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HAPEE GUMTECT SENSITIVE 100 SODIUM MONOFLUOROPHOSPHATE .331 g/100g; 5 g/100g Gel, Dentifrice — NDC 82426-0154-01 package photo

HAPEE GUMTECT SENSITIVE 100 SODIUM MONOFLUOROPHOSPHATE .331 g/100g; 5 g/100g Gel, Dentifrice

by LAMOIYAN CORPORATION · 1 TUBE in 1 CARTON (82426-154-01) / 133 g in 1 TUBE
NDC 82426-0154-01
🏷️ FDA NDC (as labeled) 82426-154-01 billing pads the product segment with a zero
This package
Contains133 g in 1 tube Pack sizes2 compare ↓
Also comes in: 133 g 1480003401405
OTC On market Non-controlled
🗂️ Data synced Sep 17, 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

FDA NDC (as labeled) 82426-154-01
Product NDC 82426-154
11-digit billing NDC 82426015401
RxCUI 1038995
UNII C810JCZ56Q, RU45X2JN0Z, 8ZYQ1474W7
UPC 4800034011562, 4800034011661, 4800034011357, 4800034011364 +4 more
Application # M021
SPL Set ID 14c14694-6149-40a8-aff2-660d39f7e0c1
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-05-20
Route DENTAL
Dosage form GEL, DENTIFRICE
Substance SODIUM FLUORIDE; POTASSIUM NITRATE
Why two NDCs? The FDA registers this code as 82426-154-01 — 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 → 82426-0154-01. 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.

🏭 Manufacturer & labeler

LabelerLAMOIYAN CORPORATION
FDA applicationM021 (OTC MONOGRAPH DRUG)
Labeler code82426
First marketedMay 2022
Product typeHuman Otc Drug
Portfolio8 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.

🩺 Clinical

🧪 What is this product?

This is a fluoride toothpaste gel sold over the counter under FDA's OTC monograph rules for dentifrices. It contains sodium fluoride and potassium nitrate as active ingredients. Sodium fluoride is commonly used in toothpastes to help strengthen tooth enamel and reduce cavity formation. Potassium nitrate is typically included to help reduce tooth sensitivity by blocking sensation from reaching the tooth nerve.

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.

💊 What it looks like

Color white / red / green / blue
FlavorMenthol
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 JPF3YI7O34
    A natural oil derived from pine plants and other sources. It serves as a fragrance, flavor enhancer, and solvent in medicines, helping deliver active ingredients and improve taste or smell.
  • UNII 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
  • UNII 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII Q3JEK5DO4K
    Anethole is a natural aromatic compound that gives licorice and anise their distinctive flavor and scent. It's used in medicines as a flavoring agent to make the taste more pleasant.
  • 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 75GK9XIA8I
    Carvone is a naturally derived aromatic compound found in caraway and spearmint plants. In medications, it's used as a flavoring agent to improve taste and mask bitter or unpleasant flavors.
  • UNII RV6J6604TK
    Eucalyptol is a natural oil compound extracted from eucalyptus plants. In medicines, it serves as a flavoring agent and aromatic component to improve taste and smell.
  • UNII 3T8H1794QW
    Eugenol is a natural oil extracted from clove and other plants. It's used in medicines as a flavoring agent and to provide a mild anesthetic effect in topical products, particularly in dental formulations.
  • 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 9WZ3E2G6CL
    A menthol-derived compound used as a flavoring and fragrance agent in medicines. It provides a cooling or minty sensory effect to improve taste and aroma of oral formulations.
  • UNII 47MAJ1Y2NE
    A natural citrus-derived oil and flavoring agent. Used to enhance taste and aroma, improve ingredient dissolution, and serve as a solvent in liquid medicines and supplements.
  • UNII L7T10EIP3A
    A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
  • UNII 9NH5J4V8FN
    Menthone is a naturally derived compound from mint plants that provides a cooling sensation and minty flavor. It's used in medicines to improve taste and create a soothing sensation in oral products.
  • UNII H41B6Q1I9L
    A naturally derived antimicrobial compound found in plant oils. It's added to medicines as a preservative to help prevent bacterial and fungal growth and extend shelf life.
  • UNII NL4J9F21N9
    Polyethylene glycol 600 is a synthetic liquid polymer used as a solvent and humectant in medicines. It helps dissolve active ingredients and keeps products from drying out.
  • 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 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • 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 C3M81465G5
    Spearmint oil is a natural flavoring extract from spearmint plants. It's added to medicines to improve taste and mask bitter flavors, making medications easier to take.
  • 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.
  • 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 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.

