Home › NDC Lookup › Ingredients › Sodium Fluoride › 68599-9573-01
Fluoride .22 g/g Paste, 24.1 g — NDC 68599-9573-01 package photo

Fluoride .22 g/g Paste, 24.1 g

by McKesson · 24.1 g in 1 TUBE (68599-9573-1)
NDC 68599-9573-01
🏷️ FDA NDC (as labeled) 68599-9573-1 billing pads the package segment with a zero
This package
Contains24.1 g Pack sizes4 compare ↓
Also comes in: 42.5 g 68599-9573-02 78 g 68599-9573-03 113.4 g 68599-9573-04
OTC 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) 68599-9573-1
Product NDC 68599-9573
11-digit billing NDC 68599957301
RxCUI 245598
UNII 8ZYQ1474W7
UPC 0612479281479, 0612479281431
Application # M021
SPL Set ID 5025e58e-e59c-07b6-e063-6394a90ac1e8
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-04-23
Route DENTAL
Dosage form PASTE
Substance SODIUM FLUORIDE
Why two NDCs? The FDA registers this code as 68599-9573-1 — a 5-4-1 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 package segment → 68599-9573-01. 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

LabelerMcKesson
FDA applicationM021 (OTC MONOGRAPH DRUG)
Labeler code68599
First marketedApr 2026
Product typeHuman Otc Drug
Portfolio27 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 it is MedlinePlus · NLM

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 ↗
📗 Our plain-language guide HelloPharmacist
  • Fluoride toothpaste works to protect your teeth from cavities. When you brush with it regularly, it helps shield your teeth from the acids that break down enamel (the hard outer la...
  • What is fluoride toothpaste actually doing for my teeth?
  • Both 365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity and Equate Anticavity Oral Rinse are meant to be used twice a day, after you've already brushed your te...
  • How often should I use a fluoride mouth rinse?
📖 Read our full Fluoride guide →

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 5C69YCD2YJ
    Carrageenan is a natural thickener and stabilizer extracted from red seaweed. It's used in medicines to create gel-like textures, improve consistency, and help keep ingredients from separating during storage.
  • UNII K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • 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 1212Z7S33A
    PEG-32 is a synthetic polymer derived from ethylene oxide. It acts as a humectant and solvent in medications, helping to dissolve or suspend active ingredients and maintain moisture in solid dosage forms.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • 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 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • 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 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 O352864B8Z
    A sodium salt compound used in medicines as a buffering agent to maintain pH stability and as a chelating agent to prevent unwanted chemical reactions during storage and mixing.
  • 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 AR7OGW33N1
    A salt made from sodium and phosphoric acid. It works as a buffer to help stabilize the medicine's pH and may also serve as a binding or thickening agent in tablets and liquids.
  • 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.

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

The official label also statesInactive ingredients Sorbitol, Silica, Treated Water, Glycerin, PEG-32, Sodium Lauryl Sulfate, Flavor, Titanium Dioxide, Cellulose Gum, Carrageenan, Trisodium Phosphate, Sodium Saccharin, Sodium Benzoate, Tetrasodium Pyrophosphate, FD&C Blue # 1.

