HomeNDC LookupIngredientsSodium Fluoride › 35000-0028-63
Colgate MaxClean with Whitening Smartfoam Sodium Fluoride 1.1 mg/g Paste, Dentifrice — NDC 35000-0028-63 package photo

Colgate MaxClean with Whitening Smartfoam Sodium Fluoride 1.1 mg/g Paste, Dentifrice

by Colgate-Palmolive Company · 1 TUBE in 1 CARTON (35000-028-63) / 178 g in 1 TUBE
NDC 35000-0028-63
🏷️ FDA NDC (as labeled) 35000-028-63 billing pads the product segment with a zero
This package
Contains178 g in 1 tube Pack sizes2 compare ↓
Also comes in: 170 g 35000-0028-60
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) 35000-028-63
Product NDC 35000-028
11-digit billing NDC 35000002863
RxCUI 416783
UNII 8ZYQ1474W7
Application # M021
SPL Set ID c712ae6b-eff3-4c54-b1fc-37304758d059
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-10-24
Marketing end 2026-12-01
Route DENTAL
Dosage form PASTE, DENTIFRICE
Substance SODIUM FLUORIDE
Why two NDCs? The FDA registers this code as 35000-028-63 — 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 → 35000-0028-63. 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 marketedOct 2019
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 MaxClean with Whitening Smartfoam is a toothpaste containing sodium fluoride, an active ingredient commonly used in over-the-counter dental products. Sodium fluoride is typically included in toothpastes to help strengthen tooth enamel and reduce the risk of tooth decay. This product is an over-the-counter monograph drug, meaning it is marketed under FDA's established rules for toothpaste products rather than through an individual product application.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 170 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 Gentle Mint 1.5 mg/g 00135-0558-01 Haleon 1 tube FDA listed
TheraBreath Fresh Breath Anticavity Mild Mint .24 g/100g 10237-0263-04 Church 1 tube FDA listed
Therabreath Whitening .243 g/100g 10237-0272-04 Church 1 tube FDA listed
AIM Bubble Berry 2.4 mg/g 10237-0625-44 Church 1 tube FDA listed
AIM CAVITY PROTECTION Multi Benefit 2.4 mg/g 10237-0633-55 Church 1 tube FDA listed
AIM TARTAR CONTROL Plus Mouthwash and Whitening 2.4 mg/g 10237-0635-55 Church 1 tube FDA listed
AIM Whitening with Baking Soda 2.4 mg/g 10237-0636-45 Church 1 tube FDA listed
CLOSE UP Freshening with Mouthwash 2.4 mg/g 10237-0644-40 Church 1 tube FDA listed
Pepsodent Complete Care Original 2.4 mg/g 10237-0651-55 Church 1 tube FDA listed
Peroxicare 2.4 mg/g 10237-0655-12 Church 2 tubes FDA listed
Advance White Tartar Control Breath Freshening 2.4 mg/g 10237-0656-60 Church 1 tube FDA listed
Advance White Extreme Whitening Tartar Control 2.4 mg/g 10237-0658-09 Church 1 tube FDA listed
Enamel Defense .24 mg/g 10237-0666-09 Church 1 tube FDA listed
Essentials Healthy Teeth and Gums 2.4 mg/g 10237-0670-09 Church 1 tube Discontinued
Essentials Whiten and Strengthen 2.4 mg/g 10237-0672-09 Church 1 tube Discontinued
