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COLGATE OPTIC WHITE STAIN FIGHTER FRESH MINT SODIUM FLUORIDE 1.1 mg/g Gel, Dentifrice, 1 tube — NDC 35000-0288-02 package photo

COLGATE OPTIC WHITE STAIN FIGHTER FRESH MINT SODIUM FLUORIDE 1.1 mg/g Gel, Dentifrice, 1 tube

by Colgate-Palmolive Company · 1 TUBE in 1 CARTON (35000-288-02) / 56.6 g in 1 TUBE
NDC 35000-0288-02
🏷️ FDA NDC (as labeled) 35000-288-02 billing pads the product segment with a zero
This package
Contains1 tube Pack sizes2 compare ↓
Also comes in: 107 g 35000-0288-59
OTC On market Non-controlled
🗂️ Data synced Sep 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) 35000-288-02
Product NDC 35000-288
11-digit billing NDC 35000028802
UNII 8ZYQ1474W7
Application # M021
SPL Set ID b1ef8277-9919-453c-9d21-da4666d952de
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-09-09
Route DENTAL
Dosage form GEL, DENTIFRICE
Substance SODIUM FLUORIDE
Why two NDCs? The FDA registers this code as 35000-288-02 — 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 → 35000-0288-02. 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

LabelerColgate-Palmolive Company
FDA applicationM021 (OTC MONOGRAPH DRUG)
Labeler code35000
First marketedSep 2026
Product typeHuman Otc Drug
Portfolio189 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 an over-the-counter toothpaste gel marketed under FDA's monograph rules for dental care products. It contains sodium fluoride, an ingredient commonly used in toothpastes to help strengthen tooth enamel and reduce the risk of tooth decay. The product is designed to be applied topically 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.

🧪 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 LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII 05JZI7B19X
    A plant-based thickener made from cellulose that holds water and creates texture. It works as a binder and thickening agent to give the medicine its proper consistency and help ingredients blend together.
  • 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 H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • 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 E4GA8884NN
    Phosphoric acid is a weak mineral acid used in medicines as a buffer and pH adjuster. It helps stabilize the product and control its acidity level.
  • UNII NL4J9F21N9
    Polyethylene glycol 600 is a synthetic liquid polymer used as a solvent and humectant in medicines. It helps dissolve active ingredients and keeps products from drying out.
  • UNII WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • 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 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 O352864B8Z
    A sodium salt compound used in medicines as a buffering agent to maintain pH stability and as a chelating agent to prevent unwanted chemical reactions during storage and mixing.
  • 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.

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

The official label also statesWater, Sorbitol, Hydrated Silica, PEG-12, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Potassium Hydroxide, Tetrasodium Pyrophosphate, Phosphoric Acid, Cocamidopropyl Betaine, Benzyl Alcohol, Sodium Saccharin, Blue 1.

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: 107 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
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/g 00135-0809-01 Haleon 1 tube — — 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/gthis 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

🏛️
2026
On the market since
Sep 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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 Colgate Optic White Stain Fighter Fresh Mint (this brand).

Top reported reactions

Pyrexia172
Weight Increased162
Nausea160
Vomiting159
Fatigue158
Pain158
Nasopharyngitis155

Age at onset

Child16
Adolescent6
Adult74
Elderly77

Reporter sex

1,067 reports
Male · 35%
Female · 65%
Unknown · 0%

Serious outcomes

Hospitalization379
Death347
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
35000-0288-02 You're viewing this 1 TUBE in 1 CARTON (35000-288-02) / 56.6 g in 1 TUBE 2026-09-09 Active
35000-0288-59 1 TUBE in 1 CARTON (35000-288-59) / 107 g in 1 TUBE 2026-09-09 Active

Pack size FAQ

What quantity is in NDC 35000-0288-02?
NDC 35000-0288-02 contains 1 tube — 1 tube in 1 carton / 56.6 g in 1 tube.
What NDC number is used to bill for this package of COLGATE OPTIC WHITE STAIN FIGHTER FRESH MINT SODIUM FLUORIDE 1.1 mg/g Gel, Dentifrice?
Bill NDC 35000-0288-02 — the 11-digit billing format is 35000028802. 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 35000-288-02, 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: 35000-0288-02, written without dashes as 35000028802. 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 35000-0288-02, the first segment (35000) is the labeler code FDA assigned to Colgate-Palmolive Company; the middle segment (0288) 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 Colgate-Palmolive Company. 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 (35000-0288-59). 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?
Colgate-Palmolive Company 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 5 words ▾

Use helps protect against cavities

⏱️ Dosage and Administration 60 words ▾

Directions adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 2 years ask a dentist or physician

⚠️ Warnings 32 words ▾

Warnings Keep out of 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 0.24% (0.15% w/v fluoride ion)

🧪 Inactive Ingredients 27 words ▾

Inactive ingredients Water, Sorbitol, Hydrated Silica, PEG-12, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Potassium Hydroxide, Tetrasodium Pyrophosphate, Phosphoric Acid, Cocamidopropyl Betaine, Benzyl Alcohol, Sodium Saccharin, Blue 1.

🎯 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 ↗
← 35000-0287-02 · Colgate-Palmolive 35000-0334-84 · Colgate-Palmolive →
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.