Ionite APF Sodium Fluoride 10.241 g/490g Gel, 245 g
by Dharma Research, inc. · 245 g in 1 BOTTLE (53045-200-08)
NDC 53045-0200-08
🏷️ FDA NDC (as labeled)
53045-200-08
billing pads the product segment with a zero
This package
Contains245 g
Pack sizes2 compare ↓
Also comes in:
490 g 53045-0200-17
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 →
🆔 Identity & classification
FDA NDC (as labeled)
53045-200-08
Product NDC
53045-200
11-digit billing NDC
53045020008
RxCUI
245593
UNII
8ZYQ1474W7
UPC
0353045000222
SPL Set ID
503ca71a-f50c-4406-b925-5b6ac36a9212
DEA schedule
Non-controlled
Marketing category
UNAPPROVED DRUG OTHER
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2013-01-01
Route
DENTAL, ORAL
Dosage form
GEL
Substance
SODIUM FLUORIDE
Why two NDCs?
The FDA registers this code as 53045-200-08 — 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 → 53045-0200-08. 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 Caries prophylactic agents class.
Drug family (ATC)
Caries prophylactic agents, Fluoride
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
LabelerDharma Research, inc.
Labeler code53045
First marketedJan 2013
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
📖 About the active ingredient: Sodium Fluoride MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.
Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usually is prescribed for children and adults whose homes have water that is not fluoridated (already has fluoride added). This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Read the full MedlinePlus article ↗🧪 What is this product?
Ionite APF is a prescription dental gel containing sodium fluoride. Sodium fluoride is commonly used in dental products to help strengthen tooth enamel and reduce cavity formation. This gel is applied topically in the mouth by dental professionals during in-office treatments. This product is marketed without an approved FDA application.
Patient education
Supplement & herbal interactions
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.
💬 Questions about Sodium Fluoride?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 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 WR1WPI7EW8
A synthetic form of vitamin E used as an antioxidant. It prevents oils and fats in the medicine from breaking down and becoming rancid, helping keep the product stable during storage.
-
UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
-
UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
-
UNII 6M3P64V0NC
A fine powder made from magnesium, aluminum, and silicon compounds. It absorbs moisture and helps keep medicine ingredients from clumping or separating, so the product stays stable and flows smoothly during manufacturing.
-
UNII E4GA8884NN
Phosphoric acid is a weak mineral acid used in medicines as a buffer and pH adjuster. It helps stabilize the product and control its acidity level.
-
UNII 7T1F30V5YH
A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
-
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 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
-
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 TTV12P4NEE
Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
-
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.
12 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesCitric Acid, FD & C Red No. 40 (C.I. 16035), Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Purified Water, Sodium Benzoate, Sodium Saccharin, Sweetness Enhancer, Titanium Dioxide, Tocopheryl Acetate, Xanthan Gum, 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 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.
Try another pack size:
490 g
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 |
|---|---|---|---|---|---|---|
| Zap APF 5.6 g/454g 24794-0100-16 | Crosstex | 454 g | — | — | FDA listed | — |
| Zap APF 5.6 g/454g 24794-0101-16 | Crosstex | 454 g | — | — | FDA listed | — |
| Zap APF 5.6 g/454g 24794-0102-16 | Crosstex | 454 g | — | — | FDA listed | — |
| Zap APF 5.6 g/454g 24794-0103-16 | Crosstex | 454 g | — | — | FDA listed | — |
| Zap APF 5.6 g/454g 24794-0104-16 | Crosstex | 454 g | — | — | FDA listed | — |
