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Orajel

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Active ingredient
Sodium Fluoride 1.5 mg/1 g
Other brand names
Dosage form
Gel, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2026
Label revision date
January 5, 2026
Active ingredient
Sodium Fluoride 1.5 mg/1 g
Other brand names
Dosage form
Gel, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2026
Label revision date
January 5, 2026
Manufacturer
Church & Dwight Co. , Inc.
Registration number
M021
NDC root
10237-734

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If you are a consumer or patient please visit this version.

Drug Overview

Orajel Naturals Anti-Cavity Toothpaste is a specially formulated toothpaste designed for children aged 2 to 10 years. It contains fluoride, which helps in the prevention of dental decay and protects against cavities. This toothpaste also aids in strengthening tooth enamel and keeping gums healthy, all while featuring a natural watermelon flavor that makes brushing more enjoyable for kids.

Uses

Using this product can help you maintain good oral health by preventing dental decay. It works to protect against cavities, which are holes in your teeth caused by decay. Additionally, it helps strengthen your tooth enamel, the hard outer layer that protects your teeth, and keeps your gums healthy. By incorporating this into your dental care routine, you can support your overall oral hygiene effectively.

Dosage and Administration

To keep your teeth healthy, it's important to brush thoroughly after meals or at least twice a day. This applies to both adults and children aged 2 years and older. If you have any specific questions about how to use the product, you can also follow the guidance of your dentist or physician.

For children under 6 years old, it's essential to teach them good brushing and rinsing habits to help prevent swallowing toothpaste. If your child is under 2 years old, it's best to consult with a dentist or physician for advice on how to care for their teeth properly.

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 or contact a Poison Control Center immediately.

While there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this product, always use it as directed 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 or contact a Poison Control Center immediately. This precaution helps ensure their safety and well-being.

Warnings and Precautions

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 their teeth, you should seek medical help or contact a Poison Control Center immediately.

Always use this product as directed and be aware of any unusual reactions. If you experience any concerning symptoms or side effects, stop using the product and call your doctor for 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 or contact a Poison Control Center. This is crucial to ensure your safety and receive the appropriate care.

Signs of an overdose may not be obvious, but if you experience any unusual symptoms after swallowing too much, don’t hesitate to reach out for assistance. Always prioritize your health and well-being by acting quickly in these situations.

Pregnancy Use

There is currently no specific information available about the use of Orajel Toy Story 5 Anticavity Toothpaste during pregnancy. This means that the drug insert does not provide details on safety concerns, dosage adjustments, or any special precautions you should take if you are pregnant or planning to become pregnant.

If you have any questions or concerns about using this product while pregnant, it’s best to consult with your healthcare provider for personalized advice. They can help you make informed decisions based on your individual health needs.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to know that there is no specific information available regarding the use of this medication during nursing. This means that the effects on breast milk and your baby are not clearly defined.

As always, it's best to consult with your healthcare provider about any medications you are considering while breastfeeding. They can help you weigh the benefits and risks to ensure the safety of both you and your baby.

Pediatric Use

It's important to keep this product out of reach of children under 6 years old. If your child accidentally swallows more than the amount used for brushing, seek medical help or contact a Poison Control Center immediately. Always supervise young children while they are using the product until they can do so safely on their own.

For children aged 2 years and older, encourage them to brush their teeth thoroughly after meals or at least twice a day, or follow the guidance of a dentist or physician. For those under 6 years, teach them proper brushing and rinsing techniques to help reduce the chance of swallowing. If your child is under 2 years old, consult with a dentist or physician before use.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about any other medications being taken or health changes that occur.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

It's always best to consult with your healthcare provider about your specific situation, as they can offer personalized advice and ensure that any medications you take are safe and effective for you.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help monitor your liver function and determine the best course of action for your treatment.

Make sure to keep your doctor informed about your liver health, as they may need to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. Currently, there are no specific drug interactions or laboratory test interactions noted for this medication. However, every individual’s health situation is unique, and your provider can help ensure that your treatment plan is safe and effective for you. Always feel free to ask questions and share all the medications and supplements you are using to avoid any potential issues.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from freezing conditions. Once you open the product, remember to discard it after use to maintain safety and effectiveness. Following these simple guidelines will help you handle the product safely and effectively.

Additional Information

This medication is administered through the dental route, meaning it is used in the mouth, typically for oral care. 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 or contact a Poison Control Center immediately.

