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EverSmile AlignerFresh Enamel Guard SODIUM FLUORIDE .225 mg/mL Rinse — NDC 72655-300-01 (Billing 72655-0300-01)

by Everbrands, Inc. · 1 BOTTLE, PUMP in 1 PACKAGE / 50 mL in 1 BOTTLE, PUMP

This is a package of EverSmile AlignerFresh Enamel Guard SODIUM FLUORIDE .225 mg/mL Rinse from Everbrands, Inc., marketed since Feb 2022 and currently FDA-listed. It is this product's only package size.

NDC 72655-0300-01
🏷️ FDA NDC (as labeled) 72655-300-01 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) 72655-300-01
Product NDC 72655-300
11-digit billing NDC 72655030001
RxCUI 2597250
UNII 8ZYQ1474W7
Application # M022
SPL Set ID 7b3d0114-dac0-4370-8545-922ec018018e
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-02-16
Route ORAL
Dosage form RINSE
Substance SODIUM FLUORIDE
Quick answers
  • RxCUI (RxNorm): 2597250
Why two NDCs? The FDA registers this code as 72655-300-01 — 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 → 72655-0300-01. 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

🧪 What is this product?

EverSmile AlignerFresh Enamel Guard is an over-the-counter oral rinse containing sodium fluoride as its active ingredient. Sodium fluoride is commonly used in dental rinses to help strengthen tooth enamel and reduce the risk of cavities. This product is marketed as an OTC monograph drug, meaning it follows FDA's established rules for this category of dental fluoride rinses rather than being individually approved.

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 eachPer 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
72655-0300-01 You're viewing this Main listing 1 BOTTLE, PUMP in 1 PACKAGE / 50 mL in 1 BOTTLE, PUMP 2022-02-16 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
EverSmile AlignerFresh Enamel Guard .225 mg/mLthis 72655-0300-01 Everbrands, 1 bottle — — FDA listed —
Eversmile TheraFoam .05 g/100mL 72655-0500-01 Everbrands, 1 bottle — — FDA listed —
Eversmile OrthoFoam Anticavity .05 g/100mL 72655-0600-01 Everbrands, 1 bottle — — 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
Feb 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.

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

LabelerEverbrands, Inc.
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code72655
First marketedFeb 2022
Product typeHuman Otc Drug
Portfolio7 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 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 7 words ▾

Uses aids in prevention of dental cavities

⏱️ Dosage and Administration 155 words ▾

Directions: Tray application Adults and children 12 yrs. of age and older: Dispense up to a full pump of foam inside each tray. Use the nozzle tip to cover all areas of the tray evenly with foam. Place form-filled trays back in mouth.

Spit out excess. No need to rinse as foam naturally dissipates. Do not swallow rinse.

Children under 12 years of age: consult a dentist or doctor. To rinse: Adults and children 12 years & older: Use twice a day after brushing your teeth with a toothpaste. Vigorously swish 2 pumps of rinse between your teeth for 1 minute and then spit out.

Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing. Instruct children under 12 years of age in good rinsing habits (to minimize swallowing).

Supervise children as necessary until capable of using without supervision. Children under 12 years of age: consult a dentist or doctor.

⚠️ Warnings 15 words ▾

Warnings Stop use and ask a dentist if oral irritation or tooth sensitivity occurs ​

🧪 Active Ingredient 9 words ▾

Active ingredient Sodium fluoride 0.05% (0.0225% w/v fluoride ion)

🧪 Inactive Ingredients 21 words ▾

Inactive Ingredients: Etidronic Acid, glycerin, hydrogen peroxide, menthe arvensis oil, PEG, PVP, sodium benzoate, sodium citrate, sodium lauryl sulfate. sucralose, water

🎯 Purpose 2 words ▾

Purpose Anticavity

📄 Keep Out of Reach of Children 26 words ▾

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a poison Control Center right away.

📄 Other Information 11 words ▾

Other Information store at controlled room temperature 68-77°F (20 - 25°C)

📄 Questions or Comments 4 words ▾

Questions? +1 (855) 595-2999

📄 Package Label / Principal Display Panel 37 words ▾

Package Label EverSmile® ALIGNERFRESH ENAMEL GUARD FLUORIDE FOAM 50 mL (1.69fl oz) Manufactured By EverBrands, Inc. 401 N Oak St. Inglewood, CA 90302 855 595-2999 [email protected] www.eversmilewhite.com Box Label Bottle Label res 300 Box 300 Bottle Label

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 EverSmile AlignerFresh Enamel Guard (this brand).

Top reported reactions

Pyrexia172
Weight Increased162
Nausea160
Vomiting159
Fatigue158
Pain158
Nasopharyngitis155

Age at onset

Child16
Adolescent6
Adult74
Elderly77

Reporter sex

1,067 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
2020 2022 2024 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

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) — 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.
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 Everbrands, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Everbrands, Inc. 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.
← 72655-0200-01 · Everbrands, 72655-0400-01 · Everbrands, →
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.