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Sensodyne Pronamel Gentle Whitening Advanced potassium nitrate and sodium fluoride 50 mg/g; 1.15 mg/g Paste — NDC 00135-0580-02 package photo

Sensodyne Pronamel Gentle Whitening Advanced potassium nitrate and sodium fluoride 50 mg/g; 1.15 mg/g Paste

by Haleon US Holdings LLC · 4 TUBE in 1 CARTON (0135-0580-02) / 184 g in 1 TUBE
NDC 00135-0580-02
🏷️ FDA NDC (as labeled) 0135-0580-02 billing pads the labeler segment with a zero
This package
Contains184 g in 1 tube Pack sizes2 compare ↓
Also comes in: 184 g 00135-0580-01
OTC On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 0135-0580-02
Product NDC 0135-0580
11-digit billing NDC 00135058002
RxCUI 1086243
UNII RU45X2JN0Z, 8ZYQ1474W7
Application # M022
SPL Set ID 94e07979-943b-45bb-8e2b-90d686f3692e
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-03-15
Route DENTAL
Dosage form PASTE
Substance POTASSIUM NITRATE; SODIUM FLUORIDE
Why two NDCs? The FDA registers this code as 0135-0580-02 — a 4-4-2 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 labeler segment → 00135-0580-02. 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

LabelerHaleon US Holdings LLC
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code00135
First marketedMar 2021
Product typeHuman Otc Drug
Portfolio404 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?

Sensodyne Pronamel Gentle Whitening is a toothpaste containing potassium nitrate and sodium fluoride. Sodium fluoride is commonly used in toothpastes to help strengthen tooth enamel and reduce cavity formation. Potassium nitrate is typically included in dental products to help reduce tooth sensitivity. This is an over-the-counter monograph drug, meaning it is marketed under FDA's established rules for toothpaste products rather than through an individual product application.

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
FlavorMint
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 5OCF3O11KX
    A plant-derived surfactant made from coconut oil. It helps mix oil and water ingredients together in the formulation and can improve how the medicine spreads or feels on the skin.
  • 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 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 B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • 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 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 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.
  • 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.

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

The official label also stateswater, hydrated silica, sorbitol, glycerin, PEG-8, cocamidopropyl betaine, flavor, xanthan gum, titanium dioxide, sodium saccharin, sodium hydroxide

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: 184 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
SENSODYNE PRONAMEL mineral BOOST refreshing peppermint 50 mg/g; 1.15 mg/g 00135-0450-01 Haleon 1 tube — — FDA listed —
SENSODYNE PRONAMEL Daily Protection 50 mg/g; 1.15 mg/g 00135-0460-01 Haleon 1 tube — — FDA listed —
SENSODYNE Advanced Whitening 50 mg/g; 1.15 mg/g 00135-0479-01 Haleon 1 tube — — FDA listed —
SENSODYNE PRONAMEL mineral BOOST whitening action 50 mg/g; 1.15 mg/g 00135-0480-01 Haleon 1 tube — — FDA listed —
SENSODYNE PRONAMEL Intensive Enamel Repair Whitening 50 mg/g; 1.15 mg/g 00135-0481-01 Haleon 1 tube — — FDA listed —
SENSODYNE PRONAMEL Gentle Whitening 50 mg/g; 1.15 mg/g 00135-0484-01 Haleon 1 tube — — FDA listed —
SENSODYNE PRONAMEL Intensive Enamel Repair Extra Fresh 50 mg/g; 1.15 mg/g 00135-0486-01 Haleon 1 tube — — FDA listed —
SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint 50 mg/g; 1.15 mg/g 00135-0492-01 Haleon 1 tube — — FDA listed —
SENSODYNE PRONAMEL Fresh Breath 50 mg/g; 1.15 mg/g 00135-0520-01 Haleon 1 tube — — FDA listed —
Sensodyne Fresh Mint 50 mg/g; 1.15 mg/g 00135-0529-01 Haleon 1 tube — — FDA listed —
SENSODYNE PRONAMEL Multi Action 50 mg/g; 1.15 mg/g 00135-0568-04 Haleon 1 tube — — FDA listed —
Sensodyne Pronamel Gentle Whitening Advanced 50 mg/g; 1.15 mg/gthis 00135-0580-02 Haleon 4 tubes — — FDA listed —
sensodyne 50 mg/g; 1.15 mg/g 00135-0593-01 Haleon 1 tube — — FDA listed —
Sensodyne Pronamel Strong and Bright Enamel Mint 50 mg/g; 1.15 mg/g 00135-0602-01 Haleon 1 tube — — FDA listed —
Sensodyne Pronamel Strong and Bright Enamel Extra Fresh 50 mg/g; 1.15 mg/g 00135-0603-01 Haleon 1 tube — — FDA listed —
Sensodyne Pronamel Gentle Whitening Fresh Mint 50 mg/g; 1.15 mg/g 00135-0644-01 Haleon 1 tube — — FDA listed —
SENSODYNE PRONAMEL Active Shield Fresh Mint 50 mg/g; 1.15 mg/g 00135-0700-01 Haleon 1 tube — — FDA listed —
SENSODYNE PRONAMEL Active Shield Cool Mint 50 mg/g; 1.15 mg/g 00135-0701-01 Haleon 1 tube — — FDA listed —
Sensodyne Clinical White Stain Protector 50 mg/g; 2.5 mg/g 00135-0702-01 Haleon 1 tube — — FDA listed —
Sensodyne Clinical White Enamel Strengthening 50 mg/g; 2.5 mg/g 00135-0703-01 Haleon 1 tube — — FDA listed —
Sensodyne Pronamel Clinical Enamel Strength Deep Clean 50 mg/g; 1.15 mg/g 00135-0810-01 Haleon 23 g — — FDA listed —
Sensodyne Pronamel Clinical Enamel Strength Whitening Action 50 mg/g; 1.15 mg/g 00135-0811-02 Haleon 1 tube — — FDA listed —
NATEAN Clean plus Sensitivity Relief 50 mg/g; 1.5 mg/g 00135-1250-01 Haleon 1 tube — — FDA listed —
Sensodyne Cavity and Sensitivity 50 mg/g; 1.5 mg/g 00135-4032-01 Haleon 1 tube — — FDA listed —
Sensodyne Nourish Gently Soothing 50 mg/g; 1.15 mg/g 00135-5026-01 Haleon 1 tube — — FDA listed —
Sensodyne Nourish Healthy White 50 mg/g; 1.15 mg/g 00135-5027-01 Haleon 1 tube — — FDA listed —
Sensodyne Natural white 50 mg/g; 1.15 mg/g 00135-5028-01 Haleon 1 tube — — FDA listed —
SENSODYNE Advanced Whitening Plus 50 mg/g; 1.11 mg/g 00135-5029-01 Haleon 4 tubes — — FDA listed —
Sensodyne Pronamel Gentle Whitening Advanced Plus 50 mg/g; 1.11 mg/g 00135-5030-01 Haleon 4 tubes — — FDA listed —
Sensodyne Clinical White Intensive Clean 50 mg/g; 1.1 mg/g 00135-5468-01 Haleon 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 —
Walgreens Sensitive Enamel Repair .15 g/100g; 5 g/100g 00363-0593-10 Walgreens 1 tube — — FDA listed —
Pronamel Repair Whitening .15 g/100g; 5 g/100g 11822-6310-01 Rite 1 tube — — FDA listed —
Intensive Enamel Repair Whitening TP 5 g/100g; .15 g/100g 36800-0362-10 Topco 1 tube — — FDA listed —
Opalescence Sensitivity Relief Whitening 50 mg/g; 1.1 mg/g 51206-0308-01 Ultradent 1 tube — — FDA listed —
Opal by Opalescence Sensitivity 50 mg/g; 1.1 mg/g 51206-0311-01 Ultradent 1 tube — — FDA listed —
CVS Health Sensitive Enamel Repair .15 g/100g; 5 g/100g 51316-0169-10 CVS 1 tube — — FDA listed —
CVS Health Clinical White Stain Protector .15 g/100g; 5 g/100g 51316-0205-10 CVS 1 tube — — FDA listed —
Pronamel Repair Whitening 5 g/100g; .15 g/100g 56062-0514-44 Publix 1 tube — — FDA listed —
Sensodyne Extra Whitening Cool Mint 50 mg/g; 1.15 mg/g 00135-0643-01 Haleon 1 tube — — FDA listed —
Sensodyne True white 50 mg/g; 1.15 mg/g 00135-0579-01 Haleon 1 tube — — FDA listed —
Sensodyne True white 50 mg/g; 1.15 mg/g 00135-0581-01 Haleon 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