Complete Care Whole Mouth Protection 1.5 mg/g 10237-0675-09 Church 1 tube FDA listed
A and H Plus Therabreath Breath Freshners .243 g/100g 10237-0676-55 Church 156 g FDA listed
Arm and Hammer 2.4 mg/g 10237-0679-06 Church 1 tube FDA listed
Arm and Hammer 2.4 mg/g 10237-0680-06 Church 1 tube FDA listed
Orajel Kids Superman 1.5 mg/g 10237-0732-42 Church 119 g FDA listed
Orajel SuperMario 2.4 mg/g 10237-0733-42 Church 119 g FDA listed
Orajel Toy Story 5 Anticavity 1.5 mg/g 10237-0734-42 Church 119 g FDA listed
Orajel KidsToothpaste 1.5 mg/g 10237-0785-42 Church 119 g FDA listed
Orajel Paw Patrol 1.5 mg/g 10237-0786-42 Church 119 g FDA listed
Orajel Gabbys Dollhouse 2.4 mg/g 10237-0914-42 Church 119 g FDA listed
Colgate MaxFresh with Mini Breath Clean Mint 1.1 mg/g 35000-0013-34 Colgate-Palmolive 2 tubes Discontinued
Colgate MaxFresh with Mini Breath Cool Mint 1.1 mg/g 35000-0014-34 Colgate-Palmolive 2 tubes Discontinued
Colgate Kids Cavity Protection 1.1 mg/g 35000-0015-32 Colgate-Palmolive 90 g FDA listed
Colgate Kids Harry Potter 1.1 mg/g 35000-0016-46 Colgate-Palmolive 130 g FDA listed
Colgate MaxClean with Whitening Smartfoam 1.1 mg/gthis 35000-0028-63 Colgate-Palmolive 1 tube FDA listed
Colgate MaxFresh Knockout 1.1 mg/g 35000-0127-60 COLGATE 1 tube Discontinued
Colgate MaxFresh Citrus Fresh 1.1 mg/g 35000-0137-48 Colgate-Palmolive 1 tube FDA listed
Colgate MaxFresh Watermelon Blast 1.1 mg/g 35000-0138-48 Colgate-Palmolive 1 tube FDA listed
Colgate Kids Maximum Cavity Protection 1.1 mg/g 35000-0190-44 Colgate-Palmolive 124 g FDA listed
Colgate Maximum Cavity Protection Bubble Fruit Flavor 1.1 mg/g 35000-0196-44 Colgate-Palmolive 124 g FDA listed
Colgate Kids Space Jam Mild Bubble Fruit Flavor 1.1 mg/g 35000-0199-44 Colgate-Palmolive 124 g FDA listed
Colgate MaxFresh Cool Mint 1.1 mg/g 35000-0211-30 COLGATE 1 cello FDA listed
Colgate MaxFresh Clean Mint 1.1 mg/g 35000-0212-30 Colgate-Palmolive 1 cello FDA listed
Colgate MaxFresh Charcoal 1.1 mg/g 35000-0213-95 Colgate-Palmolive 1 tube FDA listed
Colgate MaxFresh Knockout 1.1 mg/g 35000-0214-30 Colgate-Palmolive 1 cello FDA listed
Colgate Kids Llama Mild Bubble Fruit Flavor 1.1 mg/g 35000-0365-44 Colgate-Palmolive 124 g FDA listed
Colgate Ultra White Charcoal 1.1 mg/g 35000-0418-98 Colgate-Palmolive 1 tube FDA listed
TP COL OW Purple 1.1 mg/g 35000-0419-71 Colgate-Palmolive 1 tube FDA listed
Colgate MaxFresh Clean Mint 1.1 mg/g 35000-0430-58 Colgate-Palmolive 1 tube FDA listed
Hello Dragon Dazzle Dragon Dazzle Fluoride 1.5 mg/g 35000-0679-10 Colgate-Palmolive 1 tube FDA listed
Hello Magical Mermaid 1.1 mg/g 35000-0680-10 Colgate-Palmolive 119 g FDA listed
Hello Unicorn Sparkle 1.1 mg/g 35000-0686-10 Colgate-Palmolive 1 tube FDA listed
Hello Kids Wild Strawberry Wild Strawberry 1.5 mg/g 35000-0688-10 Colgate-Palmolive 1 tube FDA listed
Hello Vitamin C Whitening 1.5 mg/g 35000-0689-10 Colgate-Palmolive 1 tube FDA listed
