HAPEE GUMTECT GUM CARE SODIUM MONOFLUOROPHOSPHATE .15 g/100g Gel, Dentifrice
by LAMOIYAN CORPORATION · 72 CARTON in 1 BOX (GS1:14800034013259) / 1 TUBE in 1 CARTON (GS1:4800034013252) / 151 g in 1 TUBE (82426-153-01)
NDC 1480003401325
This package
Contains151 g in 1 tube
Pack sizes2 compare ↓
Also comes in:
151 g 82426-0153-01
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 →
🆔 Identity & classification
Product NDC
82426-0153
11-digit billing NDC
1480003401325
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 MONOFLUOROPHOSPHATE
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?
Hapee Gumtect is a toothpaste gel marketed as an over-the-counter monograph product under FDA's established rules for oral care products. It contains sodium monofluorophosphate, a fluoride compound commonly used in toothpastes to help strengthen tooth enamel and reduce cavity formation. This product is applied topically to the teeth and gums during regular brushing.
Patient education
Supplement & herbal interactions
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.
💬 Questions about SODIUM MONOFLUOROPHOSPHATE?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 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.
Inactive-ingredient data isn’t available for this listing.
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.
💲 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 system | Per g | Per 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:
151 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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Colgate Optic White Pro Series Enamel Renewal Soothing Mint 1.5 mg/g 35000-0791-62 | Colgate-Palmolive | 2 tubes | — | — | FDA listed | — |
| Colgate Optic White Pro Series High Impact White 1.5 mg/g 35000-0792-63 | Colgate-Palmolive | 1 tube | — | — | FDA listed | — |
| Colgate Optic White Advanced Enamel Strength 1.5 mg/g 35000-0921-32 | Colgate-Palmolive | 1 tube | — | — | FDA listed | — |
| Colgate Optic White Advanced Oxygenating White 1.5 mg/g 35000-0933-32 | Colgate-Palmolive | 1 tube | — | — | FDA listed | — |
| Colgate Optic White Advanced Vibrant Clean 1.5 mg/g 35000-0979-32 | Colgate-Palmolive | 1 tube | — | — | Discontinued | — |
| Colgate Optic White Pro Series Hi White 1.5 mg/g 65954-0841-63 | Mission | 1 tube | — | — | FDA listed | — |
| Colgate Optic White Pro Series 11.4 mg/g 65954-0845-62 | Mission | 2 tubes | — | — | FDA listed | — |
| Crest 3D White Advanced 1.7 mg/g 69423-0752-30 | The | 1 tube | — | — | FDA listed | — |
| Crest 3D White Brilliance Pro Ultra White 1.7 mg/g 69423-0760-30 | The | 1 tube | — | — | FDA listed | — |
| ARC 2 in 1 Whitening and Anticavity 1.7 mg/g 69423-0837-30 | The | 1 tube | — | — | FDA listed | — |
| Crest 3D White Brilliance Advanced Whitening Fresh Mint 1.7 mg/g 69423-0959-04 | The | 1 cello | — | — | FDA listed | — |
| Hapee Explosive Menthol Red 150 .15 g/100g 1480003401156 | LAMOIYAN | 1 tube | — | — | FDA listed | — |
| Hapee Fresh And Cool White 150 .15 g/100g 1480003401136 | LAMOIYAN | 1 tube | — | — | FDA listed | — |
| Hapee Fresh And Cool White 100 .15 g/100g 1480003401135 | LAMOIYAN | 1 tube | — | — | FDA listed | — |
| Hapee Gumtect Gum Care .15 g/100g 1480003401325 | LAMOIYAN | 1 tube | — | — | FDA listed | — |
| Hapee Fresh Green Outburst 100 .15 g/100g 1480003401165 | LAMOIYAN | 1 tube | — | — | FDA listed | — |
| Hapee Fresh Green Outburst 150 .15 g/100g 1480003401166 | LAMOIYAN | 1 tube | — | — | FDA listed | — |
| Hapee Outrageous Blue Chill 150 .15 g/100g 1480003401336 | LAMOIYAN | 1 tube | — | — | FDA listed | — |
| Crest 3D White Deep Stain Remover Dazzling Mint 2 mg/g 84126-0610-21 | The | 1 tube | — | — | FDA listed | — |
| Crest 3D White Deep Stain Remover Ultra White 2 mg/g 84126-0611-02 | The | 2 tubes | — | — | FDA listed | — |
| Crest 3D White Brilliance Pro Ultra White 1.7 mg/g 84126-0616-38 | The | 1 tube | — | — | FDA listed | — |
| Crest 3D White Deep Stain Remover Brilliant White 2 mg/g 84126-0626-03 | The | 2 tubes | — | — | FDA listed | — |
| Crest 3D White Deep Stain Remover Enamel Strength 2 mg/g 84126-0644-21 | The | 1 tube | — | — | FDA listed | — |
| Brush Buddies 2 VALUE PACK CAVITY PROTECTION ANTI-CAVITY FLUORIDE .15 g/100g 70108-0185-01 | Ashtel | 2 tubes | — | — | 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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 1480003401325 You're viewing this | 72 CARTON in 1 BOX (GS1:14800034013259) / 1 TUBE in 1 CARTON (GS1:4800034013252) / 151 g in 1 TUBE (82426-153-01) | 2022-05-27 | Active |
| 82426-0153-01 | 1 TUBE in 1 CARTON (82426-153-01) / 151 g in 1 TUBE | 2022-05-20 | Active |
Pack size FAQ
What quantity is in NDC 1480003401325?
NDC 1480003401325 is listed by the FDA — 72 carton in 1 box / 1 tube in 1 carton / 151 g in 1 tube.
🧭 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) | — 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. Both numbers identify this exact package. 1480003401325 is 1480003401325 written without dashes, in the fixed 11-digit (5-4-2) format used on insurance claims. The Identity section at the top of this page lists every 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 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 (82426-0153-01). 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 ▾
Use Helps protect against cavities
⏱️ Dosage and Administration ▾
Direction Brush thoroughly, preferably after each meal or at least twice a day. Do not swallow. Rinse and spit out after use.
⚠️ Warnings ▾
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 ▾
Active Ingredient Sodium Monofluorophosphate: 1.14% w/w (1,500 ppm fluoride as added) (0.15% w/w fluoride ion)
🧪 Inactive Ingredients ▾
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 ▾
Anti-cavity
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.