NDC 53045-0280-04 — Ionite H Sodium Fluoride, Potassium Nitrate

🆔 Identity & classification

FDA NDC (as labeled) 53045-280-04

Product NDC 53045-280

11-digit billing NDC 53045028004

RxCUI 637365

UNII 8ZYQ1474W7, RU45X2JN0Z

SPL Set ID 54c1a27c-5936-4ee2-a419-3891d3df9745

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 53045-280-04 — 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 → 53045-0280-04. 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

🔎 All NDCs from Dharma Research, Inc.

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 gel dentifrice applied to the teeth that contains sodium fluoride and potassium nitrate as active ingredients. Sodium fluoride is commonly used in dental products to help strengthen tooth enamel and reduce cavity formation. Potassium nitrate is typically included in dental formulations to help reduce tooth sensitivity. This product is marketed without an approved FDA application.

Patient education

📘 MedlinePlus patient leaflet ↗

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 system	Per g	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

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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price 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/100gthis 53045-0280-04	Dharma	122 g	—	—	FDA listed	—
Ionite H 1.1 mg/100g; 5 mg/100g 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

Serious outcomes

Hospitalization18

Death5

Life-threatening2

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
53045-0280-04 You're viewing this	122 g in 1 TUBE (53045-280-04)	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)	— 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 "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 53045-280-04, 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: 53045-0280-04, written without dashes as 53045028004. 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 53045-0280-04, the first segment (53045) is the labeler code FDA assigned to Dharma Research, Inc.; the middle segment (0280) 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 ↗

🔗 Related NDC lookups

🧪 All Sodium Fluoride, Potassium Nitrate NDCsSame ingredient 🏭 All Dharma labeler NDCsLabeler code 53045

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

🆔 Identity & classification

🏭 Manufacturer & labeler

🩺 Clinical

Patient education

Supplement & herbal interactions

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

🔬 Reported adverse events (FAERS)

Top reported reactions

Age at onset

Reporter sex

Serious outcomes

📦 Packaging — all sizes for this product

🧭 About this NDC listing & data coverage

Listed without an FDA application

Questions about this listing

📄 Full prescribing information FDA SPL

🔗 Related NDC lookups