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Simply White

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Active ingredient
Sodium Fluoride 0.00243 g/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2011
Label revision date
November 13, 2025
Active ingredient
Sodium Fluoride 0.00243 g/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2011
Label revision date
November 13, 2025
Manufacturer
Tom's of Maine, Inc.
Registration number
M021
NDC root
51009-248

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Drug Overview

Tom's of Maine Simply White Anticavity Toothpaste is a natural toothpaste that contains fluoride, designed to help protect against cavities while also providing clinically proven whitening benefits. With a refreshing clean mint flavor, this toothpaste not only helps to remineralize enamel but also supports overall dental health.

Accepted by the American Dental Association (ADA), this toothpaste is made without artificial flavors, sweeteners, or dyes, and it is not tested on animals, making it a thoughtful choice for those looking for a more natural oral care option.

Uses

Using this toothpaste can be a great way to help protect your teeth from cavities. It acts as an anticavity agent, meaning it works to prevent the formation of cavities and keeps your smile healthy.

One of the key benefits of this toothpaste is its ability to remineralize enamel, which is the hard outer layer of your teeth. By strengthening this layer, the toothpaste helps to keep your teeth strong and less susceptible to decay. Regular use can contribute significantly to maintaining your dental health.

Dosage and Administration

To keep your teeth healthy, it's important to brush thoroughly, ideally after each meal or at least twice a day. This applies to both adults and children aged 2 years and older. If you're helping a child between 2 and 6 years old, make sure to use only a pea-sized amount of toothpaste and supervise them while they brush and rinse to prevent swallowing any toothpaste.

For children under 2 years old, it's best to consult with a dentist or physician before starting any brushing routine. They can provide guidance tailored to your child's needs. Remember, good dental hygiene is essential for everyone!

What to Avoid

It's important to ensure that you use this product safely. Keep it out of reach of children under 6 years old to prevent any accidental ingestion. If a child accidentally swallows more than what is typically used for brushing, seek medical help immediately or call the Poison Control Center at (412) 390-3381.

There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this product. However, always follow the usage instructions carefully to ensure your safety and well-being.

Side Effects

It's important to keep this product out of reach of children under 6 years old. If a child accidentally swallows more than what is typically used for brushing, seek medical help immediately or call the Poison Control Center at (412) 390-3381.

Always use this product as directed to minimize any risks associated with accidental ingestion. Your safety is a priority, so please be cautious.

Warnings and Precautions

It's important to keep this product out of reach of children under 6 years old to prevent accidental ingestion. If a child accidentally swallows more than what is typically used for brushing, seek medical help immediately or call the Poison Control Center at (412) 390-3381.

Always use this product as directed and be cautious about the amount used. If you have any concerns or experience unusual symptoms, stop using the product and contact your doctor for further advice. Your safety is a priority, so don’t hesitate to reach out for help if needed.

Overdose

If you accidentally swallow more of this product than what is typically used for brushing your teeth, it’s important to seek medical help immediately. You can call the Poison Control Center at (412) 390-3381 for guidance.

Signs of an overdose may not always be obvious, so it's best to err on the side of caution. If you suspect an overdose, don’t hesitate to reach out for help. Your safety is the priority, and prompt action can make a difference.

Pregnancy Use

When considering the use of SIMPLY WHITE CLEAN MINT - sodium fluoride paste, dentifrice during pregnancy, it's important to note that there is no specific information available regarding its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the effects of this product on pregnancy have not been clearly studied or established.

If you are pregnant or planning to become pregnant, it’s always best to consult with your healthcare provider before using any new products, including dental care items. They can provide personalized advice based on your health needs and circumstances.

Lactation Use

When it comes to breastfeeding while using Simply White Clean Mint - sodium fluoride paste, there is no specific information available about its effects on nursing mothers or lactation (the process of producing milk). This means that the safety of this product during breastfeeding hasn't been clearly established.

If you are breastfeeding and have concerns about using this toothpaste, it’s always a good idea to consult with your healthcare provider. They can provide personalized advice based on your situation and help ensure both you and your baby stay healthy.

Pediatric Use

It's important to keep this product out of reach of children under 6 years old. If a child accidentally swallows more than the amount used for brushing, seek medical help immediately or call the Poison Control Center at (412) 390-3381.

For children aged 2 years and older, you should help them brush their teeth thoroughly, ideally after each meal or at least twice a day, using only a pea-sized amount of the product. When brushing for children aged 2 to 6, make sure to supervise them to reduce the risk of swallowing. If your child is under 2 years old, consult with a dentist or physician before use.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach to using this medication safely and effectively, considering any unique health needs or conditions that may be present. Always prioritize open communication with your healthcare team to ensure the best outcomes.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help monitor your liver function and make any necessary adjustments to your care.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any health concerns to receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from freezing conditions. It's important to handle the product carefully and to discard it after opening to maintain safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should use this dental product by brushing your teeth thoroughly after each meal or at least twice a day, unless your dentist or physician gives you different instructions. If you are supervising a child aged 2 to 6, make sure to help them brush and rinse to reduce the risk of swallowing. For children under 2 years old, it's best to consult with a dentist or physician before use.

