HomeNDC LookupIngredientsSodium Monofluorophosphate › 35000-0893-41
Colgate Optic White Stain Prevention SODIUM MONOFLUOROPHOSPHATE 1 mg/g Paste, Dentifrice — NDC 35000-0893-41 package photo

Colgate Optic White Stain Prevention SODIUM MONOFLUOROPHOSPHATE 1 mg/g Paste, Dentifrice

by Colgate-Palmolive Company · 1 TUBE in 1 CARTON (35000-893-41) / 116 g in 1 TUBE
NDC 35000-0893-41
🏷️ FDA NDC (as labeled) 35000-893-41 billing pads the product segment with a zero
This package
Contains116 g in 1 tube Pack sizes2 compare ↓
Also comes in: 121 g 35000-0893-43
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 →

🆔 Identity & classification

FDA NDC (as labeled) 35000-893-41
Product NDC 35000-893
11-digit billing NDC 35000089341
RxCUI 545626
UNII C810JCZ56Q
Application # M021
SPL Set ID d1350584-31cc-4cfb-bfcd-b07ff7e087d0
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-01-07
Route DENTAL
Dosage form PASTE, DENTIFRICE
Substance SODIUM MONOFLUOROPHOSPHATE
Why two NDCs? The FDA registers this code as 35000-893-41 — 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 → 35000-0893-41. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Caries prophylactic agents class.

Drug family (ATC) Caries prophylactic agents, Fluoride
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerColgate-Palmolive Company
FDA applicationM021 (OTC MONOGRAPH DRUG)
Labeler code35000
First marketedJan 2022
Product typeHuman Otc Drug
Portfolio176 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 Stain Prevention is a toothpaste containing sodium monofluorophosphate, a fluoride compound. This dentifrice is applied to teeth during brushing as an over-the-counter product marketed under the FDA's monograph rules for oral care products. Fluoride in toothpaste is commonly used to help strengthen tooth enamel and reduce cavity formation. This product also contains ingredients typically found in whitening toothpastes that are meant to help remove or prevent surface stains on teeth.

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 E54VE15114
    Povidone K15 is a synthetic polymer made from petroleum-derived materials. It acts as a binder and film-former in tablets and capsules, helping hold ingredients together and improve how the medicine dissolves in your body.
  • 527 mg / 1 g 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.

