDA's standard rules for over-the-counter oral care products.

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
76162-0953-86 You're viewing this Main listing 1000 mL in 1 BOTTLE, PLASTIC 2024-04-18 — 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/mL 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/mLthis 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

🏛️
2024
On the market since
Apr 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 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 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 H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • 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 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 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.

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

The official label also stateswater, alcohol (15 wt%), propylene glycol, flavor, poloxamer 407, sucralose, benzoic acid, sodium benzoate, cinnamal, blue 1, yellow 6

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

LabelerTopco Associates LLC
FDA applicationM505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code76162
First marketedApr 2024
Product typeHuman Otc Drug
Portfolio408 products on file

More NDCs from Topco Associates LLC labeler code 76162

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 📄 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 26 words ▾

Adverse reaction DISTRIBUTED BY TOPCO ASSOCIATES LLC, ITASCA, IL 60143 ©TOPCO VIJA1123 QUESTIONS? 1-888-423-0139 [email protected] www.topcarebrand.com Scan here for more information or call 1-888-423-0139 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.

📄 Other Information 10 words ▾

Tamper Evident Statement SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

📄 Questions or Comments 3 words ▾

Questions? Call 1-888-423-0139

📄 Package Label / Principal Display Panel 54 words ▾

Principal Panel Display COMPARE TO CREST ® PRO-HEALTH ® INTENSE CLEAN MINT MOUTHWASH* TopCare ® everyday Powerful Fresh Antigingivitis/Antiplaque Mouthwash FRESH MINT Kills 99% of many bad breath germs** Freshens your breath Helps prevent plaque and gingivitis IMPORTANT: Read directions for proper use. 1 L (1.05 QT)

33.8 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 — 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 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 Topco Associates LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Topco Associates 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.
← 76162-0947-34 · Topco 76162-0957-21 · Topco →
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.