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 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: 42.5 g 78 g 113.4 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Charm Tex FLUORIDE Gel .1 g/100g 42086-0052-01 Jiangsu 1000 tubes — — FDA listed —
botalab HERBAL COMPLETE TOOTH .22 g/100g 50555-0201-02 KMPHARMACEUTICAL 1 tube — — FDA listed —
Freshmint Anticavity Fluoride 2.2 mg/g 51824-0068-01 New 7.9 g — — FDA listed —
Maximum Security 2.2 mg/g 53247-0130-01 Bob 4.3 g — — FDA listed —
CinnaFresh 2.2 mg/g 53247-0134-01 Bob 24 g — — FDA listed —
Maximum Security 2.2 mg/g 53247-0143-01 Bob 4.3 g — — Discontinued —
Sodium fluoride .22 g/100g 65517-2000-00 DUKAL 17 g — — Discontinued —
DawnMist Gel Fluoride .22 g/100g 65517-2004-00 Dukal 78 g — — FDA listed —
DawnMist .22 g/100g 65517-2005-00 Dukal 17 g — — FDA listed —
Dawnmist Fluoride .22 g/100g 65517-2017-00 Dukal 78 g — — Discontinued —
Sodium Fluoride 220 mg/g 67777-0180-03 Dynarex 144 tubes — — FDA listed —
Bubble Fresh Toothpaste, with Fluoride 220 mg/g 67777-0191-03 Dynarex 144 tubes — — FDA listed —
Fluoride .22 g/gthis 68599-9573-01 McKesson 24.1 g — — FDA listed —
Botao Kids Strawberry Flavored with Fluoride .122 g/100mL 69435-1405-01 Peer 1 tube — — FDA listed —
Gerigentle-Good morning .22 g/100g 69771-0091-38 Geri-Gentle 43 g — — FDA listed —
Charm Tex FLUORIDE Gel .1 g/100g 71035-0002-01 Yangzhou 1000 tubes — — FDA listed —
ZONSEN Gel Fluoride .22 g/100g 72932-0015-00 Wuhan 17 g — — FDA listed —
ZONSEN Toothpaste,white .22 g/100g 72932-0016-00 Wuhan 17 g — — FDA listed —
DOCTRUST DOUBLEX Tooth .22 g/100g 73242-1122-02 DONG 1 tube — — FDA listed —
DOCTRUST DOUBLEX Tooth .22 g/100g 76670-0010-02 DOCSMEDI 1 tube — — FDA listed —
Dr. Jen SuperPaste Nano-Hydroxyapatite .22 g/100mL 84181-0357-05 Dr 1 tube — — FDA listed —
Dr. Jen SuperPaste Perio .22 g/100mL 84181-0358-08 Dr 1 tube — — FDA listed —
Dr. Jen SuperPaste Ortho .22 g/100mL 84181-0359-09 Dr 1 tube — — FDA listed —
Dr. Jen SuperPaste Nano-Hydroxyapatite .22 g/100mL 84181-0735-07 Dr 1 tube — — FDA listed —
Willo Bubble Twist 1 mg/mL 84185-0102-08 Willo 237 ml — — FDA listed —
Willo Berry Splash Dye Free 1 mg/mL 84185-0202-08 Willo 237 ml — — FDA listed —
AMERFRESH FLUORIDE gel .1 g/100g 85162-0001-01 Yangzhou 144 tubes — — FDA listed —
Amerfresh Fluoride .1 g/100g 85162-0002-01 Yangzhou 144 tubes — — FDA listed —
AdoptaPlatoon .1 g/100mL 85162-0004-01 Yangzhou 10 ml — — FDA listed —
Amerfresh Toothpowder .1 g/100g 85162-0007-01 Yangzhou 454 g — — FDA listed —
Maximum Security Anticavity Gel fresh mint flavor .1 g/100g 85891-0008-01 SPARROW 4.25 g — — Discontinued —
Osstem G Gum Health Care Tooth .22 g/100g 87548-0020-02 Osstem 1 tube — — 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

🏛️
2026
On the market since
Apr 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Fluoride — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Fluoride. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$456.95
Claims incl. refills
77
Beneficiaries
45
Spend / beneficiary
$10.15
Spend / claim
$5.93
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
68599-9573-01 You're viewing this 24.1 g in 1 TUBE (68599-9573-1) 2026-04-23 Active
68599-9573-02 42.5 g in 1 TUBE (68599-9573-2) 2026-04-23 Active
68599-9573-03 78 g in 1 TUBE (68599-9573-3) 2026-04-23 Active
68599-9573-04 113.4 g in 1 TUBE (68599-9573-4) 2026-04-23 Active

Pack size FAQ

What quantity is in NDC 68599-9573-01?
NDC 68599-9573-01 contains 24.1 g — 24.1 g in 1 tube.
What is the difference between NDC 68599-9573-01 and NDC 68599-9573-02?
Both are Fluoride .22 g/g Paste — the drug itself is identical. NDC 68599-9573-01 is the 24.1 g package, while NDC 68599-9573-02 is the 42.5 g package.
What NDC number is used to bill for this package of Fluoride .22 g/g Paste?
Bill NDC 68599-9573-01 — the 11-digit billing format is 68599957301. 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

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 FDA registers it as 68599-9573-1, 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: 68599-9573-01, written without dashes as 68599957301. 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 68599-9573-01, the first segment (68599) is the labeler code FDA assigned to McKesson; the middle segment (9573) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 McKesson. 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 3 other package presentations of this same product, including 42.5 g (68599-9573-02), 78 g (68599-9573-03), 113.4 g (68599-9573-04). 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?
McKesson 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.

📄 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
🎯 Indications and Usage 8 words ▾

Uses Aids in the prevention of dental cavities.

⏱️ Dosage and Administration 66 words ▾

Directions Adults and children 2 years & older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. Do not swallow. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing, use a pea-sized amount). Supervise children's brushing until good habits are established. Children under 2 years: Consult a dentist or doctor.

⚠️ Warnings 31 words ▾

Warnings Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

🧪 Active Ingredient 13 words ▾

Active ingredient (in each gram) Sodium Fluoride - 0.243% (0.15% w/v fluoride ion)

🧪 Inactive Ingredients 29 words ▾

Inactive ingredients Sorbitol, Silica, Treated Water, Glycerin, PEG-32, Sodium Lauryl Sulfate, Flavor, Titanium Dioxide, Cellulose Gum, Carrageenan, Trisodium Phosphate, Sodium Saccharin, Sodium Benzoate, Tetrasodium Pyrophosphate, FD&C Blue # 1.

🎯 Purpose 2 words ▾

Purpose Anticavity

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 68599-9571-01 · McKesson 68605-1040-02 · ABBE →
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.