12 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, Hydrogen Peroxide (3% w/v), Flavor, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Disodium Pyrophosphate, Sodium Saccharin, Silica, 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 DailyMedingredient 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: 121 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
biotene 1.4 mg/g 00135-0577-01 Haleon 1 tube FDA listed
Whitening .14 g/100g 11673-0385-09 Target 2 tubes FDA listed
Kids Strawberry FTP .13 g/100g 11673-0441-01 Target 1 tube FDA listed
Simple Truth Kids Flouride .76 g/100g 30142-0146-79 Kroger 119 g FDA listed
Natural Adult Fluoride .76 g/100g 30142-0223-39 Kroger 1 tube FDA listed
Colgate Revitalizing White 1 mg/g 35000-0017-46 Colgate-Palmolive 1 tube FDA listed
Colgate Cavity Protection Great Regular Flavor 1 mg/g 35000-0060-48 Colgate-Palmolive 1 tube FDA listed
Hello Whipped Peppermint Stick Flavor 1.1 mg/g 35000-0512-10 Colgate-Palmolive 1 tube FDA listed
Hello Whipped Mellow Mint Dream Flavor 1.1 mg/g 35000-0513-10 Colgate-Palmolive 1 tube FDA listed
Hello Activated Charcoal 1.1 mg/g 35000-0678-10 Colgate-Palmolive 1 tube Discontinued
Hello Naturally Whitening 1.1 mg/g 35000-0682-10 COLGATE 1 tube FDA listed
Colgate Optic White Pro Series Stain Prevention 1.1 mg/g 35000-0747-16 Colgate-Palmolive 1 tube Discontinued
Colgate Optic White Stain Prevention 1 mg/gthis 35000-0893-41 Colgate-Palmolive 1 tube FDA listed
COLGATE Great Regular Flavor 1 mg/g 35000-0913-01 Colgate-Palmolive 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
Colgate Sparkling White Mint Zing 1 mg/g 35000-0919-46 Colgate-Palmolive 1 tube Discontinued
COLGATE Baking Soda and Peroxide Whitening Brisk Mint 1 mg/g 35000-0959-46 Colgate-Palmolive 1 tube Discontinued
Colgate Optic White Platinum Stain-Less 1 mg/g 35000-0973-32 Colgate-Palmolive 1 tube FDA listed
Colgate Essentials 1 mg/g 35000-0974-46 Colgate-Palmolive 1 tube Discontinued
Colgate Optic White Advanced Icy Fresh 1 mg/g 35000-0977-32 Colgate-Palmolive 1 tube FDA listed
Colgate Optic White Advanced Sparkling White 1 mg/g 35000-0978-14 Colgate-Palmolive 1 tube FDA listed
Colgate Optic White Renewal High Impact White 1 mg/g 35000-0982-15 Colgate-Palmolive 1 tube Discontinued
MediChoice Fluoride 7.6 mg/g 39892-0602-01 O&M 17 g FDA listed
Natures Promise Childrens Fluoride Strawberry .13 g/100g 41520-0724-29 Foodhold 119 g FDA listed
Charm Tex FLUORIDE .1 g/100g 42086-0051-01 Jiangsu 720 tubes FDA listed
United Dental Kit 42509-0134-01 Wessco 1 kit FDA listed
Colgate Anticavity 7.6 mg/g 42555-0060-45 Colgate-Palmolive 10 g FDA listed
365 Everyday Value Cavity Fighting and Whitening .13 g/100g 42681-5002-09 Whole 1 tube Discontinued
365 Everyday Value Kids Flouride .13 g/100g 42681-5276-09 Whole 119 g FDA listed
Tom Whole Care Peppermint fights cavities whitening fresh breath helps fight tartar 1.4 mg/g 51009-0202-04 Tom's 1 tube FDA listed
Toms Whole Care Spearmint fights cavities whitening fresh breath helps fight tartar 1.4 mg/g 51009-0203-04 Tom's 1 tube FDA listed
Toms Wicked Fresh Cool Peppermint fresh breath / cavity protection 1.4 mg/g 51009-0205-47 Tom's 1 tube Discontinued
Toms Wicked Fresh Spearmint Ice fresh breath / cavity protection 1.4 mg/g 51009-0206-47 Tom's 1 tube Discontinued
Toms Whole Care Cinnamon Clove FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR 1.4 mg/g 51009-0219-04 Tom's 1 tube FDA listed
Toms Kids Watermelon Wiggle 1 mg/g 51009-0854-42 Tom's 119 g Discontinued
Toms Of Maine Whole Care Spearmint 1 mg/g 51009-0857-69 Tom's 1 tube FDA listed
Toms Of Maine Whole Care Spearmint 1 mg/g 51009-0858-69 Tom's 1 tube FDA listed
Toms Of Maine Wicked Fresh Cool Peppermint 1 mg/g 51009-0859-07 Tom's 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 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
Toms Of Maine Kids Outrageous Orange Mango 1 mg/g 51009-0911-51 Tom's 144 g FDA listed
Toms Of Maine Wicked Cool Mild Mint 1 mg/g 51009-0912-51 Tom's 144 g FDA listed
Freshmint Anticavity Fluoride 7.6 mg/g 51824-0067-01 New 17 g FDA listed
Anti Cavity Fluoride .76 g/100g 52000-0107-01 Universal 181 g FDA listed
Advanced Whitening Anti Cavity Fluoride .76 g/100g 52000-0108-01 Universal 181 g FDA listed
Universal Anti-Cavity Fluoride .76 g/100g 52000-0111-01 Universal 181 g FDA listed
Universal Advanced Whitening Anti-Cavity Fluoride .76 g/100g 52000-0112-01 Universal 181 g FDA listed
Medpride 7.6 mg/g 52410-9005-03 Shield 42.5 g FDA listed
PERIOSCIENCES HYDRATING AO Pro 1.3 mg/mL 53238-0003-90 PERIOSCIENCES 1 tube FDA listed
Nature Mint Anticavity 7.6 mg/g 53247-0129-01 Bob 7.94 g FDA listed
Nature Mint Anticavity 7.6 mg/g 53247-0144-01 Bob 7.94 g Discontinued
SparkleFresh Flouride Toothpaste 1 mg/g 53329-0083-21 Medline 42.5 g FDA listed
Rexall Travel Toothbrush and Tooth-paste 55910-0087-01 Old 1 kit FDA listed
Colgate Anticavity Kit 7.6 mg/g 56153-0001-05 Ming 1 tube FDA listed
Colgate Anticavity Kit 7.6 mg/g 56153-0002-05 Ming 1 tube FDA listed
First Class Kit 7.6 mg/g 58701-0001-10 American 1 tube FDA listed
Business Class Kit 7.6 mg/g 58701-0002-10 American 1 tube FDA listed
United Airlines Business Class Kit 7.6 mg/g 58733-0001-10 United 1 tube FDA listed
smart way MINT cavity protection .13 g/100g 59450-0010-01 The 1 tube FDA listed
AP-24 Whitening 7.6 mg/g 62839-1155-01 NSE 110 g FDA listed
