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Made by Dentists Enamel Rebuilding Professional POTASSIUM NITRATE, SODIUM FLUORIDE 50 mg/g; 1.5 mg/g Paste — NDC 62776-003-01 (Billing 62776-0003-01)

by Fulijaya Manufacturing Sdn. Bhd · 1 TUBE in 1 CARTON / 120 g in 1 TUBE

This is a package of Made by Dentists Enamel Rebuilding Professional POTASSIUM NITRATE, SODIUM FLUORIDE 50 mg/g; 1.5 mg/g Paste from Fulijaya Manufacturing Sdn. Bhd, marketed since Jan 2024 and currently FDA-listed. It is this product's only package size.

NDC 62776-0003-01
🏷️ FDA NDC (as labeled) 62776-003-01 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

NDC database record

One package, one record: these facts belong to NDC 62776-003-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
62776 labeler · 003 product · 01 package
Package marketed since
Jan 1, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0850031970717
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 62776-003-01
Product NDC 62776-003
11-digit billing NDC 62776000301
RxCUI 1038929
UNII RU45X2JN0Z, 8ZYQ1474W7
UPC 0850031970717
Application # M022
SPL Set ID 178d7538-c178-b8ca-e063-6394a90a7d33
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-01-01
Route DENTAL
Dosage form PASTE
Substance POTASSIUM NITRATE; SODIUM FLUORIDE
Quick answers
  • RxCUI (RxNorm): 1038929
Why two NDCs? The FDA registers this code as 62776-003-01 — 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 → 62776-0003-01. 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.

Clinical

🧪 What is this product?

This is an over-the-counter dental paste marketed under FDA's OTC monograph rules. It contains potassium nitrate and sodium fluoride as active ingredients. Potassium nitrate is typically used to reduce tooth sensitivity, while sodium fluoride is commonly used to help strengthen tooth enamel and prevent tooth decay. The product is applied topically to the teeth as part of regular oral care.