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

The official label also statesSorbitol, Water, Hydrated Silica, Sodium Lauryl Sulfate, Flavor, PEG-12, Cellulose Gum, Sodium Saccharin, Methylparaben, Mica, Propylparaben, FD&C Red No.40

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.

💲 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: 133 g
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hapee Gumtect Sensitive 100 .331 g/100g; 5 g/100gthis 82426-0154-01 LAMOIYAN 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

🏛️
2022
On the market since
May 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.

🔬 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 SODIUM MONOFLUOROPHOSPHATE — the ingredient across all brands.

Top reported reactions

Fatigue38
Dyspnoea29
Nausea29
Diarrhoea27
Vomiting23
Malaise22
Dry Mouth21

Age at onset

Adult17
Elderly7

Reporter sex

335 reports
Male · 28%
Female · 72%
Unknown · 1%

Serious outcomes

Life-threatening18
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 9 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
1480003401405 72 CARTON in 1 BOX (GS1:14800034014058) / 1 TUBE in 1 CARTON (GS1:4800034014051) / 133 g in 1 TUBE (82426-154-01) 2022-05-27 Active
82426-0154-01 You're viewing this 1 TUBE in 1 CARTON (82426-154-01) / 133 g in 1 TUBE 2022-05-27 Active

Pack size FAQ

What quantity is in NDC 82426-0154-01?
NDC 82426-0154-01 is listed by the FDA — 1 tube in 1 carton / 133 g in 1 tube.
What NDC number is used to bill for this package of HAPEE GUMTECT SENSITIVE 100 SODIUM MONOFLUOROPHOSPHATE .331 g/100g; 5 g/100g Gel, Dentifrice?
Bill NDC 82426-0154-01 — the 11-digit billing format is 82426015401. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 ✓ 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 "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 FDA registers it as 82426-154-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 82426-0154-01, written without dashes as 82426015401. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 82426-0154-01, the first segment (82426) is the labeler code FDA assigned to LAMOIYAN CORPORATION; the middle segment (0154) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
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 LAMOIYAN CORPORATION. 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 1 tube (1480003401405). 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?
LAMOIYAN CORPORATION 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.

📄 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 5 words ▾

Use Helps protect against cavities

⏱️ Dosage and Administration 22 words ▾

Direction Brush thoroughly, preferably after each meal or at least twice a day. Do not swallow. Rinse and spit out after use.

⚠️ Warnings 34 words ▾

WARNINGS AND PRECAUTIONS SECTION Children of six years and younger: Use a pea-sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources, consult a dentist or doctor.

🧪 Active Ingredient 15 words ▾

Active Ingredient Sodium Monofluorophosphate: 1.14% w/w (1,500 ppm fluoride as added) (0.15% w/w fluoride ion)

🧪 Inactive Ingredients 21 words ▾

Inactive Ingredients Sorbitol, Water, Hydrated Silica, Sodium Lauryl Sulfate, Flavor, PEG-12, Cellulose Gum, Sodium Saccharin, Methylparaben, Mica, Propylparaben, FD&C Red No.40

🎯 Purpose 1 words ▾

Anti-cavity

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 1480003401325 · LAMOIYAN 1480003401165 · LAMOIYAN →
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.