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Willo Minty Mist Dye Free Sodium Fluoride 1 mg/mL Paste, Dentifrice, 237 mL — NDC 84185-0302-08 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Willo Minty Mist Dye Free Sodium Fluoride 1 mg/mL Paste, Dentifrice, 237 mL — NDC 84185-302-08 (Billing 84185-0302-08)

by Willo 32, Inc. · 237 mL in 1 BOTTLE, DISPENSING

This is a package of 237 mL of Willo Minty Mist Dye Free Sodium Fluoride 1 mg/mL Paste, Dentifrice from Willo 32, Inc., marketed since Sep 2025 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 84185-0302-08
🏷️ FDA NDC (as labeled) 84185-302-08 billing pads the product segment with a zero
This package
Contains237 mL Pack sizes2 compare ↓
Main listing for product 84185-302 · Also comes in: 2 bottles 84185-302-22
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 13, 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 84185-302-08
Product NDC 84185-302
11-digit billing NDC 84185030208
UNII 8ZYQ1474W7
UPC 0850036633808, 0850036633129
Application # M021
SPL Set ID 3ee5b49e-ca9a-ece6-e063-6394a90a3d00
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-09-16
Route DENTAL
Dosage form PASTE, DENTIFRICE
Substance SODIUM FLUORIDE
Why two NDCs? The FDA registers this code as 84185-302-08 — 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 → 84185-0302-08. 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.

Clinical

🧪 What is this product?

Willo Minty Mist Dye Free is a toothpaste product containing sodium fluoride, an over-the-counter monograph drug marketed under FDA guidelines for oral care products. Sodium fluoride is commonly used in dentifrices to help strengthen tooth enamel and reduce cavity formation. This fluoride toothpaste is applied topically to the teeth during brushing as part of routine oral hygiene.

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.
Try another pack size: 2 bottles
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
84185-0302-08 You're viewing this Main listing 237 mL in 1 BOTTLE, DISPENSING 2025-09-16 — Active
84185-0302-22 84185-302-22 2 BOTTLE, PUMP in 1 BOX / 59 mL in 1 BOTTLE, PUMP 2025-09-16 — Active

Pack size FAQ

What quantity is in this package?
This package contains 237 mL — 237 ml in 1 bottle, dispensing.
What NDC number is used to bill for this package of Willo Minty Mist Dye Free Sodium Fluoride 1 mg/mL Paste, Dentifrice?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Willo Bubble Twist 1 mg/mL 84185-0102-08 Willo 237 ml — — FDA listed —
Willo Minty Mist Dye Free 1 mg/mLthis 84185-0302-08 Willo 237 ml — — FDA listed —
Willo Berry Splash Dye Free 1 mg/mL 84185-0202-08 Willo 237 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

🏛️
2025
On the market since
Sep 2025
📍
2026
Currently FDA-listed
1 year 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 MLM29U2X85
    Calcium citrate is a salt derived from citric acid and calcium. It acts as a buffer to stabilize the medicine's pH, a filler to add bulk, and sometimes a source of calcium in the formulation.
  • 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 PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII L7T10EIP3A
    A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
  • UNII 2AS3MDK9CB
    A liquid polymer derived from petroleum that mixes well with water and oils. It acts as a solvent, humectant, and thickening agent in medicines to help dissolve active ingredients and improve texture and stability.
  • UNII 836SJG51DR
    Sodium ascorbyl phosphate is a derivative of vitamin C that acts as an antioxidant and preservative in medications. It helps protect the drug's active ingredients from degradation caused by air and light exposure.
  • 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 8MDF5V39QO
    A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.
  • UNII BMT4RCZ3HG
    Sodium cocoyl glutamate is a mild cleanser derived from coconut oil and amino acids. It's used in medicines as a surfactant to help dissolve and distribute active ingredients evenly throughout the formulation.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII 0YON5MXJ9P
    A natural sweetener extracted from stevia plant leaves. It's used in medicines to improve taste without adding calories, making bitter drugs easier to take.
  • 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 44FQ49X6UN
    A polysaccharide (complex carbohydrate) derived from yeast cell walls. In medicines, it acts as a binder to hold tablet ingredients together and may help with tablet structure and stability.

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

The official label also statesInactive ingredients Water, Sorbitol, Sodium Cocoyl Glutamate, Glycerin, PEG-400, Sucralose, Flavor, Citric Acid, Beta-Glucan, Sodium Bicarbonate, Sodium Benzoate, Sodium Ascorbyl Phosphate, Stevioside, Menthol, Calcium Citrate

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.

Manufacturer & labeler

LabelerWillo 32, Inc.
FDA applicationM021 (OTC MONOGRAPH DRUG)
Labeler code84185
First marketedSep 2025
Product typeHuman Otc Drug
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.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 9 words ▾

Use Use Aids in the prevention of dental cavities

⏱️ Dosage and Administration 67 words ▾

Directions Directions adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor children under 6 years of age instruct in good brushing habits (to minimize swallowing). Supervise as necessary until capable or using without supervision children under 2 years of age consult with a dentist or doctor

⚠️ Warnings 42 words ▾

Warnings Warnings Keep out of reach of children Keep out of reach of children under 6 years of age, without adult supervision. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 11 words ▾

Drug Facts Active ingredient Sodium fluoride 0.22% (0.10% w/v fluoride ion)

🧪 Inactive Ingredients 27 words ▾

Inactive ingredients Inactive ingredients Water, Sorbitol, Sodium Cocoyl Glutamate, Glycerin, PEG-400, Sucralose, Flavor, Citric Acid, Beta-Glucan, Sodium Bicarbonate, Sodium Benzoate, Sodium Ascorbyl Phosphate, Stevioside, Menthol, Calcium Citrate

🎯 Purpose 3 words ▾

Purpose Purpose Anticavity

📄 Keep Out of Reach of Children 40 words ▾

Keep out of reach of children Keep out of reach of children under 6 years of age, without adult supervision. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

📄 Other Information 14 words ▾

Broken seal warning Do not use if seal under cap is broken or missing

📄 Questions or Comments 15 words ▾

Questions or comments Questions or comments? Tel: 1(888)509-0459 - Email: [email protected] Visit us at www.willo.com

📄 Package Label / Principal Display Panel 58 words ▾

Willo Minty Mist Anticavity Fluoride Liquid Toothpaste Helps Prevent Cavities & Strengthens Enamel 8 fl oz (237 ml) Scan code to buy another bottle Dist. by: Willo 32, Ince New York, NY 10006 1 (888) 509-0459 Willo Minty Mist Dye Free Fluoride 8oz Willo Minty Mist Dye Free Fluoride Box Willo Minty Mist Dye Free Fluoride Label 2oz

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 Willo Minty Mist Dye Free (this brand).

Top reported reactions

Pyrexia172
Weight Increased162
Nausea160
Vomiting159
Fatigue158
Pain158
Nasopharyngitis155

Age at onset

Child16
Adolescent6
Adult74
Elderly77

Reporter sex

1,067 reports
Male · 35%
Female · 65%
Unknown · 0%

Serious outcomes

Hospitalization379
Death347
Life-threatening84
Disabling79
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 213 34
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

Over-the-counter (OTC) product
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 "Otc Monograph Drug". 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 Willo 32, 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 2 bottles (84185-0302-22). 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?
Willo 32, 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 an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
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.
← 84185-0202-08 · Willo 84190-0001-02 · RK →
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.