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Kolorz Sixty Second Fluoride Foam Triple Mint Sodium 1.23 g/g Aerosol, Foam, 125 g — NDC 25047-0761-44 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Kolorz Sixty Second Fluoride Foam Triple Mint Sodium 1.23 g/g Aerosol, Foam, 125 g — NDC 25047-761-44 (Billing 25047-0761-44)

by DMG AMERICA, LLC · 125 g in 1 CAN

This is a package of 125 g of Kolorz Sixty Second Fluoride Foam Triple Mint Sodium 1.23 g/g Aerosol, Foam from DMG AMERICA, LLC, marketed since Nov 2006 and currently FDA-listed. It is this product's only package size.

NDC 25047-0761-44
🏷️ FDA NDC (as labeled) 25047-761-44 billing pads the product segment with a zero
Rx only On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 25047-761-44 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
25047 labeler · 761 product · 44 package
Package marketed since
Nov 22, 2006
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0043413434130, 0043415434152
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 25047-761-44
Product NDC 25047-761
11-digit billing NDC 25047076144
RxCUI 248389, 1093170
UNII 8ZYQ1474W7
UPC 0043413434130, 0043415434152
SPL Set ID 427f25e6-e50a-407a-a6f0-512123e381e4
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 AEROSOL, FOAM
Substance SODIUM FLUORIDE
Quick answers
  • RxCUI (RxNorm): 248389
Why two NDCs? The FDA registers this code as 25047-761-44 — 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 → 25047-0761-44. 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.

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?

Kolorz Sixty Second Fluoride Foam is a dental foam 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 as an unapproved drug and has not received FDA approval.

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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
25047-0761-44 You're viewing this Main listing 125 g in 1 CAN 2006-11-22 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
ZOOBY Spearmint Safari 2.72 g/100g 00273-0357-44 Young 125 g — — FDA listed —
ZOOBY Growlin Grrrape 2.72 g/100g 00273-0358-44 Young 125 g — — FDA listed —
ZOOBY Gator Gum 2.72 g/100g 00273-0370-44 Young 125 g — — FDA listed —
ZOOBY Happy Hippo Cake 2.72 g/100g 00273-0393-44 Young 125 g — — FDA listed —
ZOOBY Turtle Melon 2.72 g/100g 00273-0394-44 Young 125 g — — FDA listed —
Acclean Foam Fluoride 60 Second Application .0272 g/g 00404-1701-44 Henry 125 g — — FDA listed —
Acclean Foam Fluoride 60 Second Application .0272 g/g 00404-1711-44 Henry 125 g — — FDA listed —
Acclean Foam Fluoride 60 Second Application .0272 g/g 00404-1721-44 Henry 125 g — — FDA listed —
Acclean Foam Fluoride 60 Second Application .0272 g/g 00404-1731-44 Henry 125 g — — FDA listed —
Kolorz Sixty Second Fluoride Foam Triple Mint 1.23 g/gthis 25047-0761-44 DMG 125 g — — FDA listed —
Kolorz Sixty Second Fluoride Foam Cherry Cheesecake 1.23 g/g 25047-0762-44 DMG 125 g — — FDA listed —
Kolorz Sixty Second Fluoride Foam Cotton Candy 1.23 g/g 25047-0763-44 DMG 125 g — — FDA listed —
Kolorz Sixty Second Fluoride Foam Blue Raspberry 1.23 mg/g 25047-0764-44 DMG 125 g — — FDA listed —
Pcxx Vanilla Orange One Minute Fm .0272 g/g 62007-0051-07 Ross 125 g — — FDA listed —
Pcxx Strawberry Apf F .0272 g/g 62007-0055-07 Ross 125 g — — FDA listed —
Pcxx Peppermint Apf F .0272 g/g 62007-0059-07 Ross 125 g — — FDA listed —
Darby Apf Strawberry 2.72 g/100g 66467-8003-02 Darby 125 g — — FDA listed —
Darby Apf Mint 2.72 g/100g 66467-8004-02 Darby 125 g — — FDA listed —
Darby Apf Bubble Gum 2.72 g/100g 66467-8005-02 Darby 125 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

🏛️
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.

What it looks like

FlavorMint
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 5OCF3O11KX
    A plant-derived surfactant made from coconut oil. It helps mix oil and water ingredients together in the formulation and can improve how the medicine spreads or feels on the skin.
  • UNII KH7I04HPUU
    A salt compound made from sodium and phosphoric acid, used as a buffer to help maintain a stable pH level in the medicine, and sometimes as a binder or filler in tablets and capsules.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • 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.

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

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.

Manufacturer & labeler

LabelerDMG AMERICA, LLC
Labeler code25047
First marketedNov 2006
Product typeHuman Prescription Drug
Portfolio15 products on file

More NDCs from DMG AMERICA, LLC labeler code 25047

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.