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
62776-0003-01 You're viewing this Main listing 1 TUBE in 1 CARTON / 120 g in 1 TUBE 2024-01-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sensodyne Extra Whitening 50 mg/g; 1.11 mg/g 00135-0525-03 Haleon 1 tube — — FDA listed —
Aquafresh Sensitive Maximum Strength 50 mg/g; 1.1 mg/g 00135-0605-01 Haleon 1 tube — — FDA listed —
Sensodyne Extra Whitening Cool Mint 50 mg/g; 1.15 mg/g 00135-0643-01 Haleon 1 tube — — FDA listed —
Walgreens Sensitive Extra Whitening 5 g/100g; .15 g/100g 00363-1588-09 Walgreens 1 tube — — FDA listed —
TheraBreath .24 g/100g; 5 g/100g 10237-0273-04 Church 1 tube — — FDA listed —
Sensitive Teeth and Gums 2.43 mg/g; 50 mg/g 10237-0669-45 Church 1 tube — — FDA listed —
Target Sensitive Whitening TP 5 g/100g; .24 g/100g 11673-0237-79 Target 1 tube — — FDA listed —
Rite Aid Extra Whitening .15 g/100g; 5 g/100g 11822-5020-09 Rite 1 tube — — FDA listed —
Signature Care Enamel Guard Sensitive Gentle Whitening .15 g/100g; 5 g/100g 21130-0350-19 Safeway 1 tube — — FDA listed —
Signature Care Sensitive Maximum Strength .15 g/100g; 5 g/100g 21130-0351-19 Safeway 1 tube — — FDA listed —
Kroger Extra Whitening .15 g/100g; 5 g/100g 30142-0149-99 Kroger 1 tube — — FDA listed —
Kroger Enamel Protection Sensitive Gentle Whitening 5 g/100g; .15 g/100g 30142-0362-99 Kroger 1 tube — — FDA listed —
Colgate Sensitive plus Whitening 50 mg/g; 1.1 mg/g 35000-0023-34 Colgate-Palmolive 2 tubes — — FDA listed —
Colgate Sensitive Complete Protection 50 mg/g; 1.1 mg/g 35000-0024-21 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Sensitive Prevent and Repair 50 mg/g; 1.1 mg/g 35000-0128-60 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Sensitive Enamel Health 50 mg/g; 1.1 mg/g 35000-0130-60 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Sensitive Whitening 50 mg/g; 1.1 mg/g 35000-0131-34 Colgate-Palmolive 2 tubes — — FDA listed —
Colgate Sensitive Complete Protection 50 mg/g; 1.1 mg/g 35000-0132-21 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Optic White Stain Fighter Sens Relief 1.5 mg/g; 50 mg/g 35000-0998-60 Colgate-Palmolive 1 tube — — FDA listed —
Topco Associates LLC Maximum Strength .15 g/100g; 5 g/100g 36800-0364-10 Topco 1 tube — — FDA listed —
TopCare Sensitive Extra Whitening .15 g/100g; 5 g/100g 36800-0451-59 TOPCO 1 tube — — FDA listed —
Top Care Enamel Guard .15 g/100g; 5 g/100g 36800-0681-19 TOPCO 1 tube — — FDA listed —
HEB Sensitive Extra Whitening Twin .15 g/100g; 5 g/100g 37808-0237-10 HEB 2 tubes — — FDA listed —
HEB Extra Whitening .15 g/100g; 5 g/100g 37808-0681-19 HEB 1 tube — — Discontinued —
HEB Extra Whitening .15 g/100g; 5 g/100g 37808-0961-19 HEB 1 tube — — FDA listed —
Meijer Enamel Guard .15 g/100g; 5 g/100g 41250-0514-09 Meijer 1 tube — — FDA listed —
Care One Maximum Strength .15 g/100g; 5 g/100g 41520-0415-09 American 1 tube — — FDA listed —
Care One Maximum Strength .15 g/100g; 5 g/100g 41520-0582-19 American 1 tube — — FDA listed —
equate Sensitive 5 g/100g; .15 g/100g 49035-0257-29 Wal-Mart 1 tube — — FDA listed —
Opalescence Whitening Sensitivity Relief 1.1 mg/g; 50 mg/g 51206-0315-01 Ultradent 1 tube — — FDA listed —
CVS Enamel Guard .15 g/100g; 5 g/100g 51316-0128-89 CVS 1 tube — — FDA listed —
Freshmint Sensitive 2.4 mg/g; 50 mg/g 51824-0053-02 New 1 tube — — FDA listed —
DG health Sensitive Maximum Strength .24 g/100g; 5 g/100g 55910-0360-39 Dolgencorp, 1 tube — — FDA listed —
Rexall Sensitive Extra Whitening 5 g/100g; .24 g/100g 55910-0817-01 Old 1 tube — — FDA listed —
Rexall Sensitive Freshmint 5 g/100g; .24 g/100g 55910-0819-01 Old 1 tube — — FDA listed —
Sensitive Extra Whitening .15 g/100g; 5 g/100g 56062-0413-33 Publix 1 tube — — FDA listed —
CVS Extra Whitening .15 g/100g; 5 g/100g 59779-0122-29 CVS 1 tube — — Discontinued —
MIPaste One 5 g/100g; .24 g/100g 61596-0400-10 GC 1 tube — — FDA listed —
Natural White Sensitive Enamel Guard Alpine Mint .15 g/100g; 5 g/100g 62721-0002-01 Lornamead 1 tube — — FDA listed —
Lornamead Natural White .15 g/100g; 5 g/100g 62721-0470-07 Lornamead 1 tube — — FDA listed —
Made by Dentists Enamel Rebuilding Professional 50 mg/g; 1.5 mg/gthis 62776-0003-01 Fulijaya 1 tube — — FDA listed —
Made by Dentists Sensitive and Whitening Professional 50 mg/g; 1.5 mg/g 62776-0004-01 Fulijaya 1 tube — — FDA listed —
Quality Choice Natural White .15 g/100g; 5 g/100g 63868-0172-23 CHAIN 1 tube — — Discontinued —
Colgate Optic White Relief 50 mg/g; 1.5 mg/g 65954-0834-59 Mission 1 tube — — FDA listed —
evo SENSITIVE ANTI-CAVITY FLUORIDE SWEET MINT 5 g/100g; .24 g/100g 70108-0254-01 Ashtel 1 tube — — FDA listed —
dentalux SENSITIVE ANTI-CAVITY FLUORIDE 5 g/100g; .24 g/100g 71141-0187-10 Lidl 1 tube — — FDA listed —
Trader Joes 2.4 mg/g; 50 mg/g 71270-0110-06 TRADER 170 g — — FDA listed —
Wintergreen Peppermint 50 mg/g; 1.5 mg/g 72164-0005-00 Twice 96 g — — FDA listed —
Made By Dentists, Inc. Rebuilding 5 g/100g; .24 g/100g 75065-0019-06 Made 1 tube — — Discontinued —
Made by Dentists Enamel Rebuilding Fresh Mint 50 mg/g; 1.5 mg/g 75065-0028-06 MADE 1 tube — — FDA listed —
Made by Dentists Sensitive and Whitening Fresh Mint 50 mg/g; 1.5 mg/g 75065-0029-06 MADE 1 tube — — FDA listed —
Freshen Up 5 g/100g; 24 mg/100g 77782-0002-13 MKJ 113 g — — FDA listed —
Sensitive Mint Tooth-paste 50 mg/g; 2.43 mg/g 79481-0009-01 Meijer, 1 tube — — FDA listed —
meijer Sensitive EXTRA WHITENING 5 g/100g; .24 g/100g 79481-0038-01 Meijer, 1 tube — — FDA listed —
meijer Sensitive FRESH MINT 5 g/100g; .24 g/100g 79481-0039-01 Meijer, 1 tube — — FDA listed —
Ollie Fresh Mint 2.4 mg/g; 50 mg/g 87493-0000-01 Brio 1 tube — — FDA listed —
Sensodyne Pronamel Clinical Enamel Strength Fresh Breath 50 mg/g; 1.5 mg/g 00135-7753-01 Haleon 1 tube — — FDA listed —
Sensodyne Cavity and Sensitivity 50 mg/g; 1.5 mg/g 00135-4032-01 Haleon 1 tube — — FDA listed —
Made by Dentists Enamel 10 Fluoride Anticavity 50 mg/g; 1.5 mg/g 75065-0033-06 Made 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

