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Sensodyne Pronamel Kids Berry Twist sodium fluoride 1.1 mg/g Paste, 23 g — NDC 00135-0809-02 package photo

Sensodyne Pronamel Kids Berry Twist sodium fluoride 1.1 mg/g Paste, 23 g

by Haleon US Holdings LLC · 23 g in 1 TUBE (0135-0809-02)
NDC 00135-0809-02
🏷️ FDA NDC (as labeled) 0135-0809-02 billing pads the labeler segment with a zero
This package
Contains23 g Pack sizes3 compare ↓
Also comes in: 113 g 00135-0809-01 2 tubes 00135-0809-03
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) 0135-0809-02
Product NDC 0135-0809
11-digit billing NDC 00135080902
UNII 8ZYQ1474W7
Application # M022
SPL Set ID 69c07c36-b5e0-420b-ab29-7d1091386322
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-01-06
Route DENTAL
Dosage form PASTE
Substance SODIUM FLUORIDE
Why two NDCs? The FDA registers this code as 0135-0809-02 — 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 → 00135-0809-02. 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 marketedJan 2025
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.

🩺 Clinical

🧪 What is this product?

Sensodyne Pronamel Kids Berry Twist is a fluoride toothpaste intended for children's dental use. It contains sodium fluoride, which is commonly included in toothpastes to help strengthen tooth enamel and support cavity prevention. This product is an over-the-counter monograph drug, meaning it is marketed under established FDA guidelines for fluoride toothpaste products rather than as an individually reviewed 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

FlavorStrawberry
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.