Make sure to supervise young children while they use this product until they can do so safely on their own. Additionally, teach children under 6 good brushing and rinsing habits to help minimize the risk of swallowing the product.

FAQ

What is Orajel Naturals Anti-Cavity Toothpaste?

Orajel Naturals Anti-Cavity Toothpaste is a fluoride toothpaste designed for children ages 2-10 years, featuring a natural watermelon flavor.

How does Orajel Naturals Anti-Cavity Toothpaste work?

It aids in the prevention of dental decay, protects against cavities, helps strengthen enamel, and keeps gums healthy.

What are the instructions for using this toothpaste?

Children 2 years and older should brush their teeth thoroughly after meals or at least twice a day. Children under 6 years should be instructed in good brushing and rinsing habits to minimize swallowing.

Are there any warnings for using this toothpaste?

Yes, keep out of reach of children under 6 years. If more than used for brushing is accidentally swallowed, seek medical help or contact a Poison Control Center immediately.

Is there any information regarding use during pregnancy or nursing?

No specific information is provided regarding the use of Orajel Naturals Anti-Cavity Toothpaste during pregnancy or nursing.

How should I store this toothpaste?

Store at room temperature, protect from freezing, and discard after opening.

Are there any contraindications or risks associated with this toothpaste?

There are no contraindications, abuse risks, or dependence concerns listed for Orajel Naturals Anti-Cavity Toothpaste.

Packaging Info

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

Packaging configurations for Orajel.
Details

Drug Information (PDF)

This file contains official product information for Orajel, 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 drug.

Uses and Indications

This drug is indicated for the prevention of dental decay. It aids in protecting against cavities, strengthens enamel, and promotes healthy gums.

Dosage and Administration

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

For children under 6 years of age, it is important to instruct them in proper brushing and rinsing techniques to minimize the risk of swallowing the product.

For children under 2 years, consultation with a dentist or physician is recommended prior to use.

Contraindications

Use is contraindicated in children under 6 years of age due to the risk of accidental ingestion. In the event of accidental swallowing of an amount greater than that used for brushing, immediate medical assistance or contact with a Poison Control Center is advised.

Warnings and Precautions

It is imperative to keep this product out of the reach of children under 6 years of age. In the event that more than the recommended amount for brushing is accidentally ingested, immediate medical assistance should be sought, or contact with a Poison Control Center is advised without delay.

Healthcare professionals should ensure that caregivers are aware of these critical safety measures to prevent accidental ingestion and potential harm to young children.

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. In the event that more than the recommended amount used for brushing is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

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 the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Orajel.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the product. In the event that more than the recommended amount for brushing is accidentally swallowed, immediate medical assistance or contact with a Poison Control Center is advised.

Children aged 2 years and older are recommended to brush their teeth thoroughly after meals or at least twice a day, or as directed by a dentist or physician. For children under 6 years, it is important to instruct them in proper brushing and rinsing techniques to minimize swallowing. For infants and children under 2 years, consultation with a dentist or physician is recommended prior to use.

Supervision of children is necessary until they are capable of using the product without assistance.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of Orajel Toy Story 5 Anticavity Toothpaste 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.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. The effects on breastfed infants have not been established, and further research may be necessary to determine safety and efficacy in this population.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with liver problems.

Overdosage

In the event of an overdosage, it is critical to seek immediate medical assistance or contact a Poison Control Center if an amount exceeding that typically used for brushing is accidentally ingested.

Healthcare professionals should be aware that prompt intervention is essential in managing potential overdosage scenarios. Symptoms may vary depending on the specific substance involved, and monitoring for any adverse effects is recommended.

Management procedures should include supportive care and symptomatic treatment as necessary. It is advisable to have the product's labeling and any relevant patient information readily available when contacting medical professionals or poison control for guidance.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children under 6 years of age to prevent accidental ingestion. It is important to emphasize the potential risks associated with misuse. Instruct patients that if more than the recommended amount used for brushing is accidentally swallowed, they should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and preventing adverse effects.

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. Clinicians should advise patients to keep the product out of reach of children under 6 years of age. In the event that more than the recommended amount is accidentally swallowed, immediate medical assistance or contact with a Poison Control Center is necessary. It is important for caregivers to supervise children until they are capable of using the product without supervision and to instruct children under 6 years on proper brushing and rinsing techniques to minimize swallowing.

Drug Information (PDF)

This file contains official product information for Orajel, 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 Orajel, 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.

Learn more in our Editorial Policy

Last AI update:

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.