Hello Penguin Chill 1.1 mg/g 35000-0693-12 Colgate-Palmolive 1 tube FDA listed
Colgate Max Fresh Coconut Pineapple 2.4 mg/g 35000-0789-86 Colgate-Palmolive 1 tube 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 Optic White Non-Hp Stain Fighter Fresh Mint 1.1 mg/g 35000-0797-59 Colgate-Palmolive 1 tube FDA listed
Colgate Optic White Charcoal 1.1 mg/g 35000-0798-59 Colgate-Palmolive 1 tube FDA listed
Colgate Optic White Relief 1.1 mg/g 35000-0799-59 Colgate-Palmolive 1 tube FDA listed
Colgate Optic White Stain Fighter With Baking Soda 1.1 mg/g 35000-0809-42 Colgate-Palmolive 1 tube FDA listed
Colgate Max Fresh Advanced Whitening 2.4 mg/g 35000-0899-34 Colgate-Palmolive 2 tubes Discontinued
Colgate Sparkling White Cinnamint 1.1 mg/g 35000-0900-60 Colgate-Palmolive 1 tube Discontinued
Colgate Max Fresh Cool Mint 1.1 mg/g 35000-0903-01 Colgate-Palmolive 1 tube FDA listed
Colgate Kids Watermelon Flavor 1.1 mg/g 35000-0905-81 Colgate-Palmolive 130 g FDA listed
Colgate 2In1 Whitening Stain Lifters 1.1 mg/g 35000-0907-81 Colgate-Palmolive 130 g FDA listed
Colgate Strawberry Burst 1.1 mg/g 35000-0915-46 Colgate-Palmolive 130 g FDA listed
Colgate Ultra Brite Advanced Whitening All In One Clean Mint 1.1 mg/g 35000-0917-60 Colgate-Palmolive 1 tube FDA listed
Colgate Kids Mild Bubble Fruit Flavor 1.1 mg/g 35000-0918-46 Colgate-Palmolive 130 g FDA listed
Colgate Junior Bubble Fruit 1.1 mg/g 35000-0926-20 COLGATE 1 tube Discontinued
Colgate 2In1 Icy Blast 1.1 mg/g 35000-0927-81 Colgate-Palmolive 130 g FDA listed
Colgate Optic White Stain Fighter Fresh Mint 1 mg/g 35000-0936-02 COLGATE 1 tube FDA listed
Colgate Optic White Stain Fighter Clean Mint 1 mg/g 35000-0937-02 COLGATE 1 tube FDA listed
Colgate Triple Action 1.1 mg/g 35000-0941-46 Colgate-Palmolive 1 tube 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 Cavity Protection 1.1 mg/g 35000-0953-71 Colgate-Palmolive 119 g FDA listed
Colgate Junior Mixed Kids Bubble Fruit Fluoride 1.1 mg/g 35000-0958-46 Colgate-Palmolive 130 g Discontinued
Colgate Deep Clean Fluoride 1.1 mg/g 35000-0969-58 Colgate-Palmolive 1 tube FDA listed
Colgate Minions Mild Bubble Fruit Fluoride 1.1 mg/g 35000-0971-46 Colgate-Palmolive 130 g FDA listed
Colgate Optic White Charcoal 1.1 mg/g 35000-0988-71 Colgate-Palmolive 1 tube FDA listed
Colgate MaxFresh Charcoal 1.1 mg/g 35000-0990-34 Colgate-Palmolive 2 tubes Discontinued
TP OW Stainfighter Clean Mint 1.1 mg/g 35000-0999-34 Colgate-Palmolive 1 tube FDA listed
ACT Anticavity Fluoride Kids Wild Watermelon 1.4 mg/g 41167-0924-02 Chattem, 130 g FDA listed
ACT Kids Anticavity Fluoride Groovy Grape 1.4 mg/g 41167-0926-01 Chattem, 130 g FDA listed
Beyond Activated Coconut Charcoal and Sea Salt .24 g/100g 42199-0008-04 Beyond 1 tube FDA listed
Natural Fluoride Fresh Mint cavity protection whitening fresh breath .00243 g/g 51009-0238-59 Tom's 85 g FDA listed
Simply White Clean Mint .00243 g/g 51009-0248-47 Tom's 1 tube Discontinued
