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Just Right 5000 1.1% Sodium Fluoride Toothpaste 1.1 g/100g Gel, Dentifrice, 97 g — NDC 57511-0001-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Just Right 5000 1.1% Sodium Fluoride Toothpaste 1.1 g/100g Gel, Dentifrice, 97 g — NDC 57511-0001-1 (Billing 57511-0001-01)

by Elevate Oral Care · 97 g in 1 TUBE

This is a package of 97 g of Just Right 5000 1.1% Sodium Fluoride Toothpaste 1.1 g/100g Gel, Dentifrice from Elevate Oral Care, marketed since Aug 2020 and currently FDA-listed. It is this product's only package size.

NDC 57511-0001-01
🏷️ FDA NDC (as labeled) 57511-0001-1 billing pads the package 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 57511-0001-1
Product NDC 57511-0001
11-digit billing NDC 57511000101
NCPDP billing unit GM — per gram (weight)
RxCUI 392038
UNII 8ZYQ1474W7
SPL Set ID ac24342d-382e-6fc2-e053-2a95a90acd69
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-08-05
Route TOPICAL
Dosage form GEL, DENTIFRICE
Substance SODIUM FLUORIDE

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

GPI-14 88402020004418
GPI class Just Right 5000
GCN Seq No 060385
GCN 26528
HICL code 001127
Ingredient (HICL) Fluoride (Sodium)
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 JUST RIGHT 5000 1.1% TOOTHPSTE
FDB brand name Just Right 5000
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 060385
  • GCN: 26528
  • GPI-14 (Medi-Span): 88402020004418
  • HICL (First Databank): 001127
  • AHFS class code: 34:04.00.00
  • RxCUI (RxNorm): 392038
Why two NDCs? The FDA registers this code as 57511-0001-1 — 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 → 57511-0001-01. 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.

Clinical

Label name JUST RIGHT 5000 1.1% TOOTHPSTE Ingredient Fluoride (Sodium)
📖 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?

Just Right 5000 is a topical gel toothpaste that contains 1.1% sodium fluoride. Sodium fluoride is commonly used in dental products to help strengthen tooth enamel and reduce cavity formation. This product is an unapproved drug marketed without an approved FDA application. It is applied topically to the teeth during regular oral hygiene routines.

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
57511-0001-01 You're viewing this Main listing 97 g in 1 TUBE 2020-08-05 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Denta 5000 Plus 1.1 g/100g 16571-0814-50 Rising 51 g $0.063 — Availability likely —
Sodium Fluoride 5000 Plus 5 mg/g 69367-0309-51 Westminster 1 tube $0.063 — Availability likely —
SF 5000 Plus 5 mg/g 60258-0150-01 Cypress 1 tube $0.093 — FDA listed —
Sodium Fluoride 5000 ppm Fruit 6 mg/mL 11527-0730-44 Sheffield 1 tube $0.097 — Availability likely —
Sodium Fluoride 5000 ppm Spearmint 6 mg/mL 11527-0750-43 Sheffield 1 tube $0.097 — Availability likely —
Sodium Fluoride 5000 ppm Dry Mouth 6.1 mg/mL 11527-0755-34 Sheffield 1 tube $0.097 — Availability likely —
Sodium Fluoride 5000 PPM 6 mg/mL 69367-0311-01 Westminster 100 ml $0.097 — Availability likely —
Sodium Fluoride 5000 PPM 6 mg/mL 69367-0312-01 Westminster 100 ml $0.097 — Availability likely —
DentaGel 1.1 g/100g 16571-0815-60 Rising 56 g $0.108 — Availability likely —
PreviDent 5000 Dry Mouth 6.1 mg/mL 00126-0016-61 Colgate 100 ml — — FDA listed —
PreviDent 5000 Booster Plus Fruitastic 6 mg/mL 00126-0072-92 Colgate 100 ml — — FDA listed —
PreviDent 5000 Booster Plus Spearmint 6 mg/mL 00126-0074-92 Colgate 100 ml — — FDA listed —
PreviDent Fresh Mint 5 mg/g 00126-0088-02 Colgate 1 tube — — FDA listed —
PreviDent 5000 Plus Fruitastic 11 mg/g 00126-0286-66 Colgate 1 tube — — FDA listed —
PreviDent 5000 Plus Spearmint 11 mg/g 00126-0287-66 Colgate 1 tube — — FDA listed —
PreviDent Very Berry 5 mg/g 00126-0288-02 Colgate 1 tube — — FDA listed —
PreviDent OrthoDefense 6 mg/mL 00126-0289-92 Colgate 100 ml — — FDA listed —
PreviDent 5000 Kids 6 mg/mL 00126-0311-92 Colgate 100 ml — — FDA listed —
Acclean Anti-Cavity 1.1 g/100g 00404-0173-04 Henry 1 tube — — FDA listed —
Sodium Flouride 5 mg/mL 42291-0741-51 AvKARE 1 tube — — FDA listed —
Clinpro 5000 5 mg/g 48878-3120-04 Solventum 1 tube — — FDA listed —
Clinpro 5000 5 mg/g 48878-3130-04 Solventum 1 tube — — FDA listed —
Clinpro 5000 5 mg/g 48878-3140-04 Solventum 1 tube — — FDA listed —
Just Right 5000 1.1 g/100gthis 57511-0001-01 Elevate 97 g — — FDA listed —
Just Right 5000 1.1 g/100g 57511-0002-01 Elevate 97 g — — FDA listed —
Just Right 5000 1.1 g/100g 57511-0003-01 Elevate 97 g — — FDA listed —
Allday 5000 1.1 g/100g 57511-0005-01 Elevate 2 tubes — — FDA listed —
FluoriMax 5000 1.1 g/100g 57511-0504-01 Elevate 96 g — — FDA listed —
PRO Gel 5000 Mint 5000 ug/g 61578-0215-01 DENTAL 68 g — — FDA listed —
PRO Gel 5000 Citrus 5000 ug/g 61578-0216-01 DENTAL 68 g — — FDA listed —
Neutramaxx 5000 Plus Turbo 1.1 g/112g 63783-0500-04 Massco 112 g — — FDA listed —
Neutramaxx 5000 Tcp 1.1 g/112g 63783-0501-04 Massco 112 g — — FDA listed —
Neutra Maxx 5000 1.428 g/120g 63783-0504-06 Massco 120 g — — FDA listed —
Prosys .11 g/100g 66975-0782-01 Benco 113 g — — FDA listed —
Super Mint Prescription 1.1 g/100g 83729-0102-10 SuperMouth, 1 tube — — FDA listed —
Super Chocolate Prescription 1.1 g/100g 83729-0103-10 SuperMouth, 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

🏛️
2020
On the market since
Aug 2020
📍
2026
Currently FDA-listed
6 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 blue
ShapeRound
FlavorBubble Gum
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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
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

LabelerElevate Oral Care
Labeler code57511
First marketedAug 2020
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 10 words ▾

Primary Package label and instruction 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) — 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 "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.
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.
← 57483-0955-05 · Innovus 57511-0002-01 · 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.