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TheraBreath Fresh Breath Anticavity Mild Mint Sodium Fluoride .24 g/100g Paste, Dentifrice, 1 tube — NDC 10237-0263-04 package photo

TheraBreath Fresh Breath Anticavity Mild Mint Sodium Fluoride .24 g/100g Paste, Dentifrice, 1 tube

by Church & Dwight Co., Inc. · 1 TUBE in 1 CARTON (10237-263-04) / 113.5 g in 1 TUBE
NDC 10237-0263-04
🏷️ FDA NDC (as labeled) 10237-263-04 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) 10237-263-04
Product NDC 10237-263
11-digit billing NDC 10237026304
RxCUI 416783
UNII 8ZYQ1474W7
UPC 0697029211045
Application # M021
SPL Set ID 19ce5324-7d8d-4d70-ad9b-238f7e612eac
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-02-08
Route ORAL
Dosage form PASTE, DENTIFRICE
Substance SODIUM FLUORIDE
Why two NDCs? The FDA registers this code as 10237-263-04 — 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 → 10237-0263-04. 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

LabelerChurch & Dwight Co., Inc.
FDA applicationM021 (OTC MONOGRAPH DRUG)
Labeler code10237
First marketedFeb 2024
Product typeHuman Otc Drug
Portfolio144 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?

TheraBreath Fresh Breath is an over-the-counter toothpaste containing sodium fluoride, which is typically used in dental products to help strengthen tooth enamel and reduce cavity formation. This product is marketed as an OTC monograph drug, meaning it follows established FDA guidelines for anticavity toothpastes rather than undergoing individual drug review. The paste is applied topically to the teeth and gums during regular brushing.

Supplement & herbal interactions

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

💊 What it looks like

FlavorMint
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

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

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII 3VRD35U26C
    A natural extract from licorice root, ammonium glycyrrhizate is used as a flavoring agent and sweetener in medicines. It may also help soothe irritated tissues in the mouth or throat.
  • UNII PQ6CK8PD0R
    Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
  • UNII K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • 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 B9W4019H5G
    Tetrapotassium pyrophosphate is a mineral salt used as a buffering agent and emulsifier in medicines. It helps stabilize formulations and maintain proper pH levels.
  • 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 G538EBV4VF
    Sodium chlorite is a white crystalline salt used as a preservative and antimicrobial agent in medications. It helps prevent bacterial and fungal growth to maintain product stability during storage.
  • UNII O352864B8Z
    A sodium salt compound used in medicines as a buffering agent to maintain pH stability and as a chelating agent to prevent unwanted chemical reactions during storage and mixing.
  • UNII 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 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 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.

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

The official label also statesSorbitol, Water, Hydrated Silica, Glycerin, Xylitol, Natural Flavors, Cellulose Gum, Tetrapotassium Pyrophosphate, Tetrasodium Pyrophosphate, Ammonium Glycyrrhizate, Sodium Benzoate, Citric Acid, Sodium Chlorite, Aloe Barbadensis Leaf Juice, Ascorbic Acid (Vitamin C).

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
BIOTENE Gentle Mint 1.5 mg/g 00135-0558-01 Haleon 1 tube — — FDA listed —
TheraBreath Fresh Breath Anticavity Mild Mint .24 g/100gthis 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 — — 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 —
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
Feb 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 TheraBreath Fresh Breath Anticavity Mild Mint (this brand).

Top reported reactions

Pyrexia172
Weight Increased162
Nausea160
Vomiting159
Fatigue158
Pain158
Nasopharyngitis155

Reporter sex

1,067 reports

Serious outcomes

Hospitalization379
Life-threatening84
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 213 43
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
10237-0263-04 You're viewing this 1 TUBE in 1 CARTON (10237-263-04) / 113.5 g in 1 TUBE 2024-02-08 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 10237-263-04, 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: 10237-0263-04, written without dashes as 10237026304. 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 10237-0263-04, the first segment (10237) is the labeler code FDA assigned to Church & Dwight Co., Inc.; the middle segment (0263) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 Church & Dwight Co., Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Church & Dwight Co., 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 8 words ▾

Uses Aids in the prevention of dental decay.

⏱️ Dosage and Administration 86 words ▾

Directions Do not swallow. Supervise children as necessary until capable of using without supervision. Adults and children 6 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 doctor.

Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Do not use unless directed by a dentist or doctor.

⚠️ 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.

📦 Storage and Handling 26 words ▾

Other information If spilled on fabrics, wash out immediately. This product was sealed with protective packaging at the laboratory. If seal is missing, do not use.

🧪 Active Ingredient 9 words ▾

Active Ingredients Sodium fluoride 0.24% (0.14% W/V fluoride ion)

🧪 Inactive Ingredients 32 words ▾

Inactive Ingredients Sorbitol, Water, Hydrated Silica, Glycerin, Xylitol, Natural Flavors, Cellulose Gum, Tetrapotassium Pyrophosphate, Tetrasodium Pyrophosphate, Ammonium Glycyrrhizate, Sodium Benzoate, Citric Acid, Sodium Chlorite, Aloe Barbadensis Leaf Juice, Ascorbic Acid (Vitamin C).

🎯 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 ↗
← 10237-0262-16 · Church 10237-0265-01 · Church →
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.