Parodontax Gum Strengthen and Protect cetylpyridinium chloride .7 mg/mL Rinse, 500 mL
by Haleon US Holdings LLC · 500 mL in 1 BOTTLE (0135-0654-01)
NDC 00135-0654-01
🏷️ FDA NDC (as labeled)
0135-0654-01
billing pads the labeler segment with a zero
This package
Contains500 mL
Pack sizes2 compare ↓
Also comes in:
1000 ml 00135-0654-02
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 →
⚠️
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)
0135-0654-01
Product NDC
0135-0654
11-digit billing NDC
00135065401
RxCUI
1100924
UNII
D9OM4SK49P
Application #
M022
SPL Set ID
3bb378c8-14b2-aa13-e063-6294a90a4db3
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2026-01-05
Route
ORAL
Dosage form
RINSE
Substance
CETYLPYRIDINIUM CHLORIDE
Why two NDCs?
The FDA registers this code as 0135-0654-01 — a 4-4-2 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 labeler segment → 00135-0654-01. 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
LabelerHaleon US Holdings LLC
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code00135
First marketedJan 2026
Product typeHuman Otc Drug
Portfolio404 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?
Parodontax Gum Strengthen and Protect is an oral rinse containing cetylpyridinium chloride, an antimicrobial agent commonly used in over-the-counter oral care products. This product is marketed as an OTC monograph drug, meaning it follows established FDA guidelines for its category rather than undergoing individual review. Cetylpyridinium chloride is typically used to help reduce bacteria in the mouth and is found in many rinses designed to support gum health and oral hygiene.
Patient education
Supplement & herbal interactions
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.
💬 Questions about cetylpyridinium chloride?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
blue
FlavorMint
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.
🧪 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 92N74OA24D
A synthetic dye used to color medicines blue. It helps manufacturers identify the product and make tablets or capsules visually distinctive for recognition purposes.
-
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 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 YSE9PPT4TH
Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
-
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 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 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.
9 inactive ingredients listed in the exact product block matched to this NDC.
The official label also stateswater, glycerin, propylene glycol, poloxamer 407, flavor, benzoic acid, sodium benzoate, sodium saccharin, sucralose, sodium hyaluronate, 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.
💲 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 system | Per each | Per 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.
Try another pack size:
1000 ml
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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/mLthis 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/mL 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
🏛️
2026
On the market since
Jan 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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 Parodontax Gum Strengthen and Protect (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 32%
Female · 68%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00135-0654-01 You're viewing this | 500 mL in 1 BOTTLE (0135-0654-01) | 2026-01-05 | Active |
| 00135-0654-02 | 1000 mL in 1 BOTTLE (0135-0654-02) | 2026-01-05 | Active |
You're viewing the smallest of 2 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 00135-0654-01?
NDC 00135-0654-01 contains 500 mL — 500 ml in 1 bottle.
What is the difference between NDC 00135-0654-01 and NDC 00135-0654-02?
Both are Parodontax Gum Strengthen and Protect cetylpyridinium chloride .7 mg/mL Rinse — the drug itself is identical. NDC 00135-0654-01 is the 500 mL package, while NDC 00135-0654-02 is the 1000 ml package.
What NDC number is used to bill for this package of Parodontax Gum Strengthen and Protect cetylpyridinium chloride .7 mg/mL Rinse?
Bill NDC 00135-0654-01 — the 11-digit billing format is 00135065401. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
🧭 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 FDA registers it as 0135-0654-01, 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: 00135-0654-01, written without dashes as 00135065401. 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 00135-0654-01, the first segment (00135) is the labeler code FDA assigned to Haleon US Holdings LLC; the middle segment (0654) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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: this package is listed as actively marketed, with no marketing end date reported by Haleon US Holdings LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1000 ml (00135-0654-02). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Haleon US Holdings 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
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses helps prevent and reduce plaque that leads to gingivitis, an early form of gum disease bleeding gums
⏱️ Dosage and Administration ▾
Directions adult and children 6 years of age and older: measure twice up to 10 milliliters mark inside of cap. Vigorously swish 20 milliliters of the rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse. Do not rinse with water. Do not drink from the bottle. children 6 years to under 12 years of age: supervise use children under 6 years of age: do not use
⚠️ Warnings ▾
Warnings Stop use and ask a dentist if irritation occurs 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 space between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease. 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.
🧪 Active Ingredient ▾
Active ingredient Cetylpyridinium chloride 0.07% w/w
🧪 Inactive Ingredients ▾
Inactive ingredients water, glycerin, propylene glycol, poloxamer 407, flavor, benzoic acid, sodium benzoate, sodium saccharin, sucralose, sodium hyaluronate, blue 1
🎯 Purpose ▾
Purposes Antigingivitis, Antiplaque
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.