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Colgate Sensitive ProRelief Whitening Stannous Fluoride 1.1 mg/g Paste, Dentifrice — NDC 35000-0285-47 package photo

Colgate Sensitive ProRelief Whitening Stannous Fluoride 1.1 mg/g Paste, Dentifrice

by Colgate-Palmolive Company · 1 TUBE in 1 CARTON (35000-285-47) / 144 g in 1 TUBE
NDC 35000-0285-47
🏷️ FDA NDC (as labeled) 35000-285-47 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Sep 17, 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) 35000-285-47
Product NDC 35000-285
11-digit billing NDC 35000028547
RxCUI 416784
UNII 3FTR44B32Q
Application # M021
SPL Set ID 8d9d485e-6efb-4bca-a779-9e8b0aeed14c
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-08-31
Route DENTAL
Dosage form PASTE, DENTIFRICE
Substance STANNOUS FLUORIDE
Why two NDCs? The FDA registers this code as 35000-285-47 — 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 → 35000-0285-47. 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
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.

🏭 Manufacturer & labeler

LabelerColgate-Palmolive Company
FDA applicationM021 (OTC MONOGRAPH DRUG)
Labeler code35000
First marketedAug 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 a toothpaste containing stannous fluoride, an over-the-counter oral care product regulated under FDA's monograph guidelines for dentifrice drugs. Stannous fluoride is typically used in toothpastes to help strengthen tooth enamel and reduce cavity formation when used regularly during brushing. The product is also marketed for whitening purposes as part of regular dental hygiene.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color White
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 K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • 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 OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • 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 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 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • 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 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • 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.
  • UNII 1E2MCT2M62
    Zinc phosphate is an inorganic compound that acts as a buffer and pH stabilizer in medicines. It helps maintain the acidity or alkalinity of the product to protect the drug's stability and effectiveness.

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

The official label also statesInactive ingredients Water, Sorbitol, Hydrated Silica, Glycerin, PEG-12, Tetrasodium Pyrophosphate, Flavor, Sodium Lauryl Sulfate, Zinc Phosphate, Cellulose Gum, Sodium Citrate, Microcrystalline Cellulose, Sodium Saccharin, Cocamidopropyl Betaine, Xanthan Gum, Citric Acid, Sucralose, Titanium Dioxide.

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Colgate Total SF Advanced Deep Clean 1.1 mg/g 35000-0169-25 Colgate-Palmolive 1 tube — — Discontinued —
Colgate Total SF Advanced Whitening 1.1 mg/g 35000-0271-18 Colgate-Palmolive 1 cello — — FDA listed —
Colgate Total SF Clean Mint 1.1 mg/g 35000-0272-21 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Total SF Whitening 1.1 mg/g 35000-0274-14 COLGATE 1 tube — — FDA listed —
parodontax Active Gum Repair 1.1 mg/g 00135-0637-01 Haleon 1 tube — — FDA listed —
Colgate Total Enamel Strength 1.1 mg/g 35000-0284-63 Colgate-Palmolive 1 tube — — FDA listed —
Sensodyne Complete Protection 1.1 mg/g 00135-0573-02 Haleon 1 tube — — FDA listed —
Colgate Total SF Deep Clean 1.1 mg/g 35000-0270-32 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Total SF Whitening 1.1 mg/g 35000-0275-32 Colgate-Palmolive 1 tube — — FDA listed —
parodontax 1.1 mg/g 00135-0601-01 Haleon 1 tube — — FDA listed —
parodontax Active Gum Repair Breath Freshener 1.1 mg/g 00135-0737-01 Haleon 1 tube — — FDA listed —
Colgate Total SF Whitening 1.1 mg/g 35000-0176-14 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Total SF Advanced Whitening 1.1 mg/g 35000-0178-14 Colgate-Palmolive 1 tube — — Discontinued —
Colgate Total Plaque Pro Release Fresh Mint 1.1 mg/g 35000-0180-63 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Total Plaque Pro Release Whitening 1.1 mg/g 35000-0181-63 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Total SF Fresh Mint Stripe 1.1 mg/g 35000-0273-32 COLGATE 1 tube — — FDA listed —
Colgate Total SF Clean Mint 1.1 mg/g 35000-0172-14 Colgate-Palmolive 1 tube — — Discontinued —
Colgate Total SF Mint Stripe Gel 1.1 mg/g 35000-0174-32 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Total Whitening Charcoal 1.1 mg/g 35000-0571-32 Colgate-Palmolive 1 tube — — FDA listed —
parodontax Active Gum Repair Whitening 1.1 mg/g 00135-0638-03 Haleon 1 tube — — FDA listed —
Colgate Total Gum Protect Fresh Mint 1.1 mg/g 35000-0278-63 COLGATE 1 tube — — FDA listed —
Colgate Total SF Whitening Gel 1.1 mg/g 35000-0175-32 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Total Gum Protect Whitening 1.1 mg/g 35000-0277-63 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Total Sensitivity Mineral Shield 1.1 mg/g 35000-0283-63 Colgate-Palmolive 1 tube — — FDA listed —
Sensodyne Complete Protection Extra Fresh 1.1 mg/g 00135-0572-02 Haleon 1 tube — — FDA listed —
parodontax 1.1 mg/g 00135-0598-01 Haleon 1 tube — — FDA listed —
parodontax Complete Protection 1.1 mg/g 00135-0634-01 Haleon 1 tube — — FDA listed —
Total Tp Clean Mint Pst 1.1 mg/g 65954-0833-25 Mission 1 tube — — FDA listed —
Colgate Total Active Prevention Clean Mint 1.1 mg/g 35000-0431-25 Colgate-Palmolive 1 tube — — FDA listed —
parodontax Complete Protection 1.1 mg/g 00135-0627-01 Haleon 1 tube — — FDA listed —
Colgate Total Whitening Fresh Boost 1.1 mg/g 35000-0179-48 Colgate-Palmolive 1 tube — — Discontinued —
Colgate Total SF Whitening Charcoal 1.1 mg/g 35000-0276-47 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Total Plaque Cleanse 1.1 mg/g 35000-0282-63 Colgate-Palmolive 1 tube — — FDA listed —
Hello Mighty Multi tasker 1.1 mg/g 35000-0681-10 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Total SF Clean Mint 1.1 mg/g 67751-0224-01 Navajo 1 tube — — FDA listed —
Colgate Sensitive ProRelief Whitening 1.1 mg/gthis 35000-0285-47 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
Aug 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 Stannous Fluoride — the ingredient across all brands.

