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Sodium fluoride Toothpaste .22 g/100g Cream — NDC 65517-2000-5 (Billing 65517-2000-05)

by DUKAL LLC · 1 TUBE in 1 BOX / 78 g in 1 TUBE

This is a package of Sodium fluoride Toothpaste .22 g/100g Cream from DUKAL LLC, no longer marketed (first marketed Nov 2013), no longer in the FDA NDC Directory.

NDC 65517-2000-05
🏷️ FDA NDC (as labeled) 65517-2000-5 billing pads the package segment with a zero
This package
Contains78 g in 1 tube Pack sizes8 compare ↓
Product page 65517-2000-00 Also comes in: 42 g 65517-2000-4 135 g 65517-2000-6 181 g 65517-2000-7 17 g 65517-2000-0 24 g 65517-2000-1 42 g 65517-2000-2 78 g 65517-2000-3
OTC Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 65517-2000-5 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
65517 labeler · 2000 product · 5 package
Barcode (UPC-A, from the NDC)
3 6551720005 4
FDA record last changed
Jul 24, 2026
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jul 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65517-2000-5
Product NDC 65517-2000
11-digit billing NDC 65517200005
RxCUI 245598
UNII 8ZYQ1474W7
Application # M022
SPL Set ID 460c0f54-367a-4300-b066-5071d718ea73
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Jul 2026)
Marketing start 2013-11-13
Marketing end 2026-07-31
Route ORAL
Dosage form CREAM
Substance SODIUM FLUORIDE
Quick answers
  • RxCUI (RxNorm): 245598
Why two NDCs? The FDA registers this code as 65517-2000-5 — 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 → 65517-2000-05. 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

🧪 What is this product?

This is an over-the-counter toothpaste cream containing sodium fluoride, marketed under FDA's monograph rules for oral care products. Sodium fluoride is commonly used in dental products to help strengthen tooth enamel and reduce tooth decay. The cream is applied topically in the mouth during brushing as part of a regular oral hygiene routine.

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: 42 g 135 g 181 g 17 g 24 g 42 g 78 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
65517-2000-00 65517-2000-0 Main listing 17 g in 1 TUBE 2015-02-19 Jul 31, 2026 Discontinued by firm
65517-2000-01 65517-2000-1 24 g in 1 TUBE 2015-02-19 Jul 31, 2026 Discontinued by firm
65517-2000-02 65517-2000-2 42 g in 1 TUBE 2015-02-19 Jul 31, 2026 Discontinued by firm
65517-2000-03 65517-2000-3 78 g in 1 TUBE 2015-02-19 Jul 31, 2026 Discontinued by firm
65517-2000-04 65517-2000-4 1 TUBE in 1 BOX / 42 g in 1 TUBE 2015-02-19 Jul 31, 2026 Discontinued by firm
65517-2000-05 You're viewing this 1 TUBE in 1 BOX / 78 g in 1 TUBE 2015-02-19 — Discontinued by firm
65517-2000-06 65517-2000-6 1 TUBE in 1 BOX / 135 g in 1 TUBE 2015-02-19 — Discontinued by firm
65517-2000-07 65517-2000-7 1 TUBE in 1 BOX / 181 g in 1 TUBE 2015-02-19 Jul 31, 2026 Discontinued by firm

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 box / 78 g in 1 tube.
What NDC number is used to bill for this package of Sodium fluoride Toothpaste .22 g/100g Cream?
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
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/100gthis 65517-2000-05 DUKAL 1 tube — — 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/g 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

🏛️
2013
On the market since
Nov 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.

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.

Manufacturer & labeler

LabelerDUKAL LLC
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code65517
First marketedNov 2013
Product typeHuman Otc Drug
Portfolio31 products on file

More NDCs from DUKAL LLC labeler code 65517

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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 8 words ▾

Use aids in the prevention of dental cavities

⏱️ Dosage and Administration 57 words ▾

Directions Adults and children 2 years: and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician. Children under 6 years: To minimize swallowing use a pea sized amount and supervise brushing until good habits are established. Children under 2 years: Ask a doctor or physician.

⚠️ Warnings 39 words ▾

Warnings Section Warnings Keep out of reach of children Keep out of reach of children under six years of age. If you accidently swallow more than used for brushing seek professional assistance or contact a Poison Control Center immediately

🧪 Active Ingredient 5 words ▾

Active ingredient Sodium fluoride 0.22%

🧪 Inactive Ingredients 18 words ▾

Inactive ingredients calcium carbonate,water,sorbitol, sodium lauryl sulfate, silica, carboxymethyl cellulose, flavor, potassium nitrate, sodium benzoate, sodium saccharin, menthol

🎯 Purpose 2 words ▾

Purpose Anticavity

📄 Keep Out of Reach of Children 36 words ▾

Keep out of reach of children Keep out of reach of children under six years of age. If you accidently swallow more than used for brushing seek professional assistance or contact a Poison Control Center immediately

📄 Package Label / Principal Display Panel 40 words ▾

Principal Display Panel - DawnMist Fluoride Toothpaste

0.6OZ Tube Label DawnMist ® NDC: 65517-2000-0 ORAL CARE Fluoride Toothpaste CAVITY FIGHTING FORMULA FRESH MINT FLAVOR

0.6OZ. (17 g) Principal Display Panel - DawnMist Fluoride Toothpaste

0.6 OZ Tube Label

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

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

Medicare Part D (outpatient prescription) spending for Sodium Fluoride — the program that covers self-administered drugs. 6 manufacturers.
⚠️ 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 Sodium 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
$487K
Claims incl. refills
44K
Beneficiaries
34K
Spend / beneficiary
$14.31
Spend / claim
$11.07
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.

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 Sodium fluoride (this brand).

Top reported reactions

Pyrexia172
Weight Increased162
Nausea160
Vomiting159
Fatigue158
Pain158
Nasopharyngitis155

Age at onset

Child16
Adolescent6
Adult74
Elderly77

Reporter sex

0 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 No longer marketed (per FDA listing data)
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 "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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 7 other package presentations of this same product, including 1 tube (65517-2000-04), 1 tube (65517-2000-06), 1 tube (65517-2000-07). 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?
DUKAL 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 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.
← 65517-1023-01 · Dukal 65517-2004-00 · Dukal →
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.