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Pro-Den Rx Sodium Fluoride 9 mg/mL Rinse, 1890 mL

by Den-Mat Holdings, Llc · 1890 mL in 1 BOTTLE, PLASTIC (59883-911-64)
NDC 59883-0911-64
🏷️ FDA NDC (as labeled) 59883-911-64 billing pads the product segment with a zero
Rx only 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

🆔 Identity & classification

FDA NDC (as labeled) 59883-911-64
Product NDC 59883-911
11-digit billing NDC 59883091164
UNII 8ZYQ1474W7
SPL Set ID ba020e07-ad41-4419-a503-f1245131b7d2
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2008-10-21
Route ORAL
Dosage form RINSE
Substance SODIUM FLUORIDE
Why two NDCs? The FDA registers this code as 59883-911-64 — 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 → 59883-0911-64. 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

LabelerDen-Mat Holdings, Llc
Labeler code59883
First marketedOct 2008
Product typeHuman Prescription Drug
Portfolio5 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?

Pro-Den Rx Sodium Fluoride 9 mg/mL Rinse is an oral rinse containing sodium fluoride, a fluorine compound typically used in dental care products. Sodium fluoride is commonly used as a topical agent to help strengthen tooth enamel and reduce cavity formation. This product is an unapproved drug and is not marketed under an FDA-approved application.

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.

💊 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 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • 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 A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 7YC686GQ8F
    A synthetic oily substance made from castor oil. It works as a solubilizer and emulsifier to help mix oily and water-based ingredients together in the medicine.
  • 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 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 SE337SVY37
    A mineral salt used as a buffer to help maintain the medicine's pH level and prevent breakdown of active ingredients. It also acts as a thickening agent in liquid formulations.
  • UNII 22ADO53M6F
    A mineral salt derived from phosphoric acid, used as a buffer to maintain the pH balance of the medication and help stabilize the active ingredients.
  • 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.

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 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Pro-Den Rx 9 mg/mLthis 59883-0911-64 Den-Mat 1890 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

🏛️
2008
On the market since
Oct 2008
📍
2026
Currently FDA-listed
18 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 Pro-Den Rx (this brand).

Top reported reactions

Pyrexia174
Nausea163
Weight Increased163
Fatigue161
Vomiting160
Pain159
Nasopharyngitis155

Age at onset

Child17
Adolescent6
Adult75
Elderly78

Reporter sex

1,109 reports
Male · 36%
Female · 64%
Unknown · 0%

Serious outcomes

Hospitalization397
Death352
Disabling79
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 198 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
59883-0911-64 You're viewing this 1890 mL in 1 BOTTLE, PLASTIC (59883-911-64) 2008-10-21 Active

🧭 About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

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 "Unapproved Drug Other". 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 59883-911-64, 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: 59883-0911-64, written without dashes as 59883091164. 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 59883-0911-64, the first segment (59883) is the labeler code FDA assigned to Den-Mat Holdings, Llc; the middle segment (0911) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (64) 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 Den-Mat Holdings, Llc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Den-Mat 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 a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🆘 Overdosage 📦 How Supplied / Storage and Handling
🎯 Indications and Usage 23 words ▾

Indications and Usage For topical application to aid in the protection against dental caries. Neutral pH is especially safe for crowns and restorations.

⏱️ Dosage and Administration 76 words ▾

Dosage and Administration Dispense ½ oz. (approx. 1 pump) of Pro-DenRx 2.0% Neutral Sodium Fluoride Solution into the provided mixing cup.

Instruct patient to rinse vigorously for 30 seconds with ½ oz. of the solution around and between teeth, then expectorate. For maximum benefit repeat the rinse procedure with an additional ½ oz. of solution. Pro-DenRx 2.0% Neutral Sodium Fluoride Solution may also be applied full strength, with cotton pledgets, to teeth isolated with cotton rolls.

⛔ Contraindications 4 words ▾

Contraindications Hypersensitivity to fluoride.

⚠️ Warnings and Cautions 45 words ▾

Warnings and Precautions For Professional Office Use Only. This product is not intended for home or unsupervised consumer use. Do not swallow. Keep out of reach of children. Not recommended for children under the age of 6. Limited to topical use in the mouth only.

🤒 Adverse Reactions 22 words ▾

Adverse Reactions The following adverse reactions are possible in individuals hypersensitive to fluoride: eczema, atopic dermatitis, urticaria, gastric distress, headache, and weakness.

🆘 Overdosage 126 words ▾

Overdosage Accidental ingestion of large amounts of fluoride can cause: nausea, vomiting, abdominal pain, diarrhea, stupor and/ or weakness (usually within 30 minutes). These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (less than 23 mg fluoride/lb body weight) has been ingested, give calcium (milk) orally to relieve symptoms and observe for a few hours.

If more than 5 mg fluoride/kg body weight (more than 23 mg fluoride/lb body weight) has been ingested, induce vomiting, give calcium (i.e., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg body weight (i.e., more than 6.9 mg fluoride/lb body weight) induce vomiting, transport and admit immediately to a hospital facility.

📦 How Supplied / Storage and Handling 69 words ▾

How Supplied/Storage and Handling 2.0% Neutral Sodium Fluoride (0.9% Fluoride Ion) oral solution supplied in a plastic bottle with child-resistant closure containing 64 fl. oz. (1.89 L). Store at room temperature.

Protect from freezing. Do not store in direct sunlight. Rx Only Revised: 12/2017 1-800-433-6628 Reorder Number: 2037MTDT Manufactured for Den-Mat Holdings, LLC 1017 W.

Central Ave. Lompoc, CA 9343611 ©2017 Den-Mat Holdings, LLC. All rights reserved.

001395000 12/17AS

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 59883-0720-08 · Den-mat 59883-0920-16 · Den-mat →
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.