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SmileSense Stannous Fluoride .11 g/100g Paste, Dentifrice, 108 g — NDC 72644-0639-01 package photo

SmileSense Stannous Fluoride .11 g/100g Paste, Dentifrice, 108 g

by SGII, INC · 108 g in 1 TUBE (72644-639-01)
NDC 72644-0639-01
🏷️ FDA NDC (as labeled) 72644-639-01 billing pads the product segment with a zero
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) 72644-639-01
Product NDC 72644-639
11-digit billing NDC 72644063901
RxCUI 416784
UNII 3FTR44B32Q
Application # M021
SPL Set ID 1c371393-da75-c9c8-e063-6294a90a5840
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-07-01
Route DENTAL
Dosage form PASTE, DENTIFRICE
Substance STANNOUS FLUORIDE
Why two NDCs? The FDA registers this code as 72644-639-01 — 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 → 72644-0639-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Caries prophylactic agents class.

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

🏭 Manufacturer & labeler

LabelerSGII, INC
FDA applicationM021 (OTC MONOGRAPH DRUG)
Labeler code72644
First marketedJul 2024
Product typeHuman Otc Drug
Portfolio2 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

📖 About the active ingredient: Stannous Fluoride MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usually is prescribed for children and adults whose homes have water that is not fluoridated (already has fluoride added). This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗
🧪 What is this product?

SmileSense Stannous Fluoride is a fluoride toothpaste regulated as an over-the-counter monograph drug. Stannous fluoride is a mineral compound commonly used in dental care products to help strengthen tooth enamel and reduce cavity formation. This paste is applied topically to the teeth during brushing as part of regular oral hygiene.

Supplement & herbal interactions

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

🧪 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 4YGF4PQP49
    A natural plant oil compound used as a flavoring agent and fragrance in medicines. It contributes taste and aroma to make the medication more pleasant.
  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 142M471B3J
    Carbon dioxide is a colorless gas used in medicines as a propellant in pressurized inhalers and aerosol sprays to help deliver the active medication to where it's needed.
  • UNII 4RWC1CMS3X
    A natural compound derived from caraway and spearmint plants. It serves as a flavoring agent to improve taste and may help mask bitter flavors in medicines.
  • UNII RA96B954X6
    Erythritol is a sugar alcohol derived from fermented fruits or grains. It's used as a sweetener and bulking agent in medicines to improve taste without adding significant calories.
  • UNII 0PK353KHF0
    A plant extract from gardenia flowers used as a natural colorant and flavor ingredient in medicines. It helps give the medication its color and taste.
  • UNII 6FO62043WK
    Glycyrrhizin is a natural compound extracted from licorice root. It's used in medicines as a sweetener, flavoring agent, and to help soothe irritated mucous membranes in throat lozenges and cough products.
  • UNII Y6O7T4G8P9
    Hydrated silica is a fine powder form of silicon dioxide with absorbed water. It works as an anti-caking agent and absorbent in medicines, helping powders stay free-flowing and preventing clumping.
  • UNII S870P55O2W
    Isomalt is a sugar alcohol made from sugar that's used as a sweetener and bulking agent in medicines. It helps give tablets and powders the right texture and sweetness while having minimal calories.
  • UNII GFD7C86Q1W
    A natural oil extracted from citrus peels, (+)-limonene is used as a flavoring agent and solvent in medicines. It helps dissolve active ingredients and provides a lemon or orange taste.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII L7T10EIP3A
    A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
  • UNII AV092KU4JH
    A natural oil extracted from peppermint plants. It's used as a flavoring agent to mask bitter tastes and add a refreshing mint flavor to medicines, making them easier to take.
  • UNII 7YC686GQ8F
    A synthetic oily substance made from castor oil. It works as a solubilizer and emulsifier to help mix oily and water-based ingredients together in the medicine.
  • UNII NPT6P8P3UU
    Potassium bitartrate is a naturally derived salt compound used in medicines as a buffer and pH regulator. It helps maintain the acidity level of a formulation to keep the drug stable and effective.
  • UNII EE90ONI6FF
    Potassium citrate is a salt derived from citric acid and potassium. In medicines, it acts as a buffer to adjust and maintain the pH balance of the product, helping keep it stable and palatable.
  • UNII B3FUD0528F
    Rebaudioside A is a naturally derived sweetener extracted from stevia leaves. It sweetens the medicine without adding calories and helps mask bitter tastes to improve how the medication goes down.
  • 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 NOU2FB51TW
    A natural sweetener extracted from monk fruit, a plant grown in Southeast Asia. It sweetens the medicine while adding minimal calories and helps improve taste.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 8MDF5V39QO
    A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 632GS99618
    Sodium lauroyl sarcosinate is a mild, plant-derived cleaning agent used in medicines as a surfactant and emulsifier. It helps mix oil and water-based ingredients and may aid tablet disintegration.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII C3M81465G5
    Spearmint oil is a natural flavoring extract from spearmint plants. It's added to medicines to improve taste and mask bitter flavors, making medications easier to take.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
  • UNII VCQ006KQ1E
    Xylitol is a naturally occurring sugar alcohol derived from plants. It's used in medicines as a sweetener, bulking agent, and to improve taste, especially in liquid formulations and chewable tablets.
  • UNII K72I3DEX9B
    Zinc citrate is a zinc salt combined with citric acid. It's used in medicines as a source of zinc and sometimes as a buffer to help maintain the product's pH balance.