Top reported reactions

Oral Discomfort101
Oral Pain51
Toothache46
Stomatitis45
Gingival Pain41
Oral Mucosal Exfoliation34
Lip Swelling33

Age at onset

Child1
Adolescent1
Adult15
Elderly12

Reporter sex

758 reports
Male · 33%
Female · 66%
Unknown · 0%

Serious outcomes

Hospitalization58
Disabling23
Life-threatening9
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 267 7
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
35000-0285-47 You're viewing this 1 TUBE in 1 CARTON (35000-285-47) / 144 g in 1 TUBE 2026-08-31 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 35000-285-47, 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: 35000-0285-47, written without dashes as 35000028547. 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 35000-0285-47, the first segment (35000) is the labeler code FDA assigned to Colgate-Palmolive Company; the middle segment (0285) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (47) 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.
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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 36 words ▾

Uses aids in the prevention of cavities helps prevent gingivitis helps interfere with harmful effects of plaque associated with gingivitis builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact

⏱️ Dosage and Administration 66 words ▾

Directions adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristled toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist. Make sure to brush all sensitive areas of the teeth. do not swallow. children under 12 years of age: consult a dentist.

⚠️ Warnings 121 words ▾

Warnings When using this product for sensitivity, do not use longer than 4 weeks unless recommended by a dentist. Stop use and ask a dentist if the sensitivity problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

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. Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth.

These may be signs of periodontitis, a serious form of gum disease.

📦 Storage and Handling 42 words ▾

Other information products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist. this Colgate product is specially formulated to help prevent staining.

🧪 Active Ingredient 9 words ▾

Active ingredient Stannous Fluoride 0.454% (0.15% w/v fluoride ion)

🧪 Inactive Ingredients 35 words ▾

Inactive ingredients Inactive ingredients Water, Sorbitol, Hydrated Silica, Glycerin, PEG-12, Tetrasodium Pyrophosphate, Flavor, Sodium Lauryl Sulfate, Zinc Phosphate, Cellulose Gum, Sodium Citrate, Microcrystalline Cellulose, Sodium Saccharin, Cocamidopropyl Betaine, Xanthan Gum, Citric Acid, Sucralose, Titanium Dioxide.

🎯 Purpose 4 words ▾

Purposes Anticavity, Antigingivitis, Antisensitivity

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 35000-0284-63 · Colgate-Palmolive 35000-0287-02 · 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.