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NATEAN Clean and Whiten sodium fluoride 1.5 mg/g Paste — NDC 00135-1200-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

NATEAN Clean and Whiten sodium fluoride 1.5 mg/g Paste — NDC 0135-1200-03 (Billing 00135-1200-03)

by Haleon US Holdings LLC · 1 TUBE in 1 CARTON / 133 g in 1 TUBE

This is a package of NATEAN Clean and Whiten sodium fluoride 1.5 mg/g Paste from Haleon US Holdings LLC, marketed since Jan 2022 and currently FDA-listed. It is this product's only package size.

NDC 00135-1200-03
🏷️ FDA NDC (as labeled) 0135-1200-03 billing pads the labeler 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) 0135-1200-03
Product NDC 0135-1200
11-digit billing NDC 00135120003
RxCUI 1044547
UNII 8ZYQ1474W7
Application # M022
SPL Set ID 71b95962-2693-49f5-94d2-f2a035b5e0c8
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-01-03
Route ORAL
Dosage form PASTE
Substance SODIUM FLUORIDE
Quick answers
  • RxCUI (RxNorm): 1044547
Why two NDCs? The FDA registers this code as 0135-1200-03 — 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 → 00135-1200-03. 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.

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.

Clinical

📖 About the active ingredient: Sodium Fluoride MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usually is prescribed for children and adults whose homes have water that is not fluoridated (already has fluoride added). This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗
🧪 What is this product?

NATEAN Clean and Whiten is a toothpaste containing sodium fluoride, an ingredient commonly used in oral care products to help strengthen tooth enamel and reduce cavity formation. This over-the-counter monograph product is marketed under FDA's established rules for toothpastes and is applied directly to the teeth during brushing. Sodium fluoride in toothpaste typically functions as a topical fluoride agent to support dental health as part of a regular oral hygiene routine.

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
00135-1200-03 You're viewing this Main listing 1 TUBE in 1 CARTON / 133 g in 1 TUBE 2022-01-03 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Aquafresh Extreme Clean Whitening Action 1.13 mg/g 00135-0234-06 Haleon 1 tube — — FDA listed —
BIOTENE Fresh Mint Original 1.5 mg/g 00135-0557-01 Haleon 1 tube — — FDA listed —
Aquafresh Cavity Protection 1.15 mg/g 00135-0590-01 Haleon 1 tube — — FDA listed —
Aquafresh Extra Fresh Plus Whitening 1.15 mg/g 00135-0591-01 Haleon 1 tube — — FDA listed —
Aquafresh Extreme Clean Pure Breath Action 1.15 mg/g 00135-0604-01 Haleon 1 tube — — FDA listed —
NATEAN Clean and Whiten 1.5 mg/gthis 00135-1200-03 Haleon 1 tube — — FDA listed —
Opalescence Whitening 1.1 mg/g 51206-0302-06 Ultradent 1 tube — — FDA listed —
Opal by Opalescence Original 1.1 mg/g 51206-0312-02 Ultradent 1 tube — — FDA listed —
MySweetSmile Toothpaste. .25 g/100g 83778-0090-02 Jiangxi 60 g — — FDA listed —
MySweetSmile Mango Toothpaste. .25 g/100g 83778-0091-03 Jiangxi 60 g — — FDA listed —
MySweetSmile Strawberry Toothpaste. .25 g/100g 83778-0092-04 Jiangxi 60 g — — FDA listed —
Crest 3D White Stain Eraser Daily Stain Prevention Polishing Mint 1.5 mg/g 84126-0636-38 The 1 tube — — FDA listed —
Handy Solutions Crest Complete MULTI-BENEFIT WHITENING plus Scope 1.5 mg/g 67751-0095-01 Navajo 1 tube — — FDA listed —
BIOTENE Gentle Mint 1.5 mg/g 00135-0558-01 Haleon 1 tube — — FDA listed —
Crest 3D White Vibrant Mint 1.5 mg/g 69423-0774-23 The 1 tube — — FDA listed —
Crest 3D White Stain Eraser Daily Stain Prevention Icy Clean Mint 1.5 mg/g 84126-0635-02 The 2 tubes — — FDA listed —
Crest 3D White Stain Eraser Icy Clean Mint 1.5 mg/g 69423-0773-31 The 1 tube — — FDA listed —
Crest 3D White Stain Eraser Polishing Mint 1.5 mg/g 69423-0958-23 The 1 tube — — Discontinued —
Crest 3D White Stain Eraser Fresh Mint 1.5 mg/g 69423-0891-23 The 1 tube — — FDA listed —
Crest 3D White Stain Eraser Daily Stain Prevention Icy Clean Mint 1.5 mg/g 84126-0637-23 The 1 tube — — FDA listed —
Crest 3D White Stain Eraser Luxe Mint 1.5 mg/g 84126-0645-23 The 1 tube — — FDA listed —
Crest 3D White Stain Eraser Mint Splash 1.5 mg/g 84126-0646-23 The 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