| Zap APF 5.6 g/454g 24794-0105-16 | Crosstex | 454 g | — | — | FDA listed | — |
| Zap APF 5.6 g/454g 24794-0106-16 | Crosstex | 454 g | — | — | FDA listed | — |
| Zap APF 5.6 g/454g 24794-0107-16 | Crosstex | 454 g | — | — | FDA listed | — |
| Zap Neutral 4.086 g/454g 24794-0108-16 | Crosstex | 454 g | — | — | FDA listed | — |
| Zap APF 5.6 g/454g 24794-0109-16 | Crosstex | 454 g | — | — | FDA listed | — |
| Burkhart Neutral pH 4.086 g/454g 43498-0150-15 | Burkhart | 454 g | — | — | FDA listed | — |
| Burkhart Neutral pH 4.086 g/454g 43498-0151-15 | Burkhart | 454 g | — | — | FDA listed | — |
| Ionite APF 10.241 g/490gthis 53045-0200-08 | Dharma | 245 g | — | — | FDA listed | — |
| Ionite APF 10.241 g/490g 53045-0201-08 | Dharma | 245 g | — | — | FDA listed | — |
| Pcxx Vanilla Orange Neutral Gl 20 mg/mL 62007-0823-16 | Ross | 473 ml | — | — | FDA listed | — |
| Pcxx Peppermint Neutral Gl 20 mg/mL 62007-0825-16 | Ross | 473 ml | — | — | FDA listed | — |
| Pcxx Raspberry Neutral Gl 20 mg/mL 62007-0826-16 | Ross | 473 ml | — | — | FDA listed | — |
| Pcxx Watermelon Neutral Gl 20 mg/mL 62007-0827-16 | Ross | 473 ml | — | — | FDA listed | — |
| 60 Second Fluoride Gel 5.6 g/454g 66467-2210-01 | Darby | 454 g | — | — | FDA listed | — |
| 60 Second Fluoride Gel 5.6 g/454g 66467-2220-01 | Darby | 454 g | — | — | FDA listed | — |
| 60 Second Fluoride Gel 5.6 g/454g 66467-2230-01 | Darby | 454 g | — | — | FDA listed | — |
| 60 Second Fluoride Gel 5.6 g/454g 66467-2240-01 | Darby | 454 g | — | — | FDA listed | — |
| 60 Second Fluoride Gel 5.6 g/454g 66467-2250-01 | Darby | 454 g | — | — | FDA listed | — |
| 60 Second Fluoride Gel 5.6 g/454g 66467-2260-01 | Darby | 454 g | — | — | FDA listed | — |
| 60 Second Fluoride Gel 5.6 g/454g 66467-2270-01 | Darby | 454 g | — | — | FDA listed | — |
| Iris 60 Second APF 5.6 g/454g 66975-0050-15 | Benco | 454 g | — | — | FDA listed | — |
| Iris 60 Second APF 5.6 g/454g 66975-0051-15 | Benco | 454 g | — | — | FDA listed | — |
| Iris 60 Second APF 5.6 g/454g 66975-0052-15 | Benco | 454 g | — | — | FDA listed | — |
| Iris 60 Second APF 5.6 g/454g 66975-0053-15 | Benco | 454 g | — | — | FDA listed | — |
| Iris 60 Second APF 5.6 g/454g 66975-0054-15 | Benco | 454 g | — | — | FDA listed | — |
| Gelato APF 5.6 g/454g 68400-0105-15 | Mycone | 454 g | — | — | FDA listed | — |
| Gelato APF 5.6 g/454g 68400-0106-15 | Mycone | 454 g | — | — | FDA listed | — |
| Gelato APF 5.6 g/454g 68400-0107-15 | Mycone | 454 g | — | — | FDA listed | — |
| Gelato APF 5.6 g/454g 68400-0108-15 | Mycone | 454 g | — | — | FDA listed | — |
| Gelato APF 5.6 g/454g 68400-0109-15 | Mycone | 454 g | — | — | FDA listed | — |
| Gelato APF 5.6 g/454g 68400-0110-15 | Mycone | 454 g | — | — | FDA listed | — |
| Gelato APF 5.6 g/454g 68400-0111-15 | Mycone | 454 g | — | — | FDA listed | — |
| Gelato Neutral pH 4.086 g/454g 68400-0114-15 | Mycone | 454 g | — | — | FDA listed | — |
| Gelato Neutral pH 4.086 g/454g 68400-0115-15 | Mycone | 454 g | — | — | FDA listed | — |
| Gelato APF 5.6 g/454g 68400-0120-15 | Mycone | 454 g | — | — | FDA listed | — |
| Gelato APF 5.6 g/454g 68400-0121-15 | Mycone | 454 g | — | — | FDA listed | — |
| Gelato APF 5.6 g/454g 68400-0122-15 | Mycone | 454 g | — | — | FDA listed | — |
| Gelato APF 5.6 g/454g 68400-0135-15 | Mycone | 454 g | — | — | FDA listed | — |
| Gelato Neutral pH 4.086 g/454g 68400-0136-15 | Mycone | 454 g | — | — | FDA listed | — |
| Gelato APF 5.6 g/454g 68400-0313-15 | Mycone | 454 g | — | — | FDA listed | — |
| Gelato Neutral pH 4.086 g/454g 68400-0324-15 | Mycone | 454 g | — | — | FDA listed | — |
| PureLife APF 5.6 g/454g 68987-0010-15 | PureLife | 454 g | — | — | FDA listed | — |
| PureLife APF 5.6 g/454g 68987-0011-15 | PureLife | 454 g | — | — | FDA listed | — |
| PureLife APF 5.6 g/454g 68987-0012-15 | PureLife | 454 g | — | — | FDA listed | — |
| PureLife APF 5.6 g/454g 68987-0013-15 | PureLife | 454 g | — | — | FDA listed | — |
| PureLife APF 5.6 g/454g 68987-0014-15 | PureLife | 454 g | — | — | FDA listed | — |
| Top Quality Mfg APF 5.6 g/454g 69301-0025-15 | Top | 454 g | — | — | Discontinued | — |
