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Ionite H Sodium Fluoride, Potassium Nitrate 1.1 mg/100g; 5 mg/100g Gel, Dentifrice, 122 g — NDC 53045-0281-04 package photo

Ionite H Sodium Fluoride, Potassium Nitrate 1.1 mg/100g; 5 mg/100g Gel, Dentifrice, 122 g

by Dharma Research, Inc. · 122 g in 1 TUBE (53045-281-04)
NDC 53045-0281-04
🏷️ FDA NDC (as labeled) 53045-281-04 billing pads the product segment with a zero
Rx only On market Non-controlled
🗂️ Data synced Aug 27, 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) 53045-281-04
Product NDC 53045-281
11-digit billing NDC 53045028104
RxCUI 637365
UNII 8ZYQ1474W7, RU45X2JN0Z
SPL Set ID 642fec99-c5c5-4ef2-986e-5b5f7cf460de
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-08-02
Route DENTAL
Dosage form GEL, DENTIFRICE
Substance SODIUM FLUORIDE; POTASSIUM NITRATE
Why two NDCs? The FDA registers this code as 53045-281-04 — 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 → 53045-0281-04. 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

LabelerDharma Research, Inc.
Labeler code53045
First marketedAug 2015
Product typeHuman Prescription Drug
Portfolio42 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?

Ionite H is a dental gel containing sodium fluoride and potassium nitrate. Sodium fluoride is commonly used in dental products to help strengthen tooth enamel and reduce cavity formation. Potassium nitrate is typically included in formulations intended to address tooth sensitivity. This product is an unapproved drug and is marketed without 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

FlavorBubble Gum
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 H4N855PNZ1
    Alpha-tocopherol is a form of vitamin E, a fat-soluble antioxidant derived from natural or synthetic sources. In medicines, it prevents oils and fats from breaking down and becoming rancid, protecting the product's stability and shelf life.
  • UNII 4Q93RCW27E
    A synthetic polymer made from acrylic acid that's crosslinked for stability. It acts as a thickener and gelling agent in creams and gels, helping the medicine spread evenly and maintain its texture.
  • UNII 9G34HU7RV0
    EDTA is a chemical compound that binds to metals and other substances in medicines. It's used as a preservative and stabilizer to prevent discoloration and extend shelf life.
  • 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 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 P1BM4ZH95L
    A salt derived from phosphoric acid, sodium polymetaphosphate acts as a sequestrant and buffering agent in medicines. It helps maintain stability and control acidity in liquid formulations.
  • UNII K4C08XP666
    A mineral salt made from calcium and phosphate. It acts as a filler to add bulk and texture to tablets and powders, and also helps stabilize and bind ingredients together.
  • 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.
  • UNII VCQ006KQ1E
    Xylitol is a naturally occurring sugar alcohol derived from plants. It's used in medicines as a sweetener, bulking agent, and to improve taste, especially in liquid formulations and chewable tablets.

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

The official label also statesAlpha-tocopheryl, carbopol, edetic acid, flavor, glycerin, sodium hydroxide, sodium polymetaphosphate, tricalcium phosphate, water, xylitol

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 systemPer gPer 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
Sodium Fluoride 5000 ppm Sensitive 5.8 mg/mL; 57.5 mg/mL 11527-0704-42 Sheffield 1 tube $0.118 — Availability likely —
Sodium Fluoride 5000 ppm Enamel Protect 57.5 mg/mL; 5.8 mg/mL 11527-0745-34 Sheffield 1 tube $0.118 — Availability likely —
Denta 5000 Plus Sensitive 5.8 mg/mL; 57.5 mg/mL 16571-0823-10 Rising 100 ml $0.118 — Availability likely —
Sodium Fluoride and Potassium Nitrate 5.8 mg/mL; 57.5 mg/mL 69367-0318-01 Westminster 1 tube $0.118 — Availability likely —
PreviDent 5000 Enamel Protect 5.8 mg/mL; 57.5 mg/mL 00126-0022-92 Colgate 100 ml — — FDA listed —
PreviDent 5000 Sensitive 5.8 mg/mL; 57.5 mg/mL 00126-0070-61 Colgate 100 ml — — FDA listed —
Acclean Anti-Cavity Sensitivity Relief 5 g/100g; 1.1 g/100g 00404-0174-04 Henry 1 tube — — FDA listed —
Ionite H 1.1 mg/100g; 5 mg/100g 53045-0280-04 Dharma 122 g — — FDA listed —
Ionite H 1.1 mg/100g; 5 mg/100gthis 53045-0281-04 Dharma 122 g — — FDA listed —
FluoriMax 5000 Sensitive 1.1 g/100g; 5 g/100g 57511-0503-01 Elevate 96 g — — FDA listed —
Fluoridex 5 mg/g; 50 mg/g 59883-0030-04 DENT-MAT 1 tube — — FDA listed —
Fluoridex 50 mg/g; 5 mg/g 59883-0031-04 DENT-MAT 1 tube — — FDA listed —
Pro-Sys 5 g/100g; 1.1 g/100g 66975-0778-01 Benco 113 g — — FDA listed —
Pro-Sys 1.1 g/100g; 5 g/100g 66975-0779-01 Benco 113 g — — 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
Aug 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.

