Home › NDC Lookup › Ingredients › Sodium Fluoride › 72247-0109-12
CURODONT REPAIR FLUORIDE PLUS SODIUM .02 g/100mL Sponge, 10 cylinders — NDC 72247-0109-12 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

CURODONT REPAIR FLUORIDE PLUS SODIUM .02 g/100mL Sponge, 10 cylinders — NDC 72247-109-12 (Billing 72247-0109-12)

by CREDENTIS AG · 10 CYLINDER in 1 BOX / .1 mL in 1 CYLINDER

This is a package of 10 cylinders of CURODONT REPAIR FLUORIDE PLUS SODIUM .02 g/100mL Sponge from CREDENTIS AG, marketed since Aug 2023 and currently FDA-listed. It is this product's only package size.

NDC 72247-0109-12
🏷️ FDA NDC (as labeled) 72247-109-12 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72247-109-12
Product NDC 72247-109
11-digit billing NDC 72247010912
UNII 8ZYQ1474W7
Application # M021
SPL Set ID 03ec09f9-4281-9ccb-e063-6294a90aadd8
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-08-27
Route ORAL
Dosage form SPONGE
Substance SODIUM FLUORIDE
Why two NDCs? The FDA registers this code as 72247-109-12 — 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 → 72247-0109-12. 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.

Clinical

🧪 What is this product?

Curodont Repair Fluoride Plus is an over-the-counter oral sponge product containing sodium fluoride. Sodium fluoride is typically used in dental care products to help strengthen tooth enamel and reduce cavity formation. This product is marketed as an OTC monograph drug, meaning it follows FDA's established safety and effectiveness guidelines for its drug category rather than undergoing individual product review. The sponge format allows the fluoride solution to be applied directly to the teeth and gums.

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
72247-0109-12 You're viewing this Main listing 10 CYLINDER in 1 BOX / .1 mL in 1 CYLINDER 2023-08-27 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Curodont Repair Fluoride Plus .02 g/100mLthis 72247-0109-12 CREDENTIS 10 cylinders — — FDA listed —
Curodont Repair Fluoride Plus .02 g/100mL 72247-0108-03 CREDENTIS 2 pouches — — 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
Aug 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII MOR84MUD8E
    Chlorhexidine digluconate is an antimicrobial compound added to some medicines as a preservative to prevent bacterial and fungal growth, extending shelf life and maintaining product safety.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII MUM5TLH7X6
    A short-chain protein fragment made of amino acids linked together. It's used in formulations as a skin-conditioning agent or penetration enhancer to help the medicine's active ingredients work effectively.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 7YIN7J07X4
    A natural sugar derived from plants and microorganisms. It acts as a filler to give the medication bulk and stability, and helps preserve the active ingredient during storage and manufacturing.
  • UNII 023C2WHX2V
    Tromethamine is a chemical buffer that helps maintain the proper acidity level in liquid medicines. It neutralizes acids and stabilizes the solution so the medication remains effective and safe throughout its shelf life.
  • 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.

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

The official label also statesWATER, CHLORHEXIDINE DIGLUCONATE, TROMETHAMINE, TREHALOSE DIHYDRATE, OLIGOPEPTIDE-104, HYDROXYPROPYL METHYLCELLULOSE, CITRIC ACID, SODIUM HYDROXIDE.

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

LabelerCREDENTIS AG
FDA applicationM021 (OTC MONOGRAPH DRUG)
Labeler code72247
First marketedAug 2023
Product typeHuman Otc Drug
Portfolio3 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.

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 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 19 words ▾

USES AIDS IN THE PREVENTION OF DENTAL CAVITIES ANTICAVITY DENTAL RINSE RESTORES ENAMEL FOR THE TREATMENT OF WHITE SPOTS

⏱️ Dosage and Administration 78 words ▾

DIRECTIONS Usual dosage is one treatment per tooth. After prophylaxis treatment, remove the pellicle of the concerned tooth by using 2% sodium hypochlorite for 10 seconds. Rinse the tooth surface with water.

Remove inorganic deposits by pushing together the two cylinders and apply product with sponge on treatment area. After treatment time of five minutes have patient expectorate residues. For maximum benefits for the prevention of caries, instruct patient not to rinse, eat or drink for 30 minutes.

⚠️ Warnings 22 words ▾

WARNINGS FOR TOPICAL INTRAORAL USE ONLY. FOR PROFESSIONAL OFFICE USE ONLY. THIS PRODUCT IS NOT INTENDED FOR HOME OR UNSUPERVISED CONSUMER USE.

🧪 Active Ingredient 9 words ▾

ACTIVE INGREDIENTS SODIUM FLUORIDE 0.05% (0.02% W/V FLUORIDE ION)

🧪 Inactive Ingredients 15 words ▾

INACTIVE INGREDIENTS WATER, CHLORHEXIDINE DIGLUCONATE, TROMETHAMINE, TREHALOSE DIHYDRATE, OLIGOPEPTIDE-104, HYDROXYPROPYL METHYLCELLULOSE, CITRIC ACID, SODIUM HYDROXIDE.

🎯 Purpose 2 words ▾

PURPOSE ANTICAVITY

📄 Keep Out of Reach of Children 26 words ▾

KEEP OUT OF REACH OF CHILDREN. IF MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

📄 Other Information 22 words ▾

OTHER INFORMATION DO NOT USE IF SAFETY PACHAGING IS BROKEN OR MISSING. SINGLE USE ONLY. STORE IN A DRY AND COOL PLACE.

📄 Package Label / Principal Display Panel 1 words ▾

UC

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 CURODONT REPAIR FLUORIDE PLUS (this brand).

Top reported reactions

Pyrexia172
Weight Increased162
Nausea160
Vomiting159
Fatigue158
Pain158
Nasopharyngitis155

Age at onset

Child16
Adolescent6
Adult74
Elderly77

Reporter sex

1,067 reports
Male · 35%
Female · 65%
Unknown · 0%
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 213 43
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 ✓ 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 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 CREDENTIS AG. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
CREDENTIS AG 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.
← 72247-0108-03 · CREDENTIS 72250-0001-01 · BodyLogicMD →
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.