FAQ

What is Tom's of Maine Simply White Anticavity Toothpaste?

Tom's of Maine Simply White Anticavity Toothpaste is a natural toothpaste with fluoride that comes in a clean mint flavor, designed to remineralize enamel and prevent cavities.

Is this toothpaste safe for children?

Yes, it is safe for children 2 years of age and older. For children 2 to 6 years, use only a pea-sized amount and supervise their brushing.

What should I do if my child accidentally swallows more toothpaste than used for brushing?

If more than the recommended amount is swallowed, get medical help or call the Poison Control Center at (412) 390-3381 immediately.

How should I use this toothpaste?

Brush your teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.

Are there any contraindications for using this toothpaste?

No contraindications are listed for Tom's of Maine Simply White Anticavity Toothpaste.

Is this toothpaste tested on animals?

No, Tom's of Maine Simply White Anticavity Toothpaste is not tested on animals and contains no artificial flavors, sweeteners, or dyes.

What is the storage recommendation for this toothpaste?

Store the toothpaste at room temperature and protect it from freezing. Discard after opening.

Is there any information regarding the use of this toothpaste during pregnancy or lactation?

No specific information regarding the use of this toothpaste during pregnancy or lactation is provided.

Packaging Info

Below are the non-prescription pack sizes of Simply White (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Simply White.
Details

Drug Information (PDF)

This file contains official product information for Simply White, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the prevention of dental caries (cavities) and is classified as an anticavity toothpaste. It aids in the protection against cavities by remineralizing tooth enamel, thereby enhancing the overall health of the teeth.

There are no teratogenic or nonteratogenic effects associated with this product, indicating its safety profile in these contexts.

Dosage and Administration

Adults and children aged 2 years and older are advised to brush their teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or physician.

For children aged 2 to 6 years, it is recommended to use only a pea-sized amount of the product. Caregivers should supervise the child's brushing and rinsing to minimize the risk of swallowing.

For children under 2 years of age, consultation with a dentist or physician is necessary before use.

Contraindications

Use is contraindicated in children under 6 years of age. Accidental ingestion of amounts exceeding those recommended for brushing requires immediate medical attention or contact with the Poison Control Center at (412) 390-3381.

Warnings and Precautions

It is imperative to keep this product out of the reach of children under 6 years of age to prevent accidental ingestion and potential harm.

In the event that more than the recommended amount used for brushing is accidentally swallowed, immediate medical assistance should be sought. Healthcare professionals are advised to contact the Poison Control Center at (412) 390-3381 for guidance and support in managing the situation effectively.

Side Effects

Patients should be aware of the following warnings associated with the use of this product. It is crucial to keep the product out of reach of children under 6 years of age to prevent accidental ingestion. In the event that more than the recommended amount for brushing is accidentally swallowed, it is imperative to seek medical assistance immediately or contact the Poison Control Center at (412) 390-3381.

These precautions are essential to ensure the safety and well-being of patients, particularly young children who may be more susceptible to adverse effects from improper use.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Simply White (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Simply White.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of this product. In the event that more than the recommended amount for brushing is accidentally swallowed, immediate medical assistance should be sought by contacting the Poison Control Center at (412) 390-3381.

For children aged 2 years and older, it is recommended to brush teeth thoroughly, preferably after each meal or at least twice daily, using only a pea-sized amount of the product. Supervision is advised for children aged 2 to 6 years during brushing and rinsing to minimize the risk of swallowing. For infants and children under 2 years of age, consultation with a dentist or physician is recommended prior to use.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information regarding the use of SIMPLY WHITE CLEAN MINT - sodium fluoride paste, dentifrice during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution and consider the lack of data when advising women of childbearing potential regarding the use of this product during pregnancy. It is recommended that the potential benefits be weighed against any unknown risks to fetal outcomes.

Lactation

There is no specific information regarding the use of Simply White Clean Mint - sodium fluoride paste, dentifrice in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider this lack of data when advising lactating mothers on the use of this product.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If an individual accidentally swallows more than the amount typically used for brushing, it is imperative to seek medical help without delay. Healthcare professionals should advise contacting the Poison Control Center at (412) 390-3381 for further guidance.

Prompt intervention is essential to manage potential complications associated with overdosage. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and address any adverse effects that may arise. It is recommended that medical personnel follow established protocols for the management of overdosage, which may include supportive care and symptomatic treatment as necessary.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children under 6 years of age to prevent accidental ingestion.

In the event that more than the recommended amount used for brushing is accidentally swallowed, patients should be instructed to seek medical help immediately or contact the Poison Control Center at (412) 390-3381. It is important for patients to understand the potential risks associated with improper use of the product and to act promptly in case of an emergency.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from freezing conditions. Once opened, the product must be discarded to maintain safety and efficacy.

Additional Clinical Information

The product is administered via the dental route. For adults and children aged 2 years and older, it is recommended to brush teeth thoroughly after each meal or at least twice daily, or as directed by a dentist or physician. For children aged 2 to 6 years, supervision during brushing and rinsing is advised to minimize the risk of swallowing. For children under 2 years, consultation with a dentist or physician is recommended prior to use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Simply White, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Simply White, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.