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Corinz Cetylpyridinium Chloride .5 mg/mL Rinse, 7 mL — NDC 53462-0375-07 package photo

Corinz Cetylpyridinium Chloride .5 mg/mL Rinse, 7 mL

by Sage Products, LLC · 7 mL in 1 CUP (53462-375-07)
NDC 53462-0375-07
🏷️ FDA NDC (as labeled) 53462-375-07 billing pads the product segment with a zero
This package
Contains7 mL Pack sizes3 compare ↓
Also comes in: 7 ml 53462-0375-60 44 ml 53462-0375-30
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) 53462-375-07
Product NDC 53462-375
11-digit billing NDC 53462037507
RxCUI 1251617
UNII D9OM4SK49P
Application # M022
SPL Set ID 685b6023-89c4-417e-af2d-52e831855da1
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-01-20
Route ORAL
Dosage form RINSE
Substance CETYLPYRIDINIUM CHLORIDE
Why two NDCs? The FDA registers this code as 53462-375-07 — 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 → 53462-0375-07. 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

LabelerSage Products, LLC
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code53462
First marketedJan 2015
Product typeHuman Otc Drug
Portfolio2 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?

Corinz Cetylpyridinium Chloride is an over-the-counter oral rinse marketed as an OTC monograph product. The active ingredient, cetylpyridinium chloride, is an antimicrobial agent typically used in oral rinses to help reduce bacteria in the mouth. This rinse is swished around the mouth and is commonly used as part of daily oral hygiene routines.

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.

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.

💲 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.
Try another pack size: 7 ml 44 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

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/mLthis 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/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

🏛️
2015
On the market since
Jan 2015
📍
2026
Currently FDA-listed
11 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
53462-0375-07 You're viewing this 7 mL in 1 CUP (53462-375-07) 2019-07-22 Active
53462-0375-30 44 mL in 1 BOTTLE (53462-375-30) 2017-04-07 Active
53462-0375-60 7 mL in 1 PACKET (53462-375-60) 2015-01-20 Active

Pack size FAQ

What quantity is in NDC 53462-0375-07?
NDC 53462-0375-07 contains 7 mL — 7 ml in 1 cup.
What is the difference between NDC 53462-0375-07 and NDC 53462-0375-60?
Both are Corinz Cetylpyridinium Chloride .5 mg/mL Rinse — the drug itself is identical. NDC 53462-0375-07 is the 7 mL package, while NDC 53462-0375-60 is the 7 ml package.
What NDC number is used to bill for this package of Corinz Cetylpyridinium Chloride .5 mg/mL Rinse?
Bill NDC 53462-0375-07 — the 11-digit billing format is 53462037507. 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) — 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 FDA registers it as 53462-375-07, 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: 53462-0375-07, written without dashes as 53462037507. 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 53462-0375-07, the first segment (53462) is the labeler code FDA assigned to Sage Products, LLC; the middle segment (0375) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (07) 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 Sage Products, 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 2 other package presentations of this same product, including 7 ml (53462-0375-60), 44 ml (53462-0375-30). 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?
Sage Products, 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.
⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
⚠️ Warnings 29 words ▾

Warnings Stop use and ask a doctor if: Sore mouth symptoms do not improve in 7 days. Swelling, rash or fever develops. Irritation, pain or redness persists or worsens.

🧪 Active Ingredient 17 words ▾

Drug Facts Active ingredient: Purpose CORINZ ANTISEPTIC CLEANSING AND MOISTURIZING ORAL RINSE: Cetylpyridinium chloride 0.05% Antiseptic Rinse

🧪 Inactive Ingredients 19 words ▾

Inactive ingredients Water, glycerin, xylitol, spearmint flavor, potassium sorbate, polysorbate 20, polysorbate 80, hydroethylcellulose, citric acid, sodium saccharin, menthol

🎯 Purpose 45 words ▾

Directions Use up to 4 times daily or as directed by a dentist or doctor. Adults and children 3 years and older: rinse mouth with 1/2 Tbsp. for approx. one minute. Instruct to expectorate. Children under 3 years of age: consult a dentist or doctor.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 53462-0275-60 · Sage 53462-0705-20 · Sage →
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.