🏛️
2021
On the market since
Mar 2021
📍
2026
Currently FDA-listed
5 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 Sensodyne Pronamel Gentle Whitening Advanced (this brand).

Top reported reactions

Oral Discomfort9
Hyperaesthesia Teeth7
Burn Oral Cavity6
Product Complaint5
Toothache5
Choking4
Drug Effective For Unapproved Indication4

Age at onset

Elderly1

Reporter sex

72 reports
Male · 30%
Female · 70%
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 26 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
00135-0580-01 1 TUBE in 1 CARTON (0135-0580-01) / 184 g in 1 TUBE 2021-03-15 Active
00135-0580-02 You're viewing this 4 TUBE in 1 CARTON (0135-0580-02) / 184 g in 1 TUBE 2023-07-01 Active

Pack size FAQ

What quantity is in NDC 00135-0580-02?
NDC 00135-0580-02 is listed by the FDA — 4 tube in 1 carton / 184 g in 1 tube.
What NDC number is used to bill for this package of Sensodyne Pronamel Gentle Whitening Advanced potassium nitrate and sodium fluoride 50 mg/g; 1.15 mg/g Paste?
Bill NDC 00135-0580-02 — the 11-digit billing format is 00135058002. 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 0135-0580-02, 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: 00135-0580-02, written without dashes as 00135058002. 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 00135-0580-02, the first segment (00135) is the labeler code FDA assigned to Haleon US Holdings LLC; the middle segment (0580) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 Haleon US Holdings LLC. 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 (00135-0580-01). 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?
Haleon US Holdings LLC 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 26 words ▾

Uses • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. • aids in the prevention of dental cavities.

⏱️ Dosage and Administration 85 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), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing. • children under 12 years of age: Consult a dentist or doctor.

⚠️ Warnings 64 words ▾

Warnings Stop use and ask a dentist if • the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. • pain/sensitivity still persists after 4 weeks of use. Keep out of reach of children If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 12 words ▾

Active ingredients Potassium nitrate 5% Sodium fluoride 0.25% (0.15% w/v fluoride ion)

🧪 Inactive Ingredients 19 words ▾

Inactive ingredients water, hydrated silica, sorbitol, glycerin, PEG-8, cocamidopropyl betaine, flavor, xanthan gum, titanium dioxide, sodium saccharin, sodium hydroxide

🎯 Purpose 3 words ▾

Purposes Antihypersensitivity Anticavity

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00135-0579-01 · Haleon 00135-0581-01 · Haleon →
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.