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Neutramaxx 5000 Tcp Sodium Fluoride 1.1 g/112g Paste, Dentifrice, 112 g — NDC 63783-501-04 (Billing 63783-0501-04)

by Massco Dental A Division of Dunagin Pharmaceuticals · 112 g in 1 TUBE

This is a package of 112 g of Neutramaxx 5000 Tcp Sodium Fluoride 1.1 g/112g Paste, Dentifrice from Massco Dental A Division of Dunagin Pharmaceuticals, marketed since Aug 2011 and currently FDA-listed. It is this product's only package size.

NDC 63783-0501-04
🏷️ FDA NDC (as labeled) 63783-501-04 billing pads the product 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) 63783-501-04
Product NDC 63783-501
11-digit billing NDC 63783050104
RxCUI 392038, 1191716
UNII 8ZYQ1474W7
SPL Set ID f47cb584-eb8a-4297-ba32-5f435e85aacb
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-08-01
Route ORAL
Dosage form PASTE, DENTIFRICE
Substance SODIUM FLUORIDE
Quick answers
  • RxCUI (RxNorm): 392038
Why two NDCs? The FDA registers this code as 63783-501-04 — 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 → 63783-0501-04. 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?

Neutramaxx 5000 TCP is a fluoride-containing toothpaste (dentifrice) applied topically in the mouth. Sodium fluoride, its active ingredient, is commonly used in dental products to help strengthen tooth enamel and is typically included in toothpastes for oral hygiene routines. 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.
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
63783-0501-04 You're viewing this Main listing 112 g in 1 TUBE 2011-08-01 — 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/100g 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/112gthis 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

🏛️
2011
On the market since
Aug 2011
📍
2026
Currently FDA-listed
15 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.

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

  • UNII 05JZI7B19X
    A plant-based thickener made from cellulose that holds water and creates texture. It works as a binder and thickening agent to give the medicine its proper consistency and help ingredients blend together.
  • 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 Q662QK8M3B
    Polyethylene glycol 8000 is a synthetic polymer made from ethylene oxide. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the medicine.
  • 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 593YOG76RN
    A salt made from sodium and phosphate that helps regulate acidity and maintain proper pH balance in the medicine. It also acts as a buffer to keep the product stable.
  • 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 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 91D9GV0Z28
    A mineral salt made from calcium and phosphate. It acts as a filler to add bulk to the tablet or capsule, and helps bind ingredients together so the medicine holds its shape.
  • 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.

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

The official label also statesInactive Ingredients: Deionized Water, Sorbitol, Hydrated Silica, PEG, Carboxymethylcellulose, Xylitol, MonoSodium Phosphate, Titanium Dioxide, Mint Flavor, Sodium Saccharin, Tri-Calcium Phosphate

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

LabelerMassco Dental A Division of Dunagin Pharmaceuticals
Labeler code63783
First marketedAug 2011
Product typeHuman Prescription Drug
Portfolio12 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.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 23 words ▾

Indications and Usage Section NeutraMaxxtm 5000 with Tri-Calcium Phosphate is a self applied dentifrice for prevention of tooth decay, orthodontic decalcification and hypersensitivity

⏱️ Dosage and Administration 85 words ▾

Directions: Use As Directed Section This prescription dentifrice is recommended for adults and pediatric patients 6 years and older Apply a thin ribbon of NeutraMaxxtm 5000 TCP along the length of the toothbrush no more than "pea size" total dose. Brush for two minutes. After brushing ADULTS - Expectorate, do not eat for 30 minutes.

CHILDREN 6 YEARS OF AGE OR OLDER - Expectorate and rinse mouth with water. Use at bedtime in place of your regular toothpaste or as directed by your dental professional.

⚠️ Warnings 10 words ▾

Warning Section Warnings Do not swallow For topical use only

🧪 Active Ingredient 12 words ▾

Active Ingredient Section DRUG FACTS ACTIVE INGREDIENT 1.1 % NEUTRAL SODIUM FLUORIDE

🧪 Inactive Ingredients 23 words ▾

Inactive Ingredient Section Inactive Ingredients: Deionized Water, Sorbitol, Hydrated Silica, PEG, Carboxymethylcellulose, Xylitol, MonoSodium Phosphate, Titanium Dioxide, Mint Flavor, Sodium Saccharin, Tri-Calcium Phosphate

🎯 Purpose 11 words ▾

Purpose Section For prevention of tooth decay, orthodontic decalcification and hypersensitivity.

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 NEUTRAMAXX 5000 TCP (this brand).

Top reported reactions

Pyrexia172
Weight Increased162
Nausea160
Vomiting159
Fatigue158
Pain158
Nasopharyngitis155

Reporter sex

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

Serious outcomes

Death347
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 213 0
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

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 — Not published for this NDC No photo available yet for this listing.
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 Massco Dental A Division of Dunagin Pharmaceuticals. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Massco Dental A Division of Dunagin Pharmaceuticals 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.
← 63783-0500-04 · Massco 63783-0504-06 · Massco →
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.