💲 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: 113 g 2 tubes
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
Colgate MaxClean with Whitening Smartfoam 1.1 mg/g 35000-0028-60 Colgate-Palmolive 1 tube — — Discontinued —
Colgate MaxFresh Citrus Fresh 1.1 mg/g 35000-0137-48 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Kids Space Jam Mild Bubble Fruit Flavor 1.1 mg/g 35000-0199-44 Colgate-Palmolive 124 g — — FDA listed —
Colgate Sparkling White Cinnamint 1.1 mg/g 35000-0900-60 Colgate-Palmolive 1 tube — — Discontinued —
Colgate Junior Mixed Kids Bubble Fruit Fluoride 1.1 mg/g 35000-0958-46 Colgate-Palmolive 130 g — — Discontinued —
Sensodyne Pronamel Kids Bubble Twist 1.1 mg/g 00135-0808-01 Haleon 1 tube — — FDA listed —
Opalescence Whitening Cool Mint 1.1 mg/g 51206-0314-01 Ultradent 1 tube — — FDA listed —
Colgate Kids Mild Bubble Fruit Flavor 1.1 mg/g 65954-0065-46 Mission 130 g — — FDA listed —
Colgate Junior Bubble Fruit 1.1 mg/g 65954-0327-20 Mission 1 tube — — FDA listed —
Colgate Max Fresh Cool Mint 1.1 mg/g 65954-0564-81 Mission 130 g — — FDA listed —
TP COL OW Purple 1.1 mg/g 65954-0825-58 Mission 1 tube — — FDA listed —
Colgate 2 In 1 Kids Sp Strawberry 1.1 mg/g 65954-0832-46 Mission 130 g — — FDA listed —
Colgate Optic White Relief 1.1 mg/g 35000-0799-59 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Max Fresh Cool Mint 1.1 mg/g 35000-0903-01 Colgate-Palmolive 1 tube — — FDA listed —
Crest Complete Multi-Benefit Plus Scope 1.1 mg/g 37000-0822-04 The 130 g — — FDA listed —
Colgate Junior Kids Batman Mild Bubble Fruit Fluoride 1.1 mg/g 65954-0585-46 Mission 130 g — — FDA listed —
Colgate Cavity Protection 1.1 mg/g 65954-0591-71 Mission 119 g — — FDA listed —
Colgate Ultra White Charcoal 1.1 mg/g 35000-0418-98 Colgate-Palmolive 1 tube — — FDA listed —
Hello Magical Mermaid 1.1 mg/g 35000-0680-10 Colgate-Palmolive 119 g — — FDA listed —
Colgate Kids Mild Bubble Fruit Flavor 1.1 mg/g 35000-0918-46 Colgate-Palmolive 130 g — — FDA listed —
Colgate Cavity Protection 1.1 mg/g 35000-0953-71 Colgate-Palmolive 119 g — — FDA listed —
Colgate Deep Clean Fluoride 1.1 mg/g 35000-0969-58 Colgate-Palmolive 1 tube — — FDA listed —
Colgate MaxFresh Charcoal 1.1 mg/g 35000-0990-34 Colgate-Palmolive 2 tubes — — Discontinued —
Sensodyne Pronamel Kids Berry Twist 1.1 mg/gthis 00135-0809-02 Haleon 23 g — — FDA listed —
Colgate Maximum Cavity Protection Bubble Fruit Flavor 1.1 mg/g 35000-0196-44 Colgate-Palmolive 124 g — — FDA listed —
Colgate MaxFresh Clean Mint 1.1 mg/g 35000-0212-30 Colgate-Palmolive 1 cello — — FDA listed —
Optic White Non-Hp Stain Fighter Clean Mint 1.1 mg/g 35000-0793-38 Colgate-Palmolive 2 tubes — — FDA listed —
Colgate Optic White Purple 1.1 mg/g 35000-0796-59 Colgate-Palmolive 1 tube — — FDA listed —
Colgate 2In1 Icy Blast 1.1 mg/g 35000-0927-81 Colgate-Palmolive 130 g — — FDA listed —
TP OW Stainfighter Clean Mint 1.1 mg/g 35000-0999-34 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Sparkling White Cinnamint 1.1 mg/g 65954-0008-69 Mission 1 tube — — FDA listed —
Colgate Triple Action 1.1 mg/g 65954-0536-30 Mission 3 tubes — — FDA listed —
Colgate Junior Mixed Kids Bubble Fruit Fluoride 1.1 mg/g 65954-0607-46 Mission 1 tube — — FDA listed —
Colgate Max Fresh Clean Mint 1.1 mg/g 65954-0831-58 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Kids Cavity Protection 1.1 mg/g 35000-0015-32 Colgate-Palmolive 90 g — — FDA listed —
Colgate Optic White Non-Hp Stain Fighter Fresh Mint 1.1 mg/g 35000-0797-59 Colgate-Palmolive 1 tube — — Discontinued —
Colgate Optic White Charcoal 1.1 mg/g 35000-0798-59 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Junior Bubble Fruit 1.1 mg/g 35000-0926-20 COLGATE 1 tube — — Discontinued —
Toms Of Maine Whiten Plus Deep Clean Spearmint 1.1 mg/g 51009-0921-40 Tom's 1 tube — — FDA listed —
Colgate Max Fresh Cool Mint 1.1 mg/g 65954-0014-01 Mission 1 tube — — FDA listed —
Colgate Kids Watermelon Flavor 1.1 mg/g 65954-0036-81 Mission 130 g — — Discontinued —
COLGATE MAX WHITE WITH MINI BRIGHT STRIPS Crystal MINT 1.1 mg/g 65954-0041-81 Mission 130 g — — Discontinued —
Colgate Cavity Protection Fresh Mint 1.1 mg/g 65954-0061-69 Mission 113 g — — Discontinued —
Colgate Deep Clean Fluoride 1.1 mg/g 65954-0777-58 Mission 1 tube — — FDA listed —
Colgate Minions Mild Bubble Fruit Fluoride 1.1 mg/g 65954-0779-46 Mission 130 g — — FDA listed —