COLGATE Great Regular Flavor 1 mg/g 65954-0060-01 Mission 1 tube FDA listed
Colgate ULTRA BRITE Baking Soda and Peroxide Whitening 1.1 mg/g 65954-0063-60 Mission 1 tube FDA listed
Colgate Sparkling White Mint Zing 1 mg/g 65954-0068-48 Mission 1 tube FDA listed
COLGATE Baking Soda and Peroxide Whitening Brisk Mint 1 mg/g 65954-0765-48 Mission 1 tube FDA listed
Colgate Baking Soda and Peroxide Whitening Oxygen Bubbles Frosty Mint 1 mg/g 65954-0768-35 Mission 3 tubes FDA listed
Colgate Optic White Platinum Stain-Less 1 mg/g 65954-0785-32 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
Morning Fresh 76 mg/g 67777-0175-11 Dynarex 1 tube FDA listed
Sodium Monofluorophosphate 760 mg/g 67777-0181-02 Dynarex 144 tubes FDA listed
Morning Fresh Mint Toothpaste, with Fluoride 1.3 mg/mL 67777-0190-03 Dynarex 144 tubes FDA listed
Fluoride .76 g/g 68599-9571-01 McKesson 1 g FDA listed
Murchison Hume Dental Kit 69491-0034-01 Buzz 1 kit FDA listed
Ipana Wintergreen Fluoride .1 g/100g 69510-0010-19 Maxill 1 tube FDA listed
Ipana Bucky Beaver Bubble Gum Childrens Fluoride .1 g/100g 69510-0020-19 Maxill 1 tube FDA listed
Listerine Essential Care 1.3 mg/g 69968-0701-04 Kenvue 1 tube FDA listed
Brush Buddies Value 2 pack Whitening .76 g/100g 70108-0030-01 Ashtel 2 tubes FDA listed
Brush Buddies 2 VALUE PACK CAVITY PROTECTION ANTI-CAVITY FLUORIDE .15 g/100g 70108-0185-01 Ashtel 2 tubes FDA listed
Charm Tex FLUORIDE .1 g/100g 71035-0001-01 Yangzhou 720 tubes FDA listed
dentalux ANTI-CAVITY FLUORIDE .13 g/100g 71141-0186-10 Lidl 1 tube FDA listed
Orazen .1 g/100g 71927-0102-01 Orazen 1 tube FDA listed
Colgate 5g Toothbrush Kit 72845-0000-00 Wuhan 1 kit FDA listed
Colgate Anticavity 73234-0040-00 MING 1 kit FDA listed
Cloveden Tooth .76 g/100g 73242-1112-02 DONG 1 tube FDA listed
White Glo Micellar 73656-0003-00 WHITE 1 kit FDA listed
White Glo Bio-Enzyme 73656-0005-00 WHITE 1 kit FDA listed
White Glo Professional Choice 73656-0007-00 WHITE 1 kit FDA listed
White Glo Charcoal 73656-0009-00 WHITE 1 kit FDA listed
White Glo Maximum White Charcoal 73656-0013-00 WHITE 1 kit FDA listed
White Glo Instant White 73656-0015-00 WHITE 1 kit FDA listed
White Glo Mouthwash Protection 73656-0017-00 WHITE 1 kit FDA listed
White Glo Activated Charcoal Twin Pack 73656-0020-00 WHITE 1 kit FDA listed
White Glo Professional Choice Twin Pack 73656-0024-00 WHITE 1 kit FDA listed
White Glo Advantage Anticavity Fluoride Purple 7.6 mg/g 73656-0026-00 WHITE 1 tube FDA listed
White Glo Advantage Anticavity Professional Whitening 7.6 mg/g 73656-0027-00 WHITE 1 tube FDA listed
White Glo Instant White Blue Foam Optical Enhancers Fluoride Anticavity Value 2 pack and Toothbrush 73656-0028-00 WHITE 1 kit FDA listed
White Glo Coffee and Tea Stain Remover Fluoride Anticavity 73656-0030-00 WHITE 1 kit FDA listed
Optimax Anticavity Fluoride Watermelon 7.6 mg/g 73656-0032-00 WHITE 1 tube FDA listed
Optimax Anticavity Fluoride Cotton Candy 7.6 mg/g 73656-0033-00 WHITE 1 tube FDA listed
Optimax Purple Anticavity Fluoride 73656-0034-00 WHITE 1 kit FDA listed
Optimax Professional Whitening Anticavity Fluoride 73656-0036-00 WHITE 1 kit FDA listed
Optimax Professional Whitening Anticavity Fluoride 73656-0038-00 WHITE 1 kit FDA listed
Optimax Purple Anticavity Fluoride 73656-0039-00 WHITE 1 kit FDA listed
White Glo Charcoal Baking Soda Maximum White Fluoride Anticavity 73656-0041-00 White 1 kit FDA listed
White Glo Coffee and Tea Stain Remover Fluoride Anticavity 73656-0042-00 White 1 kit FDA listed
White Glo Professional Choice Fluoride Anticavity 7.6 mg/g 73656-0043-00 White 2 tubes FDA listed
White Glo Mouthwash Protect Fluoride Anticavity 73656-0044-00 White 1 kit FDA listed
White Glo Extreme White Whitening 7.6 mg/g 73656-0046-00 White 2 tubes FDA listed
White Glo Purple Color Corrector Fluoride Anticavity 7.6 mg/g 73656-0047-00 White 2 tubes FDA listed
Optimax Anticavity Fluoride Bubblegum 7.6 mg/g 73656-0048-00 White 1 tube FDA listed
Optimax Anticavity Fluoride Raspberry 7.6 mg/g 73656-0049-00 White 1 tube FDA listed
Freshen Up .76 g/100g 77782-0005-20 MKJ 2 bottles FDA listed
Colgate Anticavity 79940-0010-00 FORMIA 1 kit FDA listed
Colgate Anticavity 79940-0012-00 FORMIA 1 kit FDA listed
Colgate Anticavity 79940-0013-00 FORMIA 1 kit FDA listed
Coffe Tea Stain Remover Tooth .76 g/100g 82168-0001-01 Guangzhou 150 g FDA listed
Instant Whitening .76 g/100g 82168-0002-01 Guangzhou 150 g FDA listed
Professional Choice .76 g/100g 82168-0003-01 Guangzhou 150 g FDA listed
Professional whitening tooth .76 g/100g 82168-0004-01 Guangzhou 100 g FDA listed
purple tooth .76 g/100g 82168-0005-01 Guangzhou 100 g FDA listed
Zohar Fluoride Anti Cavity Coolmint Flavour 7.6 mg/g 84045-0004-00 ZOHAR 1 tube Discontinued
Zohar Fluoride Anti-Cavity Regular Mint Flavour 7.6 mg/g 84045-0005-00 ZOHAR 1 tube Discontinued
Zohar Fluoride Anti Cavity Fresh Mint Flavor 7.6 mg/g 84045-0006-00 ZOHAR 1 tube Discontinued
DeCure 7.6 mg/g 84132-0100-10 Scope 10 g FDA listed
Carekon Anti-Cavity Fluoride .76 g/100g 84345-0086-01 Hunan 1 tube FDA listed
Nature Mint Anti cavity Fluoride .1 g/100g 85891-0009-01 SPARROW 720 tubes Discontinued
Fluoride Anticavity,Toothpaste .76 g 87576-0332-02 Shulisa 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
Optic White Pro Series Vibrant Clean 1 mg/g 35000-0795-63 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

