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Goodsense Oral Pain Relief

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Active ingredient
Benzocaine 20 g/100 g
Other brand names
Drug class
Standardized Chemical Allergen
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2014
Label revision date
January 12, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 20 g/100 g
Other brand names
Drug class
Standardized Chemical Allergen
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2014
Label revision date
January 12, 2026
Manufacturer
Geiss, Destin and Dunn, Inc.
Registration number
M017
NDC root
50804-191
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

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

Drug Overview

This product is designed for use in adults and children aged 2 years and older to help with oral health. It is applied directly to the cavity and the surrounding gums, typically up to four times a day or as directed by a dentist or doctor. For children under 12, supervision is recommended during use, while it should not be used in children under 2 years of age.

While specific details about the drug's mechanism of action or additional context were not provided, it is important to follow the usage instructions carefully to ensure safety and effectiveness.

Uses

You can use this product to help with oral care for both adults and children aged 2 years and older. Simply apply a small amount to the cavity and the gum area around the teeth, up to four times a day, or as your dentist or doctor advises. If you're using it for children under 12, make sure they are supervised during application. However, this product is not recommended for children under 2 years of age.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this product.

Dosage and Administration

It seems that there are no specific dosage or administration details available for this medication. This means that you should consult your healthcare provider for personalized instructions on how to take or apply the medication. They will provide you with the necessary information regarding the correct dosage, how to use it, and how often you should take it to ensure it works effectively for you. Always follow your healthcare provider's guidance to ensure safe and effective use.

What to Avoid

It's important to use this medication safely to ensure your well-being. You should not use it more than directed or for longer than 7 days unless your doctor advises otherwise. Additionally, avoid using this medication for teething, and do not give it to children under 2 years of age. Following these guidelines will help you use the medication effectively and safely.

Side Effects

Using this product may lead to a serious condition called methemoglobinemia, which reduces the amount of oxygen in your blood. This can happen even if you've used the product before. If you or a child experiences symptoms like pale, gray, or blue skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness, or fatigue, stop using the product immediately and seek medical help.

Additionally, if your child has a known allergy to local anesthetics such as procaine, butacaine, or benzocaine, do not use this product. You should also consult a doctor if sore mouth symptoms do not improve within 7 days, or if you notice any irritation, pain, redness, swelling, rash, or fever.

Warnings and Precautions

Using this product may lead to a serious