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BIO SPECTRA ATTITUDE Sodium fluoride and Potassium nitrate .243 g/100g; 5 g/100g Paste, Dentifrice, 120 g — NDC 61649-0733-01 package photo

BIO SPECTRA ATTITUDE Sodium fluoride and Potassium nitrate .243 g/100g; 5 g/100g Paste, Dentifrice, 120 g

by 9055-7588 Quebec Inc. DBA Attitude · 120 g in 1 TUBE (61649-733-01)
NDC 61649-0733-01
🏷️ FDA NDC (as labeled) 61649-733-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 27, 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) 61649-733-01
Product NDC 61649-733
11-digit billing NDC 61649073301
RxCUI 1038800
UNII 8ZYQ1474W7, RU45X2JN0Z
Application # M022
SPL Set ID 42b79ec5-f37f-4dc9-9631-c8b1c153fe88
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-04-26
Route DENTAL
Dosage form PASTE, DENTIFRICE
Substance SODIUM FLUORIDE; POTASSIUM NITRATE
Why two NDCs? The FDA registers this code as 61649-733-01 — 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 → 61649-0733-01. 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.

🏭 Manufacturer & labeler

Labeler9055-7588 Quebec Inc. DBA Attitude
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code61649
First marketedApr 2024
Product typeHuman Otc Drug
Portfolio33 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 and potassium nitrate toothpaste sold as an over-the-counter monograph drug product. Sodium fluoride is commonly used in dental care to help strengthen tooth enamel and reduce cavity risk. Potassium nitrate is typically included in toothpastes to help reduce tooth sensitivity. The product is applied to teeth during brushing as part of regular oral hygiene.

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
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 XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII 66J7636Z2I
    A plant extract from papaya leaves used in formulations as a natural flavoring agent and to support product stability. It may also help improve the taste and appeal of the medicine.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII W2ZU1RY8B0
    A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability during storage.
  • 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 LAV5U5022Y
    Methyl salicylate is a naturally derived liquid compound commonly found in wintergreen plants. In medicines, it's used as a flavoring agent and penetrating solvent to help distribute active ingredients evenly throughout topical products.
  • UNII 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII B3FUD0528F
    Rebaudioside A is a naturally derived sweetener extracted from stevia leaves. It sweetens the medicine without adding calories and helps mask bitter tastes to improve how the medication goes down.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • 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 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.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesAqua / Water / Eau, Sorbitol, Hydrated Silica, Glycerin, Sodium Lauryl Sulfate, Gaultheria Procumbens (Wintergreen) Leaf Oil, Citric Acid, Xanthan Gum, Rebaudioside A, Sodium Benzoate, Potassium Sorbate, Carica Papaya (Papaya) Leaf Extract, Camellia Sinensis (Tea) Leaf Extract.

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.
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
Rite Aid Enamel Guard .15 g/100g; 5 g/100g 11822-6020-09 Rite 1 tube — — FDA listed —
Crest Premium Plus Sensitivity Active Foam 50 mg/g; 1.4 mg/g 37000-0995-52 The 1 tube — — FDA listed —
Sensitive Tooth Polish .26244 g/108g; 5.4 g/108g 54473-0302-04 Melaleuca, 108 g — — FDA listed —
CVS Pharmacy Enamel Guard .15 g/100g; 5 g/100g 59779-0815-49 CVS 1 tube — — FDA listed —
Bio Spectra Attitude .243 g/100g; 5 g/100gthis 61649-0733-01 9055-7588 120 g — — FDA listed —
Sensitive Whitening Tooth-paste 50 mg/g; 2.43 mg/g 79481-0008-01 Meijer, 1 tube — — FDA listed —
Crest Pro-Health Sensitivity Whitening Plus Scope 50 mg/g; 1.4 mg/g 84126-0622-06 The 2 tubes — — FDA listed —
Crest Pro-Health Sensitivity Relief 50 mg/g; 1.4 mg/g 84126-0639-05 The 2 tubes — — FDA listed —
Anticavity and sensitive peppermint .243 g/100g; 5 g/100g 87649-0907-01 Dyson 94.5 g — — 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
Apr 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.

🔬 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 BIO SPECTRA ATTITUDE (this brand).

Top reported reactions

Pyrexia477
Macular Degeneration460
Nausea450
Pain440
Weight Decreased379
Headache329
Infusion Related Reaction307

Reporter sex

3,003 reports
Male · 36%
Female · 64%
Unknown · 0%

Serious outcomes

Death550
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 409 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
61649-0733-01 You're viewing this 120 g in 1 TUBE (61649-733-01) 2021-05-15 Active

🧭 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 61649-733-01, 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: 61649-0733-01, written without dashes as 61649073301. 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 61649-0733-01, the first segment (61649) is the labeler code FDA assigned to 9055-7588 Quebec Inc. DBA Attitude; the middle segment (0733) 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 9055-7588 Quebec Inc. DBA Attitude. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
9055-7588 Quebec Inc. DBA Attitude 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 42 words ▾

Uses Builds protection against sensitivity of the teeth. Shields and soothes dental nerves for lasting sensitivity relief when used regularly. Prevents, fights and protects against cavities. Effective fluoride protection. Protects teeth from acid erosion. Penetrates tooth enamel to help rebuild weak spots.

⏱️ Dosage and Administration 61 words ▾

Directions Do not swallow. Should be used as part of an oral health program that includes regular flossing and dental check-ups. Brush teeth thoroughly for at least 1 minute twice a day, preferably after each meal, or as directed by a dentist or health care professional. Not recommended for children under 12 years of age. Store at room temperature (15-30 °C).

⚠️ Warnings 40 words ▾

Warnings Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away. Sensitive teeth may indicate a serious problem. Stop use and consult a health care professional if symptoms persist or worsen.

🧪 Active Ingredient 13 words ▾

Active ingredients Purpose Sodium fluoride (0.243% w/w) Anti-cavity Potassium nitrate (5% w/w) Anti-hypersensitivity

🧪 Inactive Ingredients 39 words ▾

Non-medicinal ingredients Aqua / Water / Eau, Sorbitol, Hydrated Silica, Glycerin, Sodium Lauryl Sulfate, Gaultheria Procumbens (Wintergreen) Leaf Oil, Citric Acid, Xanthan Gum, Rebaudioside A, Sodium Benzoate, Potassium Sorbate, Carica Papaya (Papaya) Leaf Extract, Camellia Sinensis (Tea) Leaf Extract.

🎯 Purpose 13 words ▾

Active ingredients Purpose Sodium fluoride (0.243% w/w) Anti-cavity Potassium nitrate (5% w/w) Anti-hypersensitivity

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 61649-0732-01 · 9055-7588 61649-0734-01 · 9055-7588 →
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.