🏛️
2024
On the market since
Jan 2024
📍
2026
Currently FDA-listed
2 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

LabelerFulijaya Manufacturing Sdn. Bhd
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code62776
First marketedJan 2024
Product typeHuman Otc Drug
Portfolio7 products on file

More NDCs from Fulijaya Manufacturing Sdn. Bhd labeler code 62776

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 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 21 words ▾

Use: Aids in the prevention of cavities. Helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.

⏱️ Dosage and Administration 67 words ▾

Directions: Adults and children 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly, for at least 1 minute twice a day, (morning and evening) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Children under 12 years of age: Consult a dentist or doctor.

⚠️ Warnings 72 words ▾

Warnings: Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or doctor. Keep out of reach of children under 6 years of age. If more than used for brushing is accidentlly swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 15 words ▾

Active ingredient: Potassium Nitrate 5.0% Sodium Fluoride 0.24% (0.15% w/v fluoride ion) Purpose Antisensitivity Anticavity

🧪 Inactive Ingredients 24 words ▾

Inactive ingredients: Cellulose Gum, Cocamidopropyl Betaine, Flavor, Hydrated Silica, Hydroxyapatite, Pentasodium Triphosphate, Potassium Sorbate, Sodium Bicarbonate, Sodium Saccharin, Sorbitol, Titanium Dioxide, Water (Aqua), Xylitol

🎯 Purpose 3 words ▾

Purpose Antisensitivity Anticavity

📄 Keep Out of Reach of Children 31 words ▾

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentlly swallowed, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 7 words ▾

Questions or comments? + 1 (646) 980-6461

📄 Package Label / Principal Display Panel 3 words ▾

Label Labell.jpg Label2.jpg

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 POTASSIUM NITRATE, SODIUM FLUORIDE — the ingredient across all brands.

Top reported reactions

Drug Effective For Unapproved Indication59
Hyperaesthesia Teeth56
Oral Discomfort48
Drug Effect Less Than Expected42
Therapeutic Product Effect Incomplete42
Condition Aggravated36
Oral Mucosal Exfoliation22

Age at onset

Adolescent1
Adult6
Elderly2

Reporter sex

639 reports
Male · 24%
Female · 76%

Serious outcomes

Hospitalization12
Disabling4
Life-threatening2
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 282 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 Fulijaya Manufacturing Sdn. Bhd. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Fulijaya Manufacturing Sdn. Bhd 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.
← 62776-0002-01 · Fulijaya 62776-0004-01 · Fulijaya →
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.