KOLORZ SIXTY SECOND FLUORIDE TRIPLE MINT SODIUM 12.3 mg/mL Gel, 480 mL
by DMG AMERICA, LLC · 480 mL in 1 BOTTLE (25047-771-16)
NDC 25047-0771-16
🏷️ FDA NDC (as labeled)
25047-771-16
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 →
🆔 Identity & classification
FDA NDC (as labeled)
25047-771-16
Product NDC
25047-771
11-digit billing NDC
25047077116
UNII
8ZYQ1474W7
SPL Set ID
21fa26f2-0162-4044-aec0-d5360be3f3e0
DEA schedule
Non-controlled
Marketing category
UNAPPROVED DRUG OTHER
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2006-11-22
Route
DENTAL
Dosage form
GEL
Substance
SODIUM FLUORIDE
Why two NDCs?
The FDA registers this code as 25047-771-16 — 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 → 25047-0771-16. 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
LabelerDMG AMERICA, LLC
Labeler code25047
First marketedNov 2006
Product typeHuman Prescription Drug
Portfolio15 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?
Kolorz Sixty Second Fluoride Triple Mint is a dental gel containing sodium fluoride that is applied directly to the teeth. Sodium fluoride is commonly used in dental products to help strengthen tooth enamel and reduce cavity formation. 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.
🧪 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 |
|---|---|---|---|---|---|---|
| Kolorz Sixty Second Fluoride Triple Mint 12.3 mg/mLthis 25047-0771-16 | DMG | 480 ml | — | — | FDA listed | — |
| Kolorz Sixty Second Fluoride Cherry Cheesecake 12.3 mg/mL 25047-0772-16 | DMG | 480 ml | — | — | FDA listed | — |
| Kolorz Sixty Second Fluoride Cotton Candy 12.3 mg/mL 25047-0773-16 | DMG | 480 ml | — | — | FDA listed | — |
| Kolorz Sixty Second Fluoride Blue Raspberry 12.3 mg/mL 25047-0774-16 | DMG | 480 ml | — | — | FDA listed | — |
| Kolorz Sixty Second Fluoride Pina Colada 12.3 mg/mL 25047-0775-16 | DMG | 480 ml | — | — | FDA listed | — |
| Ionite APF 6.027 g/490g 53045-0202-17 | Dharma | 490 g | — | — | FDA listed | — |
| Ionite APF 6.027 g/490g 53045-0203-17 | Dharma | 490 g | — | — | FDA listed | — |
| Ionite APF 6.027 g/490g 53045-0204-17 | Dharma | 490 g | — | — | FDA listed | — |
| Ionite APF 6.027 g/490g 53045-0205-17 | Dharma | 490 g | — | — | FDA listed | — |
| Ionite APF 6.027 g/490g 53045-0206-08 | Dharma | 245 g | — | — | FDA listed | — |
| Ionite APF 6.027 g/490g 53045-0207-17 | Dharma | 490 g | — | — | FDA listed | — |
| Pcxx Bubblegum Apf G 27.2 mg/mL 62007-0802-16 | Ross | 473 ml | — | — | FDA listed | — |
| Pcxx Marshmallow Apf G 27.2 mg/mL 62007-0805-16 | Ross | 473 ml | — | — | FDA listed | — |
| Pcxx Creme De Menthe Apf G 27.2 mg/mL 62007-0806-16 | Ross | 473 ml | — | — | FDA listed | — |
| Pcxx Grape Apf G 27.2 mg/mL 62007-0812-16 | Ross | 473 ml | — | — | FDA listed | — |
| Pcxx Watermelon Apf G 27.2 mg/mL 62007-0813-16 | Ross | 473 ml | — | — | FDA listed | — |
| Pcxx Cool Peppermint Apf G 27.2 mg/mL 62007-0814-16 | Ross | 473 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
🏛️
2006
On the market since
Nov 2006
📍
2026
Currently FDA-listed
20 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 KOLORZ SIXTY SECOND FLUORIDE TRIPLE MINT (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 |
|---|---|---|---|
| 25047-0771-16 You're viewing this | 480 mL in 1 BOTTLE (25047-771-16) | 2006-11-22 | 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 25047-771-16, 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: 25047-0771-16, written without dashes as 25047077116. 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 25047-0771-16, the first segment (25047) is the labeler code FDA assigned to DMG AMERICA, LLC; the middle segment (0771) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (16) 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 DMG AMERICA, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
DMG AMERICA, 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
⚠️ Warnings
📦 Storage and Handling
📋 Description
🎯 Indications and Usage ▾
INDICATIONS For topical application of fluoride to aid in the protection against dental caries.
⏱️ Dosage and Administration ▾
DOSAGE & ADMINISTRATION Fill fluoride tray(s) 1/3 full with gel. Dry tooth surface and insert tray(s) in mouth. Have patient bite down for 60 seconds (or up to 4 minutes). Slight chewing motion provides interproximal coverage. Remove tray(s) and have patient expectorate excess gel. Advise patient not to eat, drink or rinse for 30 minutes.
⚠️ Warnings ▾
WARNING Keep out of reach of children. Do not swallow. If dosage or less than 100mg is ingested, contact poison control.
📦 Storage and Handling ▾
Store between 68-77° F. Keep from freezing.
📋 Description ▾
CONTAINS Sodium Fluoride in a proprietary acidulated phosphate flavored gel base. 1.23% Fluoride Ion from 2.72% Sodium Fluoride. Sweetened with Sucralose. Does not contain Aspartame or Saccharin. Gluten Free.
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.