Toms Of Maine Activated Charcoal Peppermint 1.1 mg/g 51009-0900-40 Tom's 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
Toms Of Maine Whiten Plus Deep Clean Spearmint 1.1 mg/g 51009-0921-40 Tom's 1 tube FDA listed
Opalescence Whitening Cool Mint 1.1 mg/g 51206-0314-01 Ultradent 1 tube FDA listed
Euthymol Whitening Purple Corrector 1.5 mg/g 53208-0563-65 LG 1 tube FDA listed
PERIOSCIENCES White Care AO Pro .24 mg/100mL 53238-0001-90 PERIOSCIENCES 1 tube FDA listed
Koala Pals Berrylicious .2592 g/108g 54473-0300-04 Melaleuca, 108 g FDA listed
OralLine Secure .15 g/100g 55873-0001-01 J.M. 85 g FDA listed
OralLine .15 g/100g 55873-0002-01 J.M. 85 g FDA listed
OralLine Kids .15 g/100g 55873-0003-01 J.M. 113.4 g FDA listed
OralLine Kids .15 g/100g 55873-0004-01 J.M. 113.4 g FDA listed
CloSYS 1.1 mg/g 58578-0749-01 Rowpar 1 tube FDA listed
Kids Kare 2.4 mg/g 59883-0718-04 DEN-MAT 113.4 g FDA listed
Gel 1100 Mint 1100 ug/g 61578-0213-01 Dental 68 g FDA listed
Gel 1100 Citrus 1100 ug/g 61578-0214-01 Dental 68 g FDA listed
Gel 1100 Grape 1100 ug/g 61578-0217-01 Dental 68 g FDA listed
MIPasteOne Kids Blue Raspberry .24 g/100g 61596-0100-10 GC 1 tube FDA listed
MIPaste One Kids Bubble Gum .24 g/100g 61596-0101-10 GC 1 tube FDA listed
MIPaste One Kids Cotton Candy .24 g/100g 61596-0102-10 GC 1 tube FDA listed
MIPaste One Kids Blue Raspberry .24 g/100g 61596-0103-10 GC 10 bottles FDA listed
Made by Dentists For Kids Cheetah Dust 1.5 mg/g 62776-0000-01 Fulijaya 1 tube FDA listed
Made by Dentists For Kids Eyeball Juice 1.5 mg/g 62776-0001-01 Fulijaya 1 tube FDA listed
Made by Dentists For Kids Monster Slime 1.5 mg/g 62776-0002-01 Fulijaya 1 tube FDA listed
Made by Dentists Ultra Whitening Professional 1.5 mg/g 62776-0005-01 Fulijaya 1 tube FDA listed
Made by Dentist For Kids Chew Toy Bubblegum 1.5 mg/g 62776-0006-01 Fulijaya 1 tube FDA listed
Colgate Sparkling White Cinnamint 1.1 mg/g 65954-0008-69 Mission 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 FDA listed
Colgate 2In1 Whitening Stain Lifters 1.1 mg/g 65954-0038-81 Mission 130 g FDA listed
Colgate Cavity Protection Fresh Mint 1.1 mg/g 65954-0061-69 Mission 113 g Discontinued
Colgate Ultra Brite Advanced Whitening All In One Clean Mint 1.1 mg/g 65954-0064-60 Mission 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 2In1 Icy Blast 1.1 mg/g 65954-0355-81 Mission 130 g FDA listed
Colgate Optic White Stain Fighter Fresh Mint 1 mg/g 65954-0402-02 Mission 1 tube FDA listed
Colgate Optic White Stain Fighter Clean Mint 1 mg/g 65954-0403-02 Mission 1 tube FDA listed
Colgate Triple Action 1.1 mg/g 65954-0536-30 Mission 3 tubes FDA listed
Colgate Max Fresh Cool Mint 1.1 mg/g 65954-0564-81 Mission 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 Junior Mixed Kids Bubble Fruit Fluoride 1.1 mg/g 65954-0607-46 Mission 1 tube FDA listed
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
TP COL OW Purple 1.1 mg/g 65954-0825-58 Mission 1 tube FDA listed