Colgate Optic White Stain Fighter with Baking Soda 1.1 mg/g 65954-0810-42 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Optic White Charcoal 1.1 mg/g 65954-0835-59 Mission 1 tube — — FDA listed —
Colgate MaxFresh with Mini Breath Clean Mint 1.1 mg/g 35000-0013-34 Colgate-Palmolive 2 tubes — — Discontinued —
Colgate MaxFresh Cool Mint 1.1 mg/g 35000-0211-30 COLGATE 1 cello — — FDA listed —
Colgate Triple Action 1.1 mg/g 35000-0941-46 Colgate-Palmolive 1 tube — — Discontinued —
Colgate 2In1 Whitening Stain Lifters 1.1 mg/g 65954-0038-81 Mission 130 g — — FDA listed —
Colgate Ultra Brite Advanced Whitening All In One Clean Mint 1.1 mg/g 65954-0064-60 Mission 1 tube — — FDA listed —
Colgate Optic White Non-Hp Stain Fighter Clean Mint 1.1 mg/g 65954-0840-38 Mission 2 tubes — — FDA listed —
Colgate MaxFresh with Mini Breath Cool Mint 1.1 mg/g 35000-0014-34 Colgate-Palmolive 2 tubes — — Discontinued —
Colgate Kids Llama Mild Bubble Fruit Flavor 1.1 mg/g 35000-0365-44 Colgate-Palmolive 124 g — — FDA listed —
Colgate MaxFresh Clean Mint 1.1 mg/g 35000-0430-58 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Kids Watermelon Flavor 1.1 mg/g 35000-0905-81 Colgate-Palmolive 130 g — — Discontinued —
Colgate Ultra Brite Advanced Whitening All In One Clean Mint 1.1 mg/g 35000-0917-60 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Optic White Charcoal 1.1 mg/g 35000-0988-71 Colgate-Palmolive 1 tube — — FDA listed —
Toms of Maine Whiten Plus Deep Clean Peppermint 1.1 mg/g 51009-0920-40 Tom's 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 —
Colgate Kids Maximum Cavity Protection 1.1 mg/g 35000-0190-44 Colgate-Palmolive 124 g — — FDA listed —
Colgate MaxFresh Knockout 1.1 mg/g 35000-0214-30 Colgate-Palmolive 1 cello — — FDA listed —
TP COL OW Purple 1.1 mg/g 35000-0419-71 Colgate-Palmolive 1 tube — — FDA listed —
Colgate 2In1 Whitening Stain Lifters 1.1 mg/g 35000-0907-81 Colgate-Palmolive 130 g — — Discontinued —
Colgate Max Fresh Cool Mint 1.1 mg/g 35000-0947-81 Colgate-Palmolive 130 g — — FDA listed —
Colgate Junior Kids Batman Mild Bubble Fruit Fluoride 1.1 mg/g 35000-0950-46 Colgate-Palmolive 130 g — — FDA listed —
Colgate MaxFresh Knockout 1.1 mg/g 35000-0127-60 COLGATE 1 tube — — Discontinued —
Colgate Optic White Stain Fighter With Baking Soda 1.1 mg/g 35000-0809-42 Colgate-Palmolive 1 tube — — FDA listed —
COLGATE MAX WHITE WITH MINI BRIGHT STRIPS Crystal MINT 1.1 mg/g 35000-0908-81 Colgate-Palmolive 130 g — — Discontinued —
Colgate Strawberry Burst 1.1 mg/g 35000-0915-46 Colgate-Palmolive 130 g — — FDA listed —
Colgate Minions Mild Bubble Fruit Fluoride 1.1 mg/g 35000-0971-46 Colgate-Palmolive 130 g — — FDA listed —
Sensodyne Pronamel Kids Bubble Mint 1.1 mg/g 00135-0818-01 Haleon 1 tube — — FDA listed —
Colgate 2In1 Icy Blast 1.1 mg/g 65954-0355-81 Mission 130 g — — FDA listed —
Colgate Optic White Non-Hp Stain Fighter Fresh Mint 1.1 mg/g 65954-0836-59 Mission 1 tube — — FDA listed —
Colgate Optic White Purple 1.1 mg/g 65954-0837-59 Mission 1 tube — — FDA listed —
Colgate Kids Harry Potter 1.1 mg/g 35000-0016-46 Colgate-Palmolive 130 g — — FDA listed —
Colgate MaxFresh Watermelon Blast 1.1 mg/g 35000-0138-48 Colgate-Palmolive 1 tube — — FDA listed —
Colgate MaxFresh Charcoal 1.1 mg/g 35000-0213-95 Colgate-Palmolive 1 tube — — FDA listed —
Hello Unicorn Sparkle 1.1 mg/g 35000-0686-10 Colgate-Palmolive 1 tube — — FDA listed —
Hello Penguin Chill 1.1 mg/g 35000-0693-12 Colgate-Palmolive 1 tube — — FDA listed —
Toms Of Maine Anticavity Freshmint 1.1 mg/g 51009-0862-63 Tom's 85 g — — FDA listed —
Colgate Kpop Demon Hunters Bubble Pop 1.1 mg/g 35000-0092-46 Colgate-Palmolive 130 g — — FDA listed —
Colgate MaxFresh with Whitening KnockOut Fluoride 1.1 mg/g 35000-0972-58 Colgate-Palmolive 1 tube — — FDA listed —
Toms Of Maine Activated Charcoal Peppermint 1.1 mg/g 51009-0900-40 Tom's 1 tube — — FDA listed —
Colgate 2In1 Whitening With Stain Lifters 1.1 mg/g 35000-0076-81 Colgate-Palmolive 130 g — — FDA listed —
Colgate Optic White Stain Fighter Clean Mint 1.1 mg/g 35000-0287-02 Colgate-Palmolive 1 tube — — FDA listed —
Opalescence Whitening Original Cool Mint Cool Mint 1.1 mg/g 51206-0450-01 Ultradent 1 tube — — FDA listed —
Colgate Watermelon Burst 1.1 mg/g 35000-0070-81 Colgate-Palmolive 130 g — — FDA listed —
Colgate Optic White Stain Fighter Fresh Mint 1.1 mg/g 35000-0288-02 Colgate-Palmolive 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