🏛️
2022
On the market since
Jan 2022
📍
2026
Currently FDA-listed
4 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

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

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

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
35000-0893-43 1 TUBE in 1 CARTON (35000-893-43) / 121 g in 1 TUBE 2022-01-07 Discontinued by firm
35000-0893-41 You're viewing this 1 TUBE in 1 CARTON (35000-893-41) / 116 g in 1 TUBE 2022-01-07 Active

Pack size FAQ

What quantity is in NDC 35000-0893-41?
NDC 35000-0893-41 is listed by the FDA — 1 tube in 1 carton / 116 g in 1 tube.
What NDC number is used to bill for this package of Colgate Optic White Stain Prevention SODIUM MONOFLUOROPHOSPHATE 1 mg/g Paste, Dentifrice?
Bill NDC 35000-0893-41 — the 11-digit billing format is 35000089341. 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 35000-893-41, 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: 35000-0893-41, written without dashes as 35000089341. 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 35000-0893-41, the first segment (35000) is the labeler code FDA assigned to Colgate-Palmolive Company; the middle segment (0893) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (41) 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 (35000-0893-43). 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 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 Monofluorophosphate 0.76% (0.12% w/v fluoride ion)

🧪 Inactive Ingredients 26 words

Inactive ingredients Propylene Glycol, Calcium Pyrophosphate, PVP, PEG/PPG-116/66 Copolymer, Hydrogen Peroxide (3% w/v), Flavor, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Disodium Pyrophosphate, Sodium Saccharin, Silica, Sucralose, BHT.

🎯 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 ↗
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