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Colgate Max Fresh Clean Mint Sodium Fluoride 1.1 mg/g Gel, Dentifrice

by Colgate-Palmolive Company · 1 TUBE in 1 CARTON (65954-831-58) / 70 g in 1 TUBE
NDC 65954-0831-58
🏷️ FDA NDC (as labeled) 65954-831-58 billing pads the product segment with a zero
This package
Contains70 g in 1 tube Pack sizes3 compare ↓
Also comes in: 179 g 65954-0831-95 53.8 g 65954-0831-99
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 →

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) 65954-831-58
Product NDC 65954-831
11-digit billing NDC 65954083158
RxCUI 416783
UNII 8ZYQ1474W7
Application # M021
SPL Set ID 3302bf2f-9f6b-4108-b64c-0928f8bfdd86
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-05-28
Route DENTAL
Dosage form GEL, DENTIFRICE
Substance SODIUM FLUORIDE
Why two NDCs? The FDA registers this code as 65954-831-58 — 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 → 65954-0831-58. 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 code65954
First marketedMay 2024
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 Max Fresh Clean Mint is a toothpaste gel sold over the counter for dental use. It contains sodium fluoride, a mineral that is commonly used in toothpastes to help strengthen tooth enamel and reduce cavity formation. This product is marketed as an over-the-counter monograph drug, meaning it follows established FDA guidelines for toothpaste ingredients rather than being approved through an individual drug application.

Supplement & herbal interactions

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

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

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: 179 g 53.8 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/g 35000-0028-60 Colgate-Palmolive 1 tube — — Discontinued —
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 — — Discontinued —
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 — — Discontinued —
Colgate 2In1 Whitening Stain Lifters 1.1 mg/g 35000-0907-81 Colgate-Palmolive 130 g — — Discontinued —
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 — — Discontinued —
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 — — Discontinued —
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 — — Discontinued —
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/gthis 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 — — Discontinued —
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 — — Discontinued —
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 —
Colgate 2In1 Whitening With Stain Lifters 1.1 mg/g 35000-0076-81 Colgate-Palmolive 130 g — — FDA listed —
Colgate Optic White Stain Fighter Clean Mint 1.1 mg/g 35000-0287-02 Colgate-Palmolive 1 tube — — FDA listed —
Opalescence Whitening Original Cool Mint Cool Mint 1.1 mg/g 51206-0450-01 Ultradent 1 tube — — FDA listed —
Colgate Watermelon Burst 1.1 mg/g 35000-0070-81 Colgate-Palmolive 130 g — — FDA listed —
Colgate Optic White Stain Fighter Fresh Mint 1.1 mg/g 35000-0288-02 Colgate-Palmolive 1 tube — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2024
On the market since
May 2024
📍
2026
Currently FDA-listed
2 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 Sodium Fluoride — the ingredient across all brands.

Top reported reactions

Fatigue367
Nausea343
Pain305
Diarrhoea300
Vomiting263
Pneumonia246
Dizziness244

Age at onset

Infant5
Child31
Adolescent20
Adult287
Elderly246

Reporter sex

4,794 reports
Male · 35%
Female · 65%
Unknown · 0%

Serious outcomes

Hospitalization1,047
Death521
Disabling166
Life-threatening156
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 760 107
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
65954-0831-58 You're viewing this 1 TUBE in 1 CARTON (65954-831-58) / 70 g in 1 TUBE 2024-05-28 Active
65954-0831-95 1 TUBE in 1 CARTON (65954-831-95) / 179 g in 1 TUBE 2024-06-17 Active
65954-0831-99 1 TUBE in 1 CARTON (65954-831-99) / 53.8 g in 1 TUBE 2025-08-01 Active

Pack size FAQ

What quantity is in NDC 65954-0831-58?
NDC 65954-0831-58 is listed by the FDA — 1 tube in 1 carton / 70 g in 1 tube.
What NDC number is used to bill for this package of Colgate Max Fresh Clean Mint Sodium Fluoride 1.1 mg/g Gel, Dentifrice?
Bill NDC 65954-0831-58 — the 11-digit billing format is 65954083158. 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 — Not published for this NDC No photo available yet for this listing.
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 65954-831-58, 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: 65954-0831-58, written without dashes as 65954083158. 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 65954-0831-58, the first segment (65954) is the labeler code FDA assigned to Colgate-Palmolive Company; the middle segment (0831) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (58) 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 2 other package presentations of this same product, including 1 tube (65954-0831-95), 1 tube (65954-0831-99). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Colgate-Palmolive Company is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 5 words ▾

Use helps protect against cavities

⏱️ Dosage and Administration 60 words ▾

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

⚠️ Warnings 32 words ▾

Warnings Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 9 words ▾

Active ingredient Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

🧪 Inactive Ingredients 27 words ▾

Inactive ingredients Sorbitol, Water, Hydrated Silica, PEG-12, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Tetrasodium Pyrophosphate, Cocamidopropyl Betaine, Sodium Saccharin, Hydroxypropyl Methylcellulose, Blue 1, Titanium Dioxide, Yellow 5.

🎯 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 ↗
← 65954-0825-58 · Mission 65954-0832-46 · Mission →
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.