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

The official label also statesCaprylic/Capric Triglyceride (Organic Coconut Oil), Isomalt, Hydrated Silica, Xylitol, Sorbitol, Sodium Bicarbonate, Erythritol, Sodium Lauroyl Sarcosinate, Flavor, Xanthan Gum, Menthol, PEG-40 Hydrogenated Castor Oil, Zinc Citrate, Mentha Piperita (Peppermint) Oil, Mentha Viridis (Spearmint) Leaf Oil, Potassium Citrate, Siraitia Grosvenorii (Monkfruit) Fruit Extract, Sodium Saccharin, Potassium Bitartrate, Carbon Dioxide, Sodium Benzoate, Water, Maltodextrin, Carvone, Rebaudioside A, Alcohol Denat., Limonene, Sodium Chloride, Hydrolyzed Gardenia Florida Extract, Glycyrrhizic Acid, Gamma-Terpinene, Titanium Dioxide.

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

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

Inactive ingredient FAQ

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

💲 Pricing

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

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

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
SENSODYNE Repair and Protect Extra Fresh 1.1 mg/g 00135-0547-02 Haleon 1 tube — — FDA listed —
SENSODYNE Repair and Protect 1.1 mg/g 00135-0548-01 Haleon 1 tube — — FDA listed —
Sensodyne Complete Protection Extra Fresh 1.1 mg/g 00135-0572-02 Haleon 1 tube — — FDA listed —
Sensodyne Complete Protection 1.1 mg/g 00135-0573-02 Haleon 1 tube — — FDA listed —
SENSODYNE Repair and Protect Whitening 1.1 mg/g 00135-0575-01 Haleon 1 tube — — FDA listed —
parodontax 1.1 mg/g 00135-0598-01 Haleon 1 tube — — FDA listed —
parodontax 1.1 mg/g 00135-0601-01 Haleon 1 tube — — FDA listed —
SENSODYNE Rapid Relief 1.1 mg/g 00135-0621-01 Haleon 1 tube — — FDA listed —
SENSODYNE Rapid Relief 1.1 mg/g 00135-0622-01 Haleon 1 tube — — FDA listed —
parodontax Complete Protection 1.1 mg/g 00135-0627-01 Haleon 1 tube — — FDA listed —
SENSODYNE Rapid Relief 1.1 mg/g 00135-0632-01 Haleon 1 tube — — FDA listed —
parodontax Complete Protection 1.1 mg/g 00135-0634-01 Haleon 1 tube — — FDA listed —
parodontax Active Gum Repair 1.1 mg/g 00135-0637-01 Haleon 1 tube — — FDA listed —
parodontax Active Gum Repair Whitening 1.1 mg/g 00135-0638-03 Haleon 1 tube — — FDA listed —
Parodontax Gum Strengthen and Protect 1.5 mg/g 00135-0655-01 Haleon 1 tube — — FDA listed —
Polident ProPartial 1.5 mg/g 00135-0710-01 Haleon 1 tube — — FDA listed —
parodontax Active Gum Repair Breath Freshener 1.1 mg/g 00135-0737-01 Haleon 1 tube — — FDA listed —
SENSODYNE Sensitivity Gum and Enamel Mint 1.1 mg/g 00135-5022-01 Haleon 1 tube — — FDA listed —
SENSODYNE Sensitivity and Gum Mint 1.1 mg/g 00135-5023-01 Haleon 1 tube — — FDA listed —
SENSODYNE Sensitivity and Gum Whitening 1.1 mg/g 00135-5024-01 Haleon 1 tube — — FDA listed —
Sensodyne Sensitivity And Gum Clean And Fresh 1.1 mg/g 00135-5025-01 Haleon 1 tube — — FDA listed —
Sensodyne Fresh Clean 15 mg/g 00135-5912-01 Haleon 1 tube — — FDA listed —
Sensodyne Whiten and Shine 15 mg/g 00135-5913-01 Haleon 1 tube — — FDA listed —
Walgreens Restore and Defend .15 g/100g 00363-1599-09 Walgreens 1 tube — — FDA listed —
Therabreath Deep Clean .454 g/100g 10237-0270-04 Church 1 tube — — FDA listed —
Therabreath Healthy Gums .454 g/100g 10237-0271-04 Church 1 tube — — FDA listed —
Complete Protection .15 g/100g 11673-0366-09 Target 1 tube — — FDA listed —