| Top Quality Mfg APF 5.6 g/454g 69301-0026-15 | Top | 454 g | — | — | Discontinued | — |
| Top Quality Mfg APF 5.6 g/454g 69301-0027-15 | Top | 454 g | — | — | Discontinued | — |
| Top Quality Mfg APF 5.6 g/454g 69301-0028-15 | Top | 454 g | — | — | Discontinued | — |
| Top Quality Mfg APF 5.6 g/454g 69301-0029-15 | Top | 454 g | — | — | Discontinued | — |
| Top Quality Mfg APF 5.6 g/454g 69301-0030-15 | Top | 454 g | — | — | Discontinued | — |
| Top Quality Mfg APF 5.6 g/454g 69301-0031-15 | Top | 454 g | — | — | Discontinued | — |
| Top Quality Mfg APF 5.6 g/454g 69301-0032-15 | Top | 454 g | — | — | Discontinued | — |
| Top Quality Mfg APF 5.6 g/454g 69301-0033-15 | Top | 454 g | — | — | Discontinued | — |
| Top Quality Mfg APF 5.6 g/454g 69301-0034-15 | Top | 454 g | — | — | Discontinued | — |
| Tiger Supply Inc APF 5.6 g/454g 69484-0050-15 | Tiger | 454 g | — | — | FDA listed | — |
| Tiger Supply Inc APF 5.6 g/454g 69484-0051-15 | Tiger | 454 g | — | — | FDA listed | — |
| Tiger Supply Inc APF 5.6 g/454g 69484-0052-15 | Tiger | 454 g | — | — | FDA listed | — |
| Tiger Supply Inc APF 5.6 g/454g 69484-0053-15 | Tiger | 454 g | — | — | FDA listed | — |
| Tiger Supply Inc APF 5.6 g/454g 69484-0054-15 | Tiger | 454 g | — | — | FDA listed | — |
| Tiger Supply Inc APF 5.6 g/454g 69484-0055-15 | Tiger | 454 g | — | — | FDA listed | — |
| Tiger Supply Inc APF 5.6 g/454g 69484-0056-15 | Tiger | 454 g | — | — | FDA listed | — |
| Tiger Supply Inc APF 5.6 g/454g 69484-0057-15 | Tiger | 454 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
🏛️
2013
On the market since
Jan 2013
📍
2026
Currently FDA-listed
13 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 APF (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 35%
Female · 65%
Unknown · 0%
Serious outcomes
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 |
|---|---|---|---|
| 53045-0200-08 You're viewing this | 245 g in 1 BOTTLE (53045-200-08) | 2013-01-01 | Active |
| 53045-0200-17 | 490 g in 1 BOTTLE (53045-200-17) | 2013-01-01 | Active |
You're viewing the smallest of 2 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 53045-0200-08?
NDC 53045-0200-08 contains 245 g — 245 g in 1 bottle.
What is the difference between NDC 53045-0200-08 and NDC 53045-0200-17?
Both are Ionite APF Sodium Fluoride 10.241 g/490g Gel — the drug itself is identical. NDC 53045-0200-08 is the 245 g package, while NDC 53045-0200-17 is the 490 g package.
What NDC number is used to bill for this package of Ionite APF Sodium Fluoride 10.241 g/490g Gel?
Bill NDC 53045-0200-08 — the 11-digit billing format is 53045020008. 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
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 53045-200-08, 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: 53045-0200-08, written without dashes as 53045020008. 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 53045-0200-08, the first segment (53045) is the labeler code FDA assigned to Dharma Research, inc.; the middle segment (0200) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (08) 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.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 490 g (53045-0200-17). 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?
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.
⚠️ Warnings and Cautions ▾
Keep out of the reach of children. Do not swallow. If product is accidentally swallowed in quantities greater than would normally occur with a treatment gel, seek medical help or contact a Poison Control Center right away. Do not use on patients with an allergy Fluoride. Ionite APF Gel contains artificial color, confirm that no kno.wn patient allergies exist. For professional use only.
📦 Storage and Handling ▾
Store at 59 o - 86 o F (15 o - 30 o C) Protect from freezing Ionite APF Gel is free of gluten, soymilk, egg peanut and free of nut products
🧪 Inactive Ingredients ▾
Citric Acid, FD & C Red No. 40 (C.I. 16035), Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Purified Water, Sodium Benzoate, Sodium Saccharin, Sweetness Enhancer, Titanium Dioxide, Tocopheryl Acetate, Xanthan Gum, Xylitol
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.