🏛️
2025
On the market since
Jan 2025
📍
2026
Currently FDA-listed
1 year 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 Kids Berry Twist (this brand).

Top reported reactions

Pyrexia172
Weight Increased162
Nausea160
Vomiting159
Fatigue158
Pain158
Nasopharyngitis155

Age at onset

Child17
Adolescent6
Adult74
Elderly78

Reporter sex

1,128 reports
Male · 35%
Female · 65%
Unknown · 0%
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 233 45
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
00135-0809-01 1 TUBE in 1 CARTON (0135-0809-01) / 113 g in 1 TUBE 2025-01-06 Active
00135-0809-02 You're viewing this 23 g in 1 TUBE (0135-0809-02) 2025-01-06 Active
00135-0809-03 2 TUBE in 1 CARTON (0135-0809-03) / 113 g in 1 TUBE 2026-01-01 Active

Pack size FAQ

What quantity is in NDC 00135-0809-02?
NDC 00135-0809-02 contains 23 g — 23 g in 1 tube.
What NDC number is used to bill for this package of Sensodyne Pronamel Kids Berry Twist sodium fluoride 1.1 mg/g Paste?
Bill NDC 00135-0809-02 — the 11-digit billing format is 00135080902. 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) — 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 FDA registers it as 0135-0809-02, 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: 00135-0809-02, written without dashes as 00135080902. 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 00135-0809-02, the first segment (00135) is the labeler code FDA assigned to Haleon US Holdings LLC; the middle segment (0809) 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 2 other package presentations of this same product, including 1 tube (00135-0809-01), 2 tubes (00135-0809-03). 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 9 words ▾

Use • aids in the prevention of dental cavities.

⏱️ Dosage and Administration 81 words ▾

Directions • adults and children 2 years of age and older: o brush teeth thoroughly, preferably after each meal or at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing. o to minimize swallowing for children under 6 years of age, use a pea-sized amount and rinsing until good habits are established. • children under 2 years of age: Consult a dentist or doctor.

⚠️ Warnings 33 words ▾

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

🧪 Active Ingredient 9 words ▾

Active ingredient Sodium fluoride 0.254% (0.15% w/v fluoride ion)

🧪 Inactive Ingredients 19 words ▾

Inactive ingredients water, sorbitol, hydrated silica, glycerin, PEG-8, cocamidopropyl betaine, xanthan gum, flavor, sodium saccharin, sodium hydroxide, red 30

🎯 Purpose 2 words ▾

Purpose Anticavity

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00135-0808-01 · Haleon 00135-0810-01 · 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.