Colgate Max Fresh Clean Mint 1.1 mg/g 65954-0831-58 Colgate-Palmolive 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 Charcoal 1.1 mg/g 65954-0835-59 Mission 1 tube 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 Optic White Non-Hp Stain Fighter Clean Mint 1.1 mg/g 65954-0840-38 Mission 2 tubes FDA listed
Firefly Bubble Gum natural fluoride .24 g/100g 66923-0119-00 Ranir 119 g FDA listed
Firefly Strawberry Natural Fluoride .24 g/100g 66923-0201-00 Ranir 119 g FDA listed
Firefly Bubble Gum natural fluoride .24 g/100g 66923-0323-00 Ranir 119 g FDA listed
Pro-Sys .11 g/100g 66975-0700-01 Benco 113.4 g FDA listed
Pro-Sys .11 g/100g 66975-0720-01 Benco 113.4 g FDA listed
Quip Anticavity .24 g/100g 69261-0006-01 Quip 1 tube FDA listed
Quip Anticavity .24 g/100g 69261-0007-01 Quip 1 tube FDA listed
Crest Complete plus Whitening Deep Clean 1.5 mg/g 69423-0911-54 The 1 tube FDA listed
evo ADVANCED WHITENING ANTI-CAVITY FLUORIDE PEPPERMINT .24 g/100g 70108-0204-01 Ashtel 1 tube FDA listed
Brush Buddies ADVANCED WHITENING ANTI-CAVITY FLUORIDE PEPPERMINT .24 g/100g 70108-0205-01 Ashtel 1 tube FDA listed
Plak Smacker Anti Cavity Fluoride 1.4 mg/g 72326-8002-01 YOUNG 24 g FDA listed
Plak Smacker GREAT WHITE SHARK 1.4 mg/g 72326-8003-01 YOUNG 120 g FDA listed
Eurofresh Whitening 1.08 mg/g 74690-0008-01 Farmasi 1 tube FDA listed
Farmasi Whitening 1.5 mg/g 74690-0012-01 Farmasi 1 tube FDA listed
Made By Dentists, Inc. Whitening .24 g/100g 75065-0017-06 Made 1 tube Discontinued
Made By Dentists, Inc. Total Care .24 g/100g 75065-0018-06 Made 1 tube Discontinued
Made By Dentists, Inc. Alien Blood .24 g/100g 75065-0020-06 Made 1 tube Discontinued
Made By Dentists, Inc. Monster Slime .24 g/100g 75065-0021-06 Made 1 tube Discontinued
Made by Dentists For Kids Monster Slime Sour Apple 1.5 mg/g 75065-0023-06 MADE 1 tube FDA listed
Made by Dentists For Kids Eyeball Juice (Watermelon) 1.5 mg/g 75065-0024-06 MADE 1 tube FDA listed
Made by Dentists For Kids Cheetah Dust (Strawberry) 1.5 mg/g 75065-0025-06 MADE 1 tube FDA listed
Made by Dentists For Kids Alien Blood 1.5 mg/g 75065-0026-06 MADE 1 tube Discontinued
Made by Dentists Ultra Whitening Fresh Mint 1.5 mg/g 75065-0027-06 MADE 1 tube FDA listed
Made by Dentists For Kids Eyeball Juice (Watermelon) 1.5 mg/g 75065-0030-07 MADE 1 tube FDA listed
Made by Dentist for Kids Chew Toy (Bubblegum) 1.5 mg/g 75065-0031-06 MADE 1 tube FDA listed
Made by Dentists for Kids Fluoride Anticavity Bamboolicious (Bubblegum) 1.5 mg/g 75065-0032-06 Made 1 tube FDA listed
Freshen Up Vanilla Mint .24 g/100g 77782-0006-20 MKJ 1 bottle FDA listed
Freshen Up Holiday mint .24 g/100g 77782-0007-20 MKJ 1 bottle FDA listed
Freshen Up pepper mint .24 g/1000g 77782-0008-20 MKJ 1 bottle FDA listed
Freshen Up twisted peppermint .24 g/100g 77782-0010-20 MKJ 1 bottle FDA listed
Freshen-up Matcha Mint .24 g/100g 77782-0011-20 MKJ 1 bottle FDA listed
Freshen Up chai latte mint .24 g/1000g 77782-0012-20 MKJ 1 bottle FDA listed
