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Enamelon Preventive Treatment stannous fluoride .004 g/g Gel — NDC 48783-500-40 (Billing 48783-0500-40)

by Premier Dental Products Company · 1 TUBE in 1 CARTON / 113 g in 1 TUBE

This is a package of Enamelon Preventive Treatment stannous fluoride .004 g/g Gel from Premier Dental Products Company, marketed since Jan 2014 and currently FDA-listed. It is this product's only package size.

NDC 48783-0500-40
🏷️ FDA NDC (as labeled) 48783-500-40 billing pads the product segment with a zero
OTC 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) 48783-500-40
Product NDC 48783-500
11-digit billing NDC 48783050040
RxCUI 237847
UNII 3FTR44B32Q
Application # M021
SPL Set ID 04c3f178-7905-404d-9ac2-67c453287ddf
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-01-01
Route DENTAL
Dosage form GEL
Substance STANNOUS FLUORIDE
Quick answers
  • RxCUI (RxNorm): 237847
Why two NDCs? The FDA registers this code as 48783-500-40 — 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 → 48783-0500-40. 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
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?

Enamelon Preventive Treatment is a dental gel containing stannous fluoride, an over-the-counter monograph product applied directly to the teeth. Stannous fluoride is typically used in oral care products to help strengthen tooth enamel and reduce the risk of tooth decay. This gel form allows the active ingredient to contact tooth surfaces for topical fluoride protection.

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
48783-0500-40 You're viewing this Main listing 1 TUBE in 1 CARTON / 113 g in 1 TUBE 2014-01-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Gel-Kam Fruit and Berry 1 mg/g 00126-0165-93 Colgate 1 tube — — FDA listed —
Gel-Kam Mint 1 mg/g 00126-0192-93 Colgate 1 tube — — FDA listed —
Enamelon Preventive Treatment .004 g/gthis 48783-0500-40 Premier 1 tube — — FDA listed —
Just For Kids .969 mg/g 48878-4020-03 Solventum 1 tube — — FDA listed —
Just For Kids .969 mg/g 48878-4070-03 Solventum 1 tube — — FDA listed —
Ionite H .4 mg/100g 53045-0270-04 Dharma 122 g — — FDA listed —
Ionite H .4 mg/100g 53045-0271-04 Dharma 122 g — — FDA listed —
Kids Choice .12 g/120g 63783-0005-04 Massco 120 g — — FDA listed —
Kids Choice .12 g/120g 63783-0006-04 Massco 120 g — — FDA listed —
Kids Choice .12 g/120g 63783-0008-04 Massco 120 g — — FDA listed —
Kids Choice .12 g/120g 63783-0009-04 Massco 120 g — — FDA listed —
Doctors Choice .12 g/120g 63783-0011-04 Massco 120 g — — FDA listed —
Kids Choice .12 g/120g 63783-0015-04 Massco 120 g — — FDA listed —
Gelato Homecare .116 g/120g 68400-0201-04 Mycone 120 g — — FDA listed —
Gelato Homecare .116 g/120g 68400-0205-04 Mycone 120 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

🏛️
2014
On the market since
Jan 2014
📍
2026
Currently FDA-listed
12 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 23OV73Q5G9
    Acesulfame potassium is an artificial sweetener that tastes about 200 times sweeter than sugar. It's added to medicines to improve taste without adding calories or affecting blood sugar.
  • UNII WAT0DDB505
    Calcium sulfate is a mineral compound used as a filler and binder in tablets and capsules. It helps give the medicine its solid structure and ensures consistent dosing.
  • UNII 5216H1HX5F
    A synthetic polymer that functions as a binder and viscosity agent in pharmaceutical formulations. It helps hold tablet ingredients together and thickens liquid medicines to achieve the desired consistency and stability.
  • UNII 5OCF3O11KX
    A plant-derived surfactant made from coconut oil. It helps mix oil and water ingredients together in the formulation and can improve how the medicine spreads or feels on the skin.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • 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 LIJ19P3L6F
    Lauroyl sarcosine is a mild, plant-derived cleaning agent. In medicines, it acts as a surfactant and emulsifier to help mix oil and water-based ingredients and improve product texture and stability.
  • UNII TUF2IVW3M2
    Poloxamer 407 is a synthetic polymer made from ethylene oxide and propylene oxide. In medicines, it acts as a thickener, emulsifier, and solubilizer to help mix ingredients and create the right texture.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • 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 3980JIH2SW
    A salt form of phosphoric acid that acts as a buffer and pH adjuster in medicines. It helps keep the product at the correct acidity level for stability and effectiveness.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.

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

The official label also statesAcesulfame K, calcium/sodium maleate methyl vinyl ether copolymer, calcium sulfate, cocamidopropyl betaine, dimethicone, flavors, glycerin, lauroyl-sarcosine, monosodium phosphate, poloxamer 407, polyethylene glycol, silica, sucralose

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

LabelerPremier Dental Products Company
FDA applicationM021 (OTC MONOGRAPH DRUG)
Labeler code48783
First marketedJan 2014
Product typeHuman Otc Drug
Portfolio4 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.

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 37 words ▾

Uses Aids in the prevention of cavities Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact Helps prevent gingivitis Helps interfere with the harmful effects of plaque associated with gingivitis

⏱️ Dosage and Administration 98 words ▾

Directions Adults and children 6 years of age or older: Use once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out.

Do not swallow the gel. Do not rinse, eat or drink for 30 minutes after brushing. Instruct children under 12 years of age in the use of this product (to minimize swallowing).

Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Consult a dentist or doctor.

⚠️ Warnings 121 words ▾

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not use if gingivitis, bleeding, or redness persists for more than 2 weeks, see your dentist. See your dentist immediately if you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth.

These may be signs or symptoms of periodontitis, a serious form of gum disease. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. Stop use and ask a dentist if the problem persists or worsens.

Do not use this product for sensitivity relief longer than 4 weeks unless recommended by a dentist or doctor.

🧪 Active Ingredient 9 words ▾

Active ingredient Stannous fluoride 0.40% (0.15% w/v fluoride ion)

🧪 Inactive Ingredients 26 words ▾

Inactive ingredients Acesulfame K, calcium/sodium maleate methyl vinyl ether copolymer, calcium sulfate, cocamidopropyl betaine, dimethicone, flavors, glycerin, lauroyl-sarcosine, monosodium phosphate, poloxamer 407, polyethylene glycol, silica, sucralose

🎯 Purpose 3 words ▾

Purpose Anticavity/Sensitivity Relief/Antigingivitis

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

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 — 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 "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 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 Premier Dental Products Company. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Premier Dental Products Company 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.
← 48783-0113-08 · Premier 48783-0520-08 · Premier →
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.