🏛️
2022
On the market since
Jan 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.

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 U182GP2CF3
    Bromelain is an enzyme derived from pineapple plants that breaks down proteins. In medications, it acts as a disintegrant, helping tablets or capsules break apart and release their active ingredients more quickly in the digestive system.
  • 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 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII A236A06Y32
    Papain is an enzyme derived from papaya fruit. In medicines, it works as a proteolytic agent to help break down proteins and improve the dissolving or absorption of active ingredients in the formulation.
  • 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 BMT4RCZ3HG
    Sodium cocoyl glutamate is a mild cleanser derived from coconut oil and amino acids. It's used in medicines as a surfactant to help dissolve and distribute active ingredients evenly throughout the formulation.
  • 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.

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

The official label also stateswater, hydrated silica, sorbitol, glycerin, cocamidopropyl betaine, sodium cocoyl glutamate, flavor, xanthan gum, rebaudioside A, maltodextrin, bromelain, papain

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.

Manufacturer & labeler

LabelerHaleon US Holdings LLC
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code00135
First marketedJan 2022
Product typeHuman Otc Drug
Portfolio405 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 8 words ▾

Use aids in the prevention of dental cavities.

⏱️ Dosage and Administration 56 words ▾

Directions adults and children 12 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, and not more than 3 times a day, or as recommended by a dentist or doctor. Minimize swallowing. Spit out after brushing. Children under 12 years of age: Consult a dentist or doctor

⚠️ Warnings 36 words ▾

Warnings When using this product, if irritation occurs discontinue 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.

📦 Storage and Handling 8 words ▾

Other information do not store above 25°C (77F°)

🧪 Active Ingredient 9 words ▾

Active ingredient Sodium fluoride 0.25% (0.15% w/v fluoride ion)

🧪 Inactive Ingredients 20 words ▾

Inactive ingredients water, hydrated silica, sorbitol, glycerin, cocamidopropyl betaine, sodium cocoyl glutamate, flavor, xanthan gum, rebaudioside A, maltodextrin, bromelain, papain

🎯 Purpose 2 words ▾

Purpose Anticavity

📄 Keep Out of Reach of Children 26 words ▾

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.

📄 Questions or Comments 4 words ▾

Questions or comments? 1-800-733-5879

📄 Package Label / Principal Display Panel 44 words ▾

Principal Display Panel NDC 0135-1200-03 Natean FLUORIDE TOOTHPASTE NATURAL FLAVORS AND SWEETENERS NON-GMO / GLUTEN-FREE NO ARTIFICIAL PRESERVATIVES, COLORS, DYES NO SLS/TRICLOSAN VEGAN-FRIENDLY* INFUSED WITH BOTANICALS FLUORIDE CLEAN + WHITEN CLEAN MINT NET WT

4.7 OZ (133g) 60000000133573 Front Carton Natean Clean+Whiten

4.7 OZ

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 NATEAN Clean and Whiten (this brand).

Top reported reactions

Pyrexia172
Weight Increased162
Nausea160
Vomiting159
Fatigue158
Pain158
Nasopharyngitis155

Reporter sex

1,067 reports

Serious outcomes

Death347
Life-threatening84
Disabling79
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 213 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) ✓ 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 Haleon US Holdings LLC. Listing status can change — the directory data on this page refreshes weekly.
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.
← 00135-1002-01 · Haleon 00135-1250-01 · 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.