Complete Protection TP .15 g/100g 11822-5005-09 Rite 1 tube — — FDA listed —
Gum Detoxify .14 g/100g 11822-5006-09 Rite 1 tube — — FDA listed —
Rite Aid Sensitivity and Gum .15 g/100g 11822-5060-09 Rite 1 tube — — FDA listed —
Rite Aid Sensitive Rapid Protection .15 g/100g 11822-6031-09 Rite 1 tube — — FDA listed —
Restore and Defend Whitening TP .15 g/100g 30142-0256-01 Kroger 1 tube — — FDA listed —
Colgate Total SF Advanced Deep Clean 1.1 mg/g 35000-0169-25 Colgate-Palmolive 1 tube — — Discontinued —
Colgate Total SF Clean Mint 1.1 mg/g 35000-0172-14 Colgate-Palmolive 1 tube — — Discontinued —
Colgate Total SF Mint Stripe Gel 1.1 mg/g 35000-0174-32 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Total SF Whitening Gel 1.1 mg/g 35000-0175-32 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Total SF Whitening 1.1 mg/g 35000-0176-14 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Total SF Advanced Whitening 1.1 mg/g 35000-0178-14 Colgate-Palmolive 1 tube — — Discontinued —
Colgate Total Whitening Fresh Boost 1.1 mg/g 35000-0179-48 Colgate-Palmolive 1 tube — — Discontinued —
Colgate Total Plaque Pro Release Fresh Mint 1.1 mg/g 35000-0180-63 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Total Plaque Pro Release Whitening 1.1 mg/g 35000-0181-63 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Total SF Deep Clean 1.1 mg/g 35000-0270-32 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Total SF Advanced Whitening 1.1 mg/g 35000-0271-18 Colgate-Palmolive 1 cello — — FDA listed —
Colgate Total SF Clean Mint 1.1 mg/g 35000-0272-21 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Total SF Fresh Mint Stripe 1.1 mg/g 35000-0273-32 COLGATE 1 tube — — FDA listed —
Colgate Total SF Whitening 1.1 mg/g 35000-0274-14 COLGATE 1 tube — — FDA listed —
Colgate Total SF Whitening 1.1 mg/g 35000-0275-32 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Total SF Whitening Charcoal 1.1 mg/g 35000-0276-47 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Total Gum Protect Whitening 1.1 mg/g 35000-0277-63 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Total Gum Protect Fresh Mint 1.1 mg/g 35000-0278-63 COLGATE 1 tube — — FDA listed —
Colgate Total Plaque Cleanse 1.1 mg/g 35000-0282-63 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Total Sensitivity Mineral Shield 1.1 mg/g 35000-0283-63 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Total Enamel Strength 1.1 mg/g 35000-0284-63 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Total Active Prevention Clean Mint 1.1 mg/g 35000-0431-25 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Total Whitening Charcoal 1.1 mg/g 35000-0571-32 Colgate-Palmolive 1 tube — — FDA listed —
Hello Mighty Multi tasker 1.1 mg/g 35000-0681-10 Colgate-Palmolive 1 tube — — FDA listed —
Sensitive Whitening Anticavity .15 g/100g 36800-0201-19 Topco 1 tube — — FDA listed —
Crest 3D White Brilliance Daily Cleansing and Whitening System 37000-0863-04 The 1 kit — — FDA listed —
Crest Premium Plus Anti-Bacterial 1.4 mg/g 37000-0992-70 The 1 tube — — FDA listed —
H E B Restore and Defend .15 g/100g 37808-0230-09 HEB 1 tube — — FDA listed —
Meijer Restore and Defend Sensitive .15 g/100g 41250-0530-19 Meijer 1 tube — — FDA listed —
Care One Restore and Defend Sensitive Whitening .15 g/100g 41520-0722-19 Foodhold 1 tube — — FDA listed —