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 ⚠️ Warnings 📋 Description 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 40 words ▾

INDICATIONS For the topical application of fluoride to aid in the protection against dental caries. Shake can thoroughly for at least 30 seconds before each use. Hold can completely upside down to dispense. See package insert for dosage information. Figure

⚠️ Warnings 27 words ▾

WARNING Avoid spraying toward open flame. Contents under pressure. Do not puncture or incinerate. Keep out of reach of children. Store between 55-80° F. Keep from freezing.

📋 Description 36 words ▾

CONTAINS Sodium Fluoride in a proprietary acidulated phosphate flavored foam base. 1.23% Fluoride Ion is available from 2.72% Sodium Fluoride. Does not contain chlorofluorocarbon propellant. Sweetened with Sucralose. Does not contain Aspartame or Saccharin. Gluten free.

📖 Instructions for Use ~1 min read ▾

kolorz ® By DMG America Instructions For Use Kolorz Sixty Second Fluoride Foam Kolorz Neutral Fluoride Foam The first time you dispense from a new bottle, gently lift upward on the nozzle to break the protective shipping tab (thin plastic tab located adjacent to "trigger"). If this tab is not broken, there could be an initial surge of foam from the dispenser. Dosage and Administration: Shake can vigorously before each use.

(Fig. 1) Turn can completely upside down to dispense. Point can towards fluoride applicator tray and slowly press the nozzle to fill tray.

Use one press per arch, as foam will expand slightly to fill the tray. (Fig. 2) Dry tooth surface and insert tray(s) in mouth.

For Kolorz Sixty Second Fluoride Foam: Have patient bite down lightly but firmly for 1 to 4 minutes; For Kolorz Neutral Fluoride Foam: Have patient bite down lightly but firmly for 4 minutes. Remove tray(s) and have patient expectorate excess Instruct patient not to eat, drink, or rinse for at least 30 minutes after application. How Supplied: Both Kolorz Sixty Second Fluoride Foam and Kolorz Neutral Fluoride Foam are available in 4.4oz.

(125g) cans and do not contain chlorofluorocarbon propellant. Caution: For professional use only. Federal U.S.A.

Law prohibits dispensing without prescription. Warning: Contents under pressure. Do not puncture or incinerate.

Store between 55-80° F. Keep from freezing. kolorz ® Distributed by DMG America 242 South Dean Street Englewood, NJ 07631 USA Tel: 201-894-5505 Fax: 201-894-0213 www.dmg-america.com 395490 Rev. 11/13 Figure Figure Figure

📄 Package Label / Principal Display Panel ~1 min read ▾

PRINCIPAL DISPLAY PANEL - 125 g Can Carton - Blue Raspberry Best Taste… Guaranteed! kolorz ® Sixty Second Fluoride Foam Blue Raspberry APF Topical Fluoride Acidulated Phosphate Fluoride 1.23% Fluoride Ion GLUTEN FREE! Contains XYLITOL CAUTION: For professional use only. Store at room temperature. Shake well before each use. NET WT.

4.4 OZ (125g) PRINCIPAL DISPLAY PANEL - 125 g Can Carton - Blue Raspberry

PRINCIPAL DISPLAY PANEL - 125 g Can Carton - Cherry Cheesecake Best Taste… Guaranteed! kolorz ® Sixty Second Fluoride Foam Cherry Cheesecake APF Topical Fluoride Acidulated Phosphate Fluoride 1.23% Fluoride Ion GLUTEN FREE! Contains XYLITOL CAUTION: For professional use only. Store at room temperature. Shake well before each use. NET WT.

4.4 OZ (125g) PRINCIPAL DISPLAY PANEL - 125 g Can Carton - Cherry Cheesecake

PRINCIPAL DISPLAY PANEL - 125 g Can Carton - Cotton Candy Best Taste… Guaranteed! kolorz ® Sixty Second Fluoride Foam Cotton Candy APF Topical Fluoride Acidulated Phosphate Fluoride 1.23% Fluoride Ion GLUTEN FREE! Contains XYLITOL CAUTION: For professional use only. Store at room temperature. Shake well before each use. NET WT.

4.4 OZ (125g) PRINCIPAL DISPLAY PANEL - 125 g Can Carton - Cotton Candy

PRINCIPAL DISPLAY PANEL - 125 g Can Carton - Triple Mint Best Taste… Guaranteed! kolorz ® Sixty Second Fluoride Foam Triple Mint APF Topical Fluoride Acidulated Phosphate Fluoride 1.23% Fluoride Ion GLUTEN FREE! Contains XYLITOL CAUTION: For professional use only. Store at room temperature. Shake well before each use. NET WT.

4.4 OZ (125g) PRINCIPAL DISPLAY PANEL - 125 g Can Carton - Triple Mint

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 FOAM TRIPLE MINT (this brand).

Top reported reactions

Pyrexia172
Weight Increased162
Nausea160
Vomiting159
Fatigue158
Pain158
Nasopharyngitis155

Reporter sex

0 reports

Serious outcomes

Death347
Life-threatening84
Disabling79
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 213 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.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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.
← 25047-0755-01 · DMG 25047-0762-44 · DMG →
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.