TheraBreath Healthy Gums CETYLPYRIDINIUM CHLORIDE .01 mg/20mL Rinse, 473 mL
by Church & Dwight Co., Inc. · 473 mL in 1 BOTTLE, PLASTIC (10237-258-16)
NDC 10237-0258-16
🏷️ FDA NDC (as labeled)
10237-258-16
billing pads the product segment with a zero
This package
Contains473 mL
Pack sizes6 compare ↓
Also comes in:
2 bottles 10237-0258-21
2 bottles 10237-0258-26
88.7 ml 10237-0258-03
296 ml 10237-0258-10
1000 ml 10237-0258-01
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)
10237-258-16
Product NDC
10237-258
11-digit billing NDC
10237025816
UNII
D9OM4SK49P
UPC
0697029996010
Application #
505G(a)(3)
SPL Set ID
e06bfc9e-38e5-475b-89c1-026ccfe56031
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2023-02-13
Route
ORAL
Dosage form
RINSE
Substance
CETYLPYRIDINIUM CHLORIDE
Why two NDCs?
The FDA registers this code as 10237-258-16 — 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 → 10237-0258-16. 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.
🏭 Manufacturer & labeler
LabelerChurch & Dwight Co., Inc.
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code10237
First marketedFeb 2023
Product typeHuman Otc Drug
Portfolio156 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?
TheraBreath Healthy Gums is an over-the-counter oral rinse containing cetylpyridinium chloride, a compound commonly used in mouth rinses as an antimicrobial agent. This product is marketed under the FDA's OTC monograph rules for oral antiseptic rinses. Cetylpyridinium chloride is typically included in rinses intended to reduce bacteria in the mouth.
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
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 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 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.
4 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesWater, Glycerin, Poloxamer 407, Flavor, Sucralose
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
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 |
|---|---|---|---|---|---|---|
| TheraBreath Healthy Gums .01 mg/20mLthis 10237-0258-16 | Church | 473 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
🏛️
2023
On the market since
Feb 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.
🔬 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 Therabreath Healthy Gums (this brand).
Top reported reactions
Reporter sex
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 |
|---|---|---|---|
| 10237-0258-01 | 1000 mL in 1 BOTTLE, PLASTIC (10237-258-01) | 2023-02-13 | Active |
| 10237-0258-03 | 88.7 mL in 1 BOTTLE, PLASTIC (10237-258-03) | 2023-02-13 | Active |
| 10237-0258-16 You're viewing this | 473 mL in 1 BOTTLE, PLASTIC (10237-258-16) | 2023-02-13 | Active |
| 10237-0258-10 | 296 mL in 1 BOTTLE, PLASTIC (10237-258-10) | 2025-12-23 | Active |
| 10237-0258-21 | 2 BOTTLE, PLASTIC in 1 PACKAGE (10237-258-21) / 1000 mL in 1 BOTTLE, PLASTIC | 2025-03-31 | Active |
| 10237-0258-26 | 2 BOTTLE, PLASTIC in 1 BOX (10237-258-26) / 473 mL in 1 BOTTLE, PLASTIC | 2024-02-01 | Active |
Pack size FAQ
What quantity is in NDC 10237-0258-16?
NDC 10237-0258-16 contains 473 mL — 473 ml in 1 bottle, plastic.
What is the difference between NDC 10237-0258-16 and NDC 10237-0258-03?
Both are TheraBreath Healthy Gums CETYLPYRIDINIUM CHLORIDE .01 mg/20mL Rinse — the drug itself is identical. NDC 10237-0258-16 is the 473 mL package, while NDC 10237-0258-03 is the 88.7 ml package.
What NDC number is used to bill for this package of TheraBreath Healthy Gums CETYLPYRIDINIUM CHLORIDE .01 mg/20mL Rinse?
Bill NDC 10237-0258-16 — the 11-digit billing format is 10237025816. 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 10237-258-16, 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: 10237-0258-16, written without dashes as 10237025816. 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 10237-0258-16, the first segment (10237) is the labeler code FDA assigned to Church & Dwight Co., Inc.; the middle segment (0258) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (16) 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 Church & Dwight Co., Inc.. 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 5 other package presentations of this same product, including 2 bottles (10237-0258-21), 2 bottles (10237-0258-26), 88.7 ml (10237-0258-03). 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?
Church & Dwight Co., Inc. 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 ▾
Uses Helps prevent • gingivitis, an early form of gum disease • bleeding gums Helps control plaque that leads to • gingivitis • bleeding gums
⏱️ Dosage and Administration ▾
Directions Adults and Children 12 years and older Vigorously swish 20 milliliters (4 teaspoonfuls) 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 Supervise use. Children under 6 years Do not use.
⚠️ Warnings ▾
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 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.
📦 Storage and Handling ▾
Other information This rinse is not intended to replace brushing or flossing.
🧪 Active Ingredient ▾
Active Ingredients Cetylpyridinium Chloride 0.05%
🧪 Inactive Ingredients ▾
Inactive Ingredients Water, Glycerin, Poloxamer 407, Flavor, Sucralose
🎯 Purpose ▾
Purpose 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.