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FluoriMax 5000 Sensitive 1.1% Sodium Fluoride with 5% Potassium Nitrate Toothpaste 1.1 g/100g; 5 g/100g Paste, Dentifrice, 96 g — NDC 57511-0503-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

FluoriMax 5000 Sensitive 1.1% Sodium Fluoride with 5% Potassium Nitrate Toothpaste 1.1 g/100g; 5 g/100g Paste, Dentifrice, 96 g — NDC 57511-0503-1 (Billing 57511-0503-01)

by Elevate Oral Care · 96 g in 1 TUBE

This is a package of 96 g of FluoriMax 5000 Sensitive 1.1% Sodium Fluoride with 5% Potassium Nitrate Toothpaste 1.1 g/100g; 5 g/100g Paste, Dentifrice from Elevate Oral Care, marketed since Jun 2022 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 57511-0503-01
🏷️ FDA NDC (as labeled) 57511-0503-1 billing pads the package segment with a zero
This package
Contains96 g Pack sizes2 compare ↓
Main listing for product 57511-0503 · Also comes in: 2 tubes 57511-0503-2
Rx only On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 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) 57511-0503-1
Product NDC 57511-0503
11-digit billing NDC 57511050301
NCPDP billing unit GM — per gram (weight)
RxCUI 637365, 2603764
UNII 8ZYQ1474W7, RU45X2JN0Z
SPL Set ID d9f232c0-d154-536b-e053-2995a90af37d
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-06-15
Route TOPICAL
Dosage form PASTE, DENTIFRICE
Substance SODIUM FLUORIDE; POTASSIUM NITRATE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 88409902774420
GPI class FluoriMax 5000 Sensitive
GCN Seq No 079751
GCN 46306
HICL code 017889
Ingredient (HICL) Sodium Fluoride/Potassium Nit
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D2
Therapeutic class — intermediate (HIC2) Drugs Acting On Teeth
HIC3 code D2A
Therapeutic class — specific (HIC3) Fluoride Preparations
AHFS code 34:04.00.00
AHFS class Nutritional Supplements
FDB label name FLUORIMAX 5000 1.1% TOOTHPASTE
FDB brand name Fluorimax 5000 Sensitive
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 079751
  • GCN: 46306
  • GPI-14 (Medi-Span): 88409902774420
  • HICL (First Databank): 017889
  • AHFS class code: 34:04.00.00
  • RxCUI (RxNorm): 637365
Why two NDCs? The FDA registers this code as 57511-0503-1 — 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 → 57511-0503-01. 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.

Clinical

Label name FLUORIMAX 5000 1.1% TOOTHPASTE Ingredient Sodium Fluoride/Potassium Nit
🧪 What is this product?

FluoriMax 5000 Sensitive is a toothpaste applied topically to the teeth and gums. It contains sodium fluoride, which is typically used in dental products to help strengthen tooth enamel and reduce cavity formation. The product also includes potassium nitrate, an ingredient commonly used in toothpastes designed for sensitive teeth to help reduce discomfort. This product is marketed without an approved FDA application.

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 tubes
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
57511-0503-01 You're viewing this Main listing 96 g in 1 TUBE 2020-08-31 — Active
57511-0503-02 57511-0503-2 2 TUBE in 1 BOX / 96 g in 1 TUBE 2022-06-15 — Active

Pack size FAQ

What quantity is in this package?
This package contains 96 g — 96 g in 1 tube.
What NDC number is used to bill for this package of FluoriMax 5000 Sensitive 1.1% Sodium Fluoride with 5% Potassium Nitrate Toothpaste 1.1 g/100g; 5 g/100g 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
Sodium Fluoride 5000 ppm Sensitive 5.8 mg/mL; 57.5 mg/mL 11527-0704-42 Sheffield 1 tube $0.116 — Availability likely —
Sodium Fluoride 5000 ppm Enamel Protect 57.5 mg/mL; 5.8 mg/mL 11527-0745-34 Sheffield 1 tube $0.116 — Availability likely —
Denta 5000 Plus Sensitive 5.8 mg/mL; 57.5 mg/mL 16571-0823-10 Rising 100 ml $0.116 — Availability likely —
Sodium Fluoride and Potassium Nitrate 5.8 mg/mL; 57.5 mg/mL 69367-0318-01 Westminster 1 tube $0.116 — Availability likely —
PreviDent 5000 Enamel Protect 5.8 mg/mL; 57.5 mg/mL 00126-0022-92 Colgate 100 ml — — FDA listed —
PreviDent 5000 Sensitive 5.8 mg/mL; 57.5 mg/mL 00126-0070-61 Colgate 100 ml — — FDA listed —
Acclean Anti-Cavity Sensitivity Relief 5 g/100g; 1.1 g/100g 00404-0174-04 Henry 1 tube — — FDA listed —
Ionite H 1.1 mg/100g; 5 mg/100g 53045-0280-04 Dharma 122 g — — FDA listed —
Ionite H 1.1 mg/100g; 5 mg/100g 53045-0281-04 Dharma 122 g — — FDA listed —
FluoriMax 5000 Sensitive 1.1 g/100g; 5 g/100gthis 57511-0503-01 Elevate 96 g — — FDA listed —
Fluoridex 5 mg/g; 50 mg/g 59883-0030-04 DENT-MAT 1 tube — — FDA listed —
Fluoridex 50 mg/g; 5 mg/g 59883-0031-04 DENT-MAT 1 tube — — FDA listed —
Pro-Sys 5 g/100g; 1.1 g/100g 66975-0778-01 Benco 113 g — — FDA listed —
Pro-Sys 1.1 g/100g; 5 g/100g 66975-0779-01 Benco 113 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

🏛️
2022
On the market since
Jun 2022
📍
2026
Currently FDA-listed
4 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

Color white
ShapeRound
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 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 Y6O7T4G8P9
    Hydrated silica is a fine powder form of silicon dioxide with absorbed water. It works as an anti-caking agent and absorbent in medicines, helping powders stay free-flowing and preventing clumping.
  • UNII 4J9FJ0HL51
    Potassium phosphate, monobasic is a salt compound used in medicines as a pH buffer and electrolyte source. It helps stabilize the acidity level of liquid and powdered formulations.
  • UNII FST467XS7D
    Saccharin is an artificial sweetener derived from benzoic sulfinilanide. It's added to medicines to improve taste and make them easier to take, especially in liquid or chewable formulations.
  • 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 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.

7 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

LabelerElevate Oral Care
Labeler code57511
First marketedJun 2022
Product typeHuman Prescription Drug
Portfolio10 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.

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.
⚠️ Warnings 📖 Instructions for Use 📄 Package Label / Principal Display Panel
⚠️ Warnings 2 words ▾

Warnings Warnings

📖 Instructions for Use 5 words ▾

Directions Instructions for Use Directions

📄 Package Label / Principal Display Panel 9 words ▾

Package Label and Instructions for use Primary Package Label

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

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 Elevate Oral Care. 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 tubes (57511-0503-02). 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?
Elevate Oral Care 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.
← 57511-0202-01 · Elevate 57511-0504-01 · Elevate →
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.