Moon Platinum Advanced Whitening Anticavity .24 g/100g 82214-0001-02 Moon 1 tube FDA listed
Moon Charcoal Whitening Anticavity .24 g/100g 82214-0003-02 Moon 1 tube FDA listed
Moon Whitening Gel Anticavity .24 g/100g 82214-0004-02 Moon 1 tube FDA listed
Hismile 2.4 mg/g 83013-0311-06 Hismile 60 g FDA listed
Hismile 2.4 mg/g 83013-0312-06 Hismile 60 g FDA listed
Hismile 2.4 mg/g 83013-0313-06 Hismile 60 g FDA listed
Hismile 2.4 mg/g 83013-0314-06 Hismile 60 g FDA listed
Hismile 2.4 mg/g 83013-0315-06 Hismile 60 g FDA listed
Hismile 2.4 mg/g 83013-0316-06 Hismile 60 g FDA listed
Hismile 2.4 mg/g 83013-0317-06 Hismile 60 g FDA listed
Hismile 2.4 mg/g 83013-0318-06 Hismile 60 g FDA listed
Hismile 2.4 mg/g 83013-0319-06 Hismile 60 g FDA listed
Hismile 2.4 mg/g 83013-0320-06 Hismile 60 g FDA listed
Hismile .243 g/100g 83013-0321-06 HISMILE 60 g FDA listed
Hismile .243 g/100g 83013-0322-06 HISMILE 60 g FDA listed
Hismile .243 g/100g 83013-0323-06 HISMILE 60 g FDA listed
Hismile .243 g/100g 83013-0325-06 HISMILE 60 g FDA listed
Hismile .243 g/100g 83013-0326-06 HISMILE 60 g FDA listed
Hismile .243 g/100g 83013-0327-06 HISMILE 60 g FDA listed
Ice Pop Flavor Sodium Fluoride Anticavity Toothpast .243 g/100g 83013-0328-06 HISMILE 60 g FDA listed
Hismile Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpast .243 g/100g 83013-0331-06 Hismile 60 g FDA listed
Hismile Pink Lemonade Sodium Fluoride Anticavity Toothpast .243 g/100g 83013-0332-06 Hismile 60 g FDA listed
Hismile Miffy Sweet Apple Flavor Sodium Fluoride Anticavity Toothpast .243 g/100g 83013-0333-06 Hismile 60 g FDA listed
Hismile .243 g/100g 83013-0335-06 Hismile 60 g FDA listed
The Simpsons Purple Squishee Flavor Sodium Fluoride Anticavity Toothpast .243 g/100g 83013-0346-06 HISMILE 60 g FDA listed
Enamur Fluoride AntiCavity Toothpast 1.4 mg/g 83610-1050-01 Protegera, 1 tube FDA listed
OraPro Fluoride Anticavity 1.4 mg/g 83610-1060-01 Protegera, 1 tube FDA listed
Dubai Chocolate Flavor 2.4 mg/g 83729-0119-10 SuperMouth, 1 tube FDA listed
Super Mint .24 mg/100g 83729-0121-10 SuperMouth, 1 tube FDA listed
Dentalclean Ultra Refreshing Extreme Ice Dental Gel 2.4 mg/g 84035-0001-01 Rabbit 1 tube FDA listed
Dentalclean Regenerator Sensitive Dental Gel with Fluoride 2.4 mg/g 84035-0002-03 Rabbit 1 tube FDA listed
Dentalclean Sensitive Plus 2.4 mg/g 84035-0003-03 Rabbit 1 tube FDA listed
Dentalclean Whitening Max 2.4 mg/g 84035-0004-03 Rabbit 1 tube FDA listed
Dentalclean Regenerator Sensitive Kids 2.4 mg/g 84035-0005-03 Rabbit 1 tube FDA listed
Dentalclean Dental Gel Booster Adult Use 2.4 mg/g 84035-0006-20 Rabbit 1 tube FDA listed
Dentalclean Booster Kids 2.4 mg/g 84035-0007-20 Rabbit 1 tube FDA listed
Dentalclean Doctor Duck 2.4 mg/g 84035-0008-50 Rabbit 1 tube FDA listed
Dentalclean Advanced Pro 2.4 mg/g 84035-0013-06 Rabbit 1 tube FDA listed
Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth .1 g/100g 85162-0003-01 Yangzhou 144 tubes FDA listed
