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Colgate Optic White Renewal High Impact White SODIUM MONOFLUOROPHOSPHATE 1 mg/g Paste, Dentifrice — NDC 35000-0957-62 package photo

Colgate Optic White Renewal High Impact White SODIUM MONOFLUOROPHOSPHATE 1 mg/g Paste, Dentifrice

by Colgate-Palmolive Company · 2 TUBE in 1 CARTON (35000-957-62) / 85 g in 1 TUBE
NDC 35000-0957-62
🏷️ FDA NDC (as labeled) 35000-957-62 billing pads the product segment with a zero
This package
Contains85 g in 1 tube Pack sizes2 compare ↓
Also comes in: 85 g 35000-0957-63
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) 35000-957-62
Product NDC 35000-957
11-digit billing NDC 35000095762
Application # M021
SPL Set ID 64bf6a4a-72da-46e0-9540-49368c8202e2
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-11-01
Marketing end 2027-05-01
Route DENTAL
Dosage form PASTE, DENTIFRICE
Substance SODIUM MONOFLUOROPHOSPHATE
Why two NDCs? The FDA registers this code as 35000-957-62 — 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 → 35000-0957-62. 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 marketedNov 2023
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?

Colgate Optic White Renewal High Impact White is a toothpaste containing sodium monofluorophosphate, a fluoride compound. This product is sold as an over-the-counter oral care product under FDA's monograph rules for dentifrices. Sodium monofluorophosphate is typically used in toothpastes to help strengthen tooth enamel and reduce the risk of cavities when used regularly as part of 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.

💊 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 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII X69NU20D19
    Calcium pyrophosphate is a mineral salt compound used in medications as a buffering agent and pH regulator. It helps stabilize the medicine and can also serve as a filler to provide bulk to tablets or capsules.
  • UNII BBX060AN9V
    Hydrogen peroxide is a chemical solution used in medicines as a cleansing agent or preservative. It helps prevent bacterial growth and is sometimes used in oral or topical formulations.
  • UNII JP0CK963E0
    A synthetic polymer made from polyethylene glycol and polypropylene glycol chains. It acts as a solubilizer and emulsifier to help dissolve and blend oil and water components in medicines.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII H5WVD9LZUD
    A mineral salt used in medicines as a buffer to help maintain proper acidity levels and as a texturing agent in solid dosage forms. It helps stabilize the medicine and improve its shelf life.
  • 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 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 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 statesPropylene Glycol, Calcium Pyrophosphate, PVP, PEG/PPG-116/66 Copolymer, Water, Hydrogen Peroxide (5% w/w), Silica, Flavor, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Sodium Saccharin, Disodium Pyrophosphate, Sucralose, BHT.

