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Sensitivity Relief Fluoride Free Potassium Nitrate 50 mg/g Paste, Dentifrice — NDC 63404-2105-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Sensitivity Relief Fluoride Free Potassium Nitrate 50 mg/g Paste, Dentifrice — NDC 63404-2105-1 (Billing 63404-2105-01)

by Health and Natural Beauty USA Corp · 1 TUBE in 1 CARTON / 100 g in 1 TUBE

This is a package of Sensitivity Relief Fluoride Free Potassium Nitrate 50 mg/g Paste, Dentifrice from Health and Natural Beauty USA Corp, marketed since Jan 2018 and currently FDA-listed. It is this product's only package size.

NDC 63404-2105-01
🏷️ FDA NDC (as labeled) 63404-2105-1 billing pads the package 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) 63404-2105-1
Product NDC 63404-2105
11-digit billing NDC 63404210501
RxCUI 312544
UNII RU45X2JN0Z
UPC 0363404000077
Application # M022
SPL Set ID c23b2a83-ebc3-4bcf-a216-7693944dcfa0
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-01-01
Route DENTAL
Dosage form PASTE, DENTIFRICE
Substance POTASSIUM NITRATE
Quick answers
  • RxCUI (RxNorm): 312544
Why two NDCs? The FDA registers this code as 63404-2105-1 — a 5-4-1 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 package segment → 63404-2105-01. 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 a toothpaste marketed without fluoride that contains potassium nitrate as its active ingredient. Potassium nitrate is commonly used in sensitivity relief toothpastes to help reduce tooth discomfort associated with exposed dentin. The product is formulated as an OTC monograph drug, meaning it is marketed under FDA's established rules for over-the-counter oral care products rather than through an individual product application. It is applied topically to the teeth during normal brushing.

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
63404-2105-01 You're viewing this Main listing 1 TUBE in 1 CARTON / 100 g in 1 TUBE 2018-01-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dr. Sheffield Sensitive Care 50 mg/g 11527-0420-45 Sheffield 1 tube — — FDA listed —
Attitude Adult Fluoride-free - Sensitive - Spearmint 5 g/100g 61649-0743-01 9055-7588 120 g — — FDA listed —
SprinJene Natural Sensitivity and Gum 50 mg/g 63404-1984-01 Health 1 tube — — FDA listed —
Sensitivity Relief Fluoride Free 50 mg/gthis 63404-2105-01 Health 1 tube — — FDA listed —
Boka Sensitive 5 g/100g 87161-0444-02 Karaka 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

🏛️
2018
On the market since
Jan 2018
📍
2026
Currently FDA-listed
8 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.

What it looks like

Color White
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.

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

LabelerHealth and Natural Beauty USA Corp
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code63404
First marketedJan 2018
Product typeHuman Otc Drug
Portfolio10 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 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 16 words ▾

Uses Helps reduce painful sensitivity of the teeth to cold, heat, acids, and sweets, or contact.

⏱️ Dosage and Administration 66 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 47 words ▾

Warnings Keep out of reach of children. 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.

🧪 Active Ingredient 5 words ▾

Active ingredient Potassium Nitrate 5%

🧪 Inactive Ingredients 39 words ▾

Inactive Ingredients Water, Glycerin, Xylitol, Hydrated Silica, Calcium Carbonate, Zemea from Non-GMO Corn (1,3-Propanediol), Natural Peppermint Oil, Xanthan Gum, Cocamidopropyl Hydroxysultaine, Zinc Citrate, Zinc Oxide, Black Seed Oil (Nigella Sativa), Stevia Rebaudiana Extract, Sodium Lauryl Sulfoacetate (LAL), Acacia Gum

🎯 Purpose 2 words ▾

Purpose Antihypersensitivity

📄 Do Not Use 16 words ▾

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

📄 Ask a Doctor Before Use If 24 words ▾

Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens.

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Questions or Comments 6 words ▾

Questions or comments? Call 1-844-346-2872 www.sprinjene.com

📄 Package Label / Principal Display Panel 82 words ▾

PRINCIPAL DISPLAY PANEL - 100 g Tube Carton SprinJene ® +Sensitivity Natural Relief FLUORIDE FREE TOOTHPASTE with BLACK SEED OIL (Nigella sativa) & Zinc HELPS RELIEVE TEETH SENSITIVITY | FRESHENS BREATH HELPS DRY MOUTH | CLEANS TEETH NET WT

3.5OZ (100 g) Made in USA To accommodate the needs of various lifestyles. USDA CERTIFIED BIOBASED PRODUCT PRODUCT 100% USDA BIOPREFERRED CERTIFIED VEGAN VEGAN.ORG VEGAN GLUTEN-FREE ICS CERTIFIED GLUTEN FREE KOSHER CRUELTY FREE Certified PRINCIPAL DISPLAY PANEL - 100 g Tube Carton

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 Sensitivity Relief Fluoride Free (this brand).

Top reported reactions

Activated Partial Thromboplastin Time Prolonged2
Alopecia2
Anaphylactic Reaction2
Constipation2
Cough2
Diarrhoea2
Drug Interaction2

Age at onset

Adult3
Elderly1

Reporter sex

22 reports
Male · 50%
Female · 50%

Serious outcomes

Hospitalization5
Life-threatening3
Disabling3
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 5 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 ✓ 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, 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 Health and Natural Beauty USA Corp. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Health and Natural Beauty USA Corp 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.
← 63404-1984-01 · Health 63404-2210-01 · Health →
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.