Sexyteeth Charcoal T00Thpaste .24 g/100g 85215-0003-01 WORLD 113 g FDA listed
Sexyteeth Minty T00Thpaste .24 g/100g 85215-0004-01 WORLD 113 g FDA listed
Smile Paint 87245-0001-01 JABBER 1 kit FDA listed
Sensodyne Pronamel Kids Bubble Twist 1.1 mg/g 00135-0808-01 Haleon 1 tube FDA listed
Crest Complete Multi-Benefit Plus Scope 1.1 mg/g 37000-0822-04 The 130 g FDA listed
Sensodyne Pronamel Kids Berry Twist 1.1 mg/g 00135-0809-01 Haleon 1 tube FDA listed
COLGATE MAX WHITE WITH MINI BRIGHT STRIPS Crystal MINT 1.1 mg/g 65954-0041-81 Mission 130 g 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 MAX WHITE WITH MINI BRIGHT STRIPS Crystal MINT 1.1 mg/g 35000-0908-81 Colgate-Palmolive 130 g FDA listed
Sensodyne Pronamel Kids Bubble Mint 1.1 mg/g 00135-0818-01 Haleon 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
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

🏛️
2019
On the market since
Oct 2019
📍
2026
Currently FDA-listed
7 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 MaxClean with Whitening Smartfoam (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
Life-threatening84
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 136 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
35000-0028-60 1 TUBE in 1 CARTON (35000-028-60) / 170 g in 1 TUBE 2019-10-24 Discontinued by firm
35000-0028-63 You're viewing this 1 TUBE in 1 CARTON (35000-028-63) / 178 g in 1 TUBE 2021-11-01 Active

Pack size FAQ

What quantity is in NDC 35000-0028-63?
NDC 35000-0028-63 is listed by the FDA — 1 tube in 1 carton / 178 g in 1 tube.
What NDC number is used to bill for this package of Colgate MaxClean with Whitening Smartfoam Sodium Fluoride 1.1 mg/g Paste, Dentifrice?
Bill NDC 35000-0028-63 — the 11-digit billing format is 35000002863. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

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

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 35000-028-63, 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: 35000-0028-63, written without dashes as 35000002863. 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 35000-0028-63, the first segment (35000) is the labeler code FDA assigned to Colgate-Palmolive Company; the middle segment (0028) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (63) 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 2026-12-01, 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 (35000-0028-60). 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 Fluoride 0.24% (0.14% w/v fluoride ion)

🧪 Inactive Ingredients 28 words

Inactive ingredients Water, Sorbitol, Hydrated Silica, PEG-12, Poloxamer 407, Sodium Lauryl Sulfate, Flavor, Xanthan Gum, Cocamidopropyl Betaine, Tetrasodium Pyrophosphate Sodium Saccharin, Mica, Hydroxypropyl Methylcellulose, Blue 1, Titanium Dioxide.

🎯 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 ↗
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.