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: 85 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 Baking Soda and Peroxide Whitening Brisk Mint 1 mg/g 65954-0765-48 Mission 1 tube — — FDA listed —
Colgate Optic White Renewal High Impact White 1 mg/g 35000-0982-15 Colgate-Palmolive 1 tube — — Discontinued —
Colgate Baking Soda and Peroxide Whitening Oxygen Bubbles Frosty Mint 1 mg/g 65954-0768-35 Mission 3 tubes — — FDA listed —
Colgate Revitalizing White 1 mg/g 35000-0017-46 Colgate-Palmolive 1 tube — — FDA listed —
COLGATE Baking Soda and Peroxide Whitening Brisk Mint 1 mg/g 35000-0959-46 Colgate-Palmolive 1 tube — — Discontinued —
COLGATE Great Regular Flavor 1 mg/g 65954-0060-01 Mission 1 tube — — FDA listed —
Colgate Essentials 1 mg/g 65954-0786-46 Mission 1 tube — — FDA listed —
Colgate Great Regular Flavor 1 mg/g 67751-0118-01 Navajo 1 tube — — FDA listed —
Colgate Optic White Stain Prevention 1 mg/g 35000-0893-43 Colgate-Palmolive 1 tube — — Discontinued —
SparkleFresh Flouride Toothpaste 1 mg/g 53329-0083-21 Medline 42.5 g — — FDA listed —
Colgate Sparkling White Mint Zing 1 mg/g 65954-0068-48 Mission 1 tube — — FDA listed —
Colgate Optic White Platinum Stain-Less 1 mg/g 65954-0785-32 Mission 1 tube — — FDA listed —
COLGATE Great Regular Flavor 1 mg/g 35000-0913-01 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Sparkling White Mint Zing 1 mg/g 35000-0919-46 Colgate-Palmolive 1 tube — — Discontinued —
Colgate Optic White Platinum Stain-Less 1 mg/g 35000-0973-32 Colgate-Palmolive 1 tube — — Discontinued —
Colgate Optic White Advanced Icy Fresh 1 mg/g 35000-0977-32 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Essentials 1 mg/g 35000-0974-46 Colgate-Palmolive 1 tube — — Discontinued —
Colgate Optic White Advanced Sparkling White 1 mg/g 35000-0978-14 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Optic White Renewal Brilliant Shine 1 mg/g 35000-0955-63 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Baking Soda And Peroxide Whitening Oxygen Bubbles Frosty Mint 1 mg/g 35000-0960-60 Colgate-Palmolive 1 tube — — FDA listed —
TP OW Pro Series Stain Prevention 1 mg/g 35000-0939-62 Colgate-Palmolive 2 tubes — — FDA listed —
TP OW Pro Series Vividly Fresh 1 mg/g 35000-0940-63 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Optic White Pro Series Express White 1 mg/g 35000-0794-62 Colgate-Palmolive 2 tubes — — FDA listed —
Toms Kids Watermelon Wiggle 1 mg/g 51009-0854-42 Tom's 119 g — — Discontinued —
Optic White Pro Series Vibrant Clean 1 mg/g 35000-0795-63 Colgate-Palmolive 1 tube — — FDA listed —
Toms Of Maine Wicked Fresh Cool Peppermint 1 mg/g 51009-0859-07 Tom's 1 tube — — FDA listed —
ULTRA BRITE Baking Soda and Peroxide Whitening Cool Mint 1 mg/g 35000-0916-60 Colgate-Palmolive 1 tube — — FDA listed —
Toms Of Maine Wicked Fresh Spearmint Ice 1 mg/g 51009-0860-07 Tom's 1 tube — — FDA listed —
Toms Of Maine Wicked Cool Mild Mint 1 mg/g 51009-0912-51 Tom's 144 g — — FDA listed —
Toms Of Maine Whole Care Spearmint 1 mg/g 51009-0857-69 Tom's 1 tube — — FDA listed —
Toms Of Maine Kids Outrageous Orange Mango 1 mg/g 51009-0911-51 Tom's 144 g — — FDA listed —
Toms Of Maine Whole Care Spearmint 1 mg/g 51009-0858-69 Tom's 1 tube — — FDA listed —
Toms Of Maine Whole Care Wintermint 1 mg/g 51009-0902-40 Tom's 1 tube — — FDA listed —
Toms Of Maine Kids Silly Strawberry 1 mg/g 51009-0910-10 Tom's 1 tube — — Discontinued —
Colgate Optic White Advanced Stain Prevention 1 mg/g 35000-0075-32 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Optic White Platinum High Impact White 1 mg/g 35000-0066-41 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Optic White Platinum Stain Prevention Sparkling Mint 1 mg/g 35000-0074-41 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Optic White Renewal High Impact White 1 mg/gthis 35000-0957-62 Colgate-Palmolive 2 tubes — — 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

🏛️
2023
On the market since
Nov 2023
📍
2026
Currently FDA-listed
3 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Colgate Optic White Renewal High Impact White (this brand).

Top reported reactions

Dental Caries3
Pelvic Fracture2
Abdominal Discomfort1
Abdominal Pain Upper1
Ageusia1
Anaphylactic Shock1
Asthma1

Age at onset

Adult2

Reporter sex

13 reports
Male · 69%
Female · 31%

Serious outcomes

Hospitalization3
Life-threatening1
Disabling1
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 2 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
35000-0957-62 You're viewing this 2 TUBE in 1 CARTON (35000-957-62) / 85 g in 1 TUBE 2023-11-01 Active
35000-0957-63 1 TUBE in 1 CARTON (35000-957-63) / 85 g in 1 TUBE 2023-11-01 Active

Pack size FAQ

What quantity is in NDC 35000-0957-62?
NDC 35000-0957-62 is listed by the FDA — 2 tube in 1 carton / 85 g in 1 tube.
What NDC number is used to bill for this package of Colgate Optic White Renewal High Impact White SODIUM MONOFLUOROPHOSPHATE 1 mg/g Paste, Dentifrice?
Bill NDC 35000-0957-62 — the 11-digit billing format is 35000095762. 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 35000-957-62, 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: 35000-0957-62, written without dashes as 35000095762. 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 35000-0957-62, the first segment (35000) is the labeler code FDA assigned to Colgate-Palmolive Company; the middle segment (0957) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (62) 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 it is currently marketed — but Colgate-Palmolive Company has reported a marketing end date of 2027-05-01, after which this package is expected to stop being marketed. 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 (35000-0957-63). 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.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 35000-0955-63 · Colgate-Palmolive 35000-0958-46 · 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.