🔬 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 Ionite H (this brand).

Top reported reactions

Oral Discomfort5
Dyspnoea4
Nausea4
Oral Disorder4
Oral Pain4
Anaemia3
Diarrhoea3

Age at onset

Child1
Adult1
Elderly1

Reporter sex

0 reports

Serious outcomes

Hospitalization18
Death5
Life-threatening2
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 7 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
53045-0281-04 You're viewing this 122 g in 1 TUBE (53045-281-04) 2015-08-02 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 ✓ 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 "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 53045-281-04, 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: 53045-0281-04, written without dashes as 53045028104. 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 53045-0281-04, the first segment (53045) is the labeler code FDA assigned to Dharma Research, Inc.; the middle segment (0281) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 Dharma Research, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Dharma Research, 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 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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 📦 How Supplied / Storage and Handling 🧪 Inactive Ingredients 📋 Description
🎯 Indications and Usage 33 words ▾

INDICATIONS AND USAGE This is a fluoride and potassium nitrate gel intended to aid in the prevention of dental decay and to help treat tooth sensitivity to cold, heat, sweets, acids, or contact.

⏱️ Dosage and Administration 88 words ▾

DOSAGE AND ADMINISTRATION Use twice per day (morning and evening) in place of regular toothpaste or as recommended by a dentist or physician. Adults and children 12 years of age and older: Twist off cap and remove foil seal. Apply at least a 1 inch strip gel onto a soft bristle tooth brush.

Brush teeth thoroughly for at least 1 minute, spit out, and rinse mouth thoroughly. Make sure to brush all sensitive areas of the teeth. Children under 12 years of age: consult a dentist or physician.

💊 Dosage Forms and Strengths 13 words ▾

DOSAGE FORMS AND STRENGTHS Gel containing 1.1% sodium fluoride and 5% potassium nitrate.

⛔ Contraindications 25 words ▾

CONTRAINDICATIONS Avoid use in patients with known hypersensitivity to fluoride. Do not use in pediatric patients under 12 unless directed by a dentist or physician.

⚠️ Warnings and Cautions 81 words ▾

WARNINGS AND PRECAUTIONS Do not swallow. Keep out of reach of children. Read prescribing information fully before using this product.

If product is accidentially swallowed in quantities greater than would normally occur with a toothpaste, seek medical help right away. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens.

Do not use this product for longer than 4 weeks unless recommended by a dentist or physician.

🤒 Adverse Reactions 20 words ▾

ADVERSE REACTIONS To report suspected adverse reactions, contact Dharma Research, Inc. at 1-877-833-3725 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

📦 How Supplied / Storage and Handling 20 words ▾

HOW SUPPLIED/STORAGE 4.3 ounces (122 g) in a plastic tube. Store at room temperature 59 – 86°F (15 – 30°C).

🧪 Inactive Ingredients 16 words ▾

INACTIVE INGREDIENTS Alpha-tocopheryl, carbopol, edetic acid, flavor, glycerin, sodium hydroxide, sodium polymetaphosphate, tricalcium phosphate, water, xylitol

📋 Description 32 words ▾

DESCRIPTION Ionite H Neutral Fluoride Gel is a flavored, pH neutral 1.1% sodium fluoride, 5% potassium nitrate gel that aids in the prevention of dental decay and hleps to treat sensitive teeth.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 53045-0280-04 · Dharma 53045-0300-30 · Dharma →
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.