PERIOE POP Sensitivity Care Prebiotic Clean Mint 1.4 mg/g 43136-0601-01 Tai 1 tube — — FDA listed —
PERIOE Microbiome Sensitive Clean Mint 1.4 mg/g 43136-0830-01 Tai 1 tube — — FDA listed —
Enamelon .00454 g/g 48783-0520-08 Premier 1 tube — — FDA listed —
Gum Detoxify .15 g/100g 49035-0174-10 Walmart 1 tube — — FDA listed —
Opal by Opalescence Complete 1.1 mg/g 51206-0313-01 Ultradent 1 tube — — FDA listed —
Sensitivity and Gum .15 g/100g 55910-0569-19 DG 1 tube — — FDA listed —
Rexall Restore and Defend Sensitive Whitening 4.54 mg/g 55910-0820-01 Old 1 tube — — FDA listed —
MIPaste One Perio .454 g/100g 61596-0300-10 GC 10 bottles — — FDA listed —
Natural White Sensitivity and Gum .15 g/100g 62721-0003-01 Lornamead 1 tube — — FDA listed —
Total Tp Clean Mint Pst 1.1 mg/g 65954-0833-25 Mission 1 tube — — FDA listed —
Colgate Total SF Clean Mint 1.1 mg/g 67751-0224-01 Navajo 1 tube — — FDA listed —
Crest Pro-Health Densify Sensitive Care 1.5 mg/g 69423-0753-41 The 1 tube — — FDA listed —
Crest Pro-Health Densify Active Repair 1.5 mg/g 69423-0754-35 The 1 tube — — FDA listed —
Crest Pro-Health Densify Pro Intensive Repair 1.5 mg/g 69423-0755-25 The 1 tube — — FDA listed —
Crest Pro-health Gum Detoxify Deep Clean 1.5 mg/g 69423-0756-26 The 1 tube — — FDA listed —
Crest Pro-health Gum Detoxify Deep Clean 1.5 mg/g 69423-0757-37 The 1 tube — — FDA listed —
Crest Pro-Health Gum Detoxify Gentle Whitening 1.5 mg/g 69423-0758-37 The 1 tube — — FDA listed —
Crest Pro Health Enamel Repair and Gum Intensive Clean 1.5 mg/g 69423-0761-37 The 1 tube — — FDA listed —
Crest Pro Health Gum Detoxify and Restore Pro Deep Clean 1.5 mg/g 69423-0763-25 The 1 tube — — FDA listed —
Crest Pro Health Gum Detoxify and Restore Pro Whitening 1.5 mg/g 69423-0764-35 The 1 tube — — FDA listed —
Crest Pro-Health Sensitive and Gum All Day Protection 1.5 mg/g 69423-0765-16 The 1 cello — — Discontinued —
Crest Pro Health Enamel Repair and Gum Advanced Whitening 1.5 mg/g 69423-0766-26 The 1 tube — — FDA listed —
Crest Pro Health Clean Mint 1.5 mg/g 69423-0781-43 The 1 tube — — FDA listed —
Crest Pro Health Clean and Free 1.5 mg/g 69423-0782-43 The 1 tube — — FDA listed —
Crest Pro Health Sensitive and Enamel Shield 1.5 mg/g 69423-0783-26 The 1 tube — — FDA listed —
Crest Pro Health with a Touch of Scope 1.5 mg/g 69423-0784-43 The 1 tube — — FDA listed —
Crest Pro Health Whitening Gel 1.5 mg/g 69423-0786-43 The 1 tube — — FDA listed —
Crest Pro Health Advanced Antibacterial Protection 1.4 mg/g 69423-0857-50 The 1 tube — — FDA listed —
Crest Pro Health Advanced Whitening Charcoal 1.4 mg/g 69423-0860-46 The 1 tube — — FDA listed —
Crest Pro Health Advanced Whitening Intensive Cleaning 1.4 mg/g 69423-0861-58 The 1 tube — — FDA listed —
KIDS Crest Advanced Enamel Plus Cavity Protection 1.5 mg/g 69423-0862-41 The 1 tube — — FDA listed —
Crest Pro Health Advanced Gum Protection 1.6 mg/g 69423-0867-35 The 1 tube — — FDA listed —
Crest Pro Health Advanced Sensitive Relief 1.6 mg/g 69423-0868-10 The 1 cello — — Discontinued —
Crest Pro Health Advanced Deep Clean Mint 1.6 mg/g 69423-0869-35 The 1 tube — — FDA listed —
Crest Densify Daily Protection 1.5 mg/g 69423-0873-41 The 1 tube — — FDA listed —
Crest Densify Daily Whitening 1.5 mg/g 69423-0875-41 The 1 tube — — FDA listed —
Crest Pro Health Advanced Enamel Restore 1.6 mg/g 69423-0877-51 The 1 tube — — FDA listed —
Crest Braces Care Cavity Protection 1.4 mg/g 69423-0879-46 The 1 tube — — Discontinued —
Crest Premium Plus Breath Bacteria Blast 1.4 mg/g 69423-0912-52 The 1 tube — — FDA listed —
Crest Pro-Health Advanced Gum Restore Deep Clean 1.4 mg/g 69423-0925-27 The 1 tube — — FDA listed —
Crest Pro-Health Advanced Gum Restore Whitening 1.4 mg/g 69423-0926-37 The 1 tube — — FDA listed —
Crest Pro Health Breath Purify and Gum Deep Clean 1.4 mg/g 69423-0935-41 The 1 tube — — FDA listed —
Crest Pro-Health Advanced Extra Whitening 1.6 mg/g 69423-0938-35 The 1 tube — — FDA listed —
Crest Pro-Health Gum Detoxify Ultra 1.4 mg/g 69423-0952-52 The 1 tube — — FDA listed —
Crest Pro-Health Bacteria Shield and Gum Deep Clean 1.4 mg/g 69423-0956-41 The 1 tube — — Discontinued —
CVS Restore and Defend Sensitive Whitening .454 g/100g 69842-0218-19 CVS 1 tube — — FDA listed —
CVS Pharmacy Restore and Defend .15 g/100g 69842-0251-19 CVS 1 tube — — FDA listed —
CVS Rapid Protection Sensitive .15 g/100g 69842-0252-19 CVS 1 tube — — FDA listed —
CVS Complete Protection .15 g/100g 69842-0549-99 CVS 1 tube — — FDA listed —
CVS Sens Whtng .15 g/100g 69842-0563-39 CVS 1 tube — — FDA listed —
Gum Detoxify .14 g/100g 69842-0948-89 CVS 1 tube — — FDA listed —
Aru Gum Health .11 g/100g 70108-0288-01 Ashtel 1 tube — — FDA listed —
Curodont Protect .14 g/100g 72247-0107-10 CREDENTIS 10 tubes — — FDA listed —
SmileSense .11 g/100gthis 72644-0639-01 SGII, 108 g — — FDA listed —
Gum Detoxify .14 g/100g 79481-0121-09 Meijer, 1 tube — — FDA listed —
Gum Detoxify .14 g/100g 79903-0025-59 Walmart 116 g — — FDA listed —
Equate Repair and Protect .15 g/100g 79903-0082-29 Walmart 1 tube — — FDA listed —
Equate Optimal Care TP Equate Optimal Care TP .16 g/100g 79903-0280-63 Walmart 1 tube — — FDA listed —
Equate Pro-Advanced TP Equate Pro-Advanced TP .16 g/100g 79903-0281-70 Walmart 1 tube — — FDA listed —
Crest Pro-Health Maximum Cavity Protection 1.5 mg/g 84126-0608-03 The 3 tubes — — FDA listed —
Crest Pro-Health Gum Rescue Pro Soothing Clean 1.5 mg/g 84126-0609-46 The 1 tube — — FDA listed —
KIDS Crest Advanced Sugar and Bacteria Shield 1.5 mg/g 84126-0612-03 The 1 cello — — FDA listed —
Crest Pro-Health Gum Detoxify Plus 1.5 mg/g 84126-0613-45 The 1 tube — — FDA listed —
Crest Pro Health Peppermint Frost 1.5 mg/g 84126-0618-43 The 1 tube — — FDA listed —
Crest Snowberry 1.5 mg/g 84126-0619-41 The 1 tube — — FDA listed —
Crest Pro-Health Gum Recession 1.5 mg/g 84126-0623-06 The 6 tubes — — FDA listed —
Crest Pro-Health Advanced Max Cavity and Erosion Prevention 1.5 mg/g 84126-0624-02 The 1 cello — — FDA listed —
Crest Clean Breath Spearmint 1.5 mg/g 84126-0627-03 The 1 cello — — FDA listed —
Crest Pro-Health Advanced Bacteria Protection 1.4 mg/g 84126-0638-05 The 2 tubes — — FDA listed —
Crest Clean Breath Peppermint 1.5 mg/g 84126-0641-25 The 1 tube — — FDA listed —
Crest Clean Breath Spearmint 1.5 mg/g 84126-0642-03 The 1 cello — — FDA listed —
Crest Clean Breath Smooth Mint 1.5 mg/g 84126-0643-03 The 3 tubes — — FDA listed —
Crest Pro Health Advanced Protection 1.4 mg/g 84126-0657-58 The 1 tube — — FDA listed —
Livfresh Gum Protect 4.54 mg/g 87398-0001-01 Livionex 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
Jul 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 Stannous Fluoride — the ingredient across all brands.

Top reported reactions

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

Age at onset

Child1
Adolescent1
Adult15
Elderly12

Reporter sex

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

Serious outcomes

Hospitalization58
Disabling23
Death15
Life-threatening9
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 267 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
72644-0639-01 You're viewing this 108 g in 1 TUBE (72644-639-01) 2024-07-01 Active

🧭 About this NDC listing & data coverage

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

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 72644-639-01, 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: 72644-0639-01, written without dashes as 72644063901. 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 72644-0639-01, the first segment (72644) is the labeler code FDA assigned to SGII, INC; the middle segment (0639) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 SGII, INC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
SGII, INC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 37 words ▾

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

⏱️ Dosage and Administration 129 words ▾

Directions Adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush. In the AM & PM, for up to 2 minutes, gently brush your teeth using small, circular motions or as recommended by a dentist or doctor. Work your way slowly around your mouth, addressing every area of the teeth (outer, inside & chewing surface) including all sensitive areas.

Open wide and angle your toothbrush toward the gum line. Rinse your mouth & toothbrush. With fresh toothpaste, brush the surface of your tongue, with reaching as far as comfortable into your mouth.

Rinse again. Follow-up by flossing between all your teeth at least once a day. Do not swallow children under 12 yeasr: ask a dentist

⚠️ Warnings 118 words ▾

Warnings When using this product, do not use for sensitivity longer than four weeks unless recommended by a dentist. Stop use and ask a dentist if the sensitivity problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care. gingivitis, bleeding, or redness persists for more than 2 weeks. you have painful or swollen gums, pus from the gum line, loose teeth, or increased spacing between the teeth.

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

📦 Storage and Handling 33 words ▾

Other information Products containing stannous fluoride may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains, which are not harmful or permanent and may be removed by your dentist.

🧪 Active Ingredient 9 words ▾

Active ingredient Stannous Fluoride 0.454% (0.18% W/V Fluoride Ion)

🧪 Inactive Ingredients 71 words ▾

Inactive ingredients Caprylic/Capric Triglyceride (Organic Coconut Oil), Isomalt, Hydrated Silica, Xylitol, Sorbitol, Sodium Bicarbonate, Erythritol, Sodium Lauroyl Sarcosinate, Flavor, Xanthan Gum, Menthol, PEG-40 Hydrogenated Castor Oil, Zinc Citrate, Mentha Piperita (Peppermint) Oil, Mentha Viridis (Spearmint) Leaf Oil, Potassium Citrate, Siraitia Grosvenorii (Monkfruit) Fruit Extract, Sodium Saccharin, Potassium Bitartrate, Carbon Dioxide, Sodium Benzoate, Water, Maltodextrin, Carvone, Rebaudioside A, Alcohol Denat., Limonene, Sodium Chloride, Hydrolyzed Gardenia Florida Extract, Glycyrrhizic Acid, Gamma-Terpinene, Titanium Dioxide.

🎯 Purpose 10 words ▾

Purpose Stannous Fluoride 0.454% (0.18% W/V Fluoride Ion).................Anticavity, Antigingivitis, Antisensitivity

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 72644-0638-01 · SGII, 72647-0330-01 · OAKRUM →
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.