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Gelato Neutral pH Sodium Fluoride 4.086 g/454g Gel, 454 g

by Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. · 454 g in 1 BOTTLE, PLASTIC (68400-114-15)
NDC 68400-0114-15
🏷️ FDA NDC (as labeled) 68400-114-15 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) 68400-114-15
Product NDC 68400-114
11-digit billing NDC 68400011415
RxCUI 245593, 656838
UNII 8ZYQ1474W7
SPL Set ID 281fe774-91e1-403f-b58a-92bcc09292ab
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-03-01
Route DENTAL
Dosage form GEL
Substance SODIUM FLUORIDE
Why two NDCs? The FDA registers this code as 68400-114-15 — 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 → 68400-0114-15. 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

LabelerMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.
Labeler code68400
First marketedMar 2013
Product typeHuman Prescription Drug
Portfolio23 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?

Gelato Neutral pH is a dental gel containing sodium fluoride, marketed without an FDA-approved application. Sodium fluoride is commonly used in dental products to help strengthen tooth enamel and reduce the risk of tooth decay. This gel formulation is applied topically to the teeth and is intended for professional dental use.

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 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
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/490g 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/454gthis 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
Mar 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
68400-0114-15 You're viewing this 454 g in 1 BOTTLE, PLASTIC (68400-114-15) 2018-04-01 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) — 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 68400-114-15, 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: 68400-0114-15, written without dashes as 68400011415. 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 68400-0114-15, the first segment (68400) is the labeler code FDA assigned to Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.; the middle segment (0114) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (15) 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 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products 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 ⚠️ Warnings 📦 Storage and Handling 🧪 Inactive Ingredients
🎯 Indications and Usage 31 words ▾

Indications and Usage: A stable thixotropic fluoride treatment gel used to help prevent dental decay. For Professional Office Use Only. This product is not intended for home or unsupervised consumer use.

⏱️ Dosage and Administration 88 words ▾

Dosage and Administration: Shake well before use. This is a four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment twice a year.

1. After thorough prophylaxis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth.

2. Instruct patient to bite down lightly but firmly for four minutes. 3.

Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.

⚠️ Warnings 42 words ▾

Warnings: Keep out of 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 Conrol Center right away. Read directions carefully before using.

📦 Storage and Handling 11 words ▾

Other Information: • Do not store above 25°C/77°F. Do not freeze.

🧪 Inactive Ingredients 42 words ▾

Inactive Ingredients: Citric Acid, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Potassium Hydroxide, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol. May contain blue #1, green#3, red #3, red #40, yellow #5 (tartrazine), yellow #6 as a color additive.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 68400-0111-15 · Mycone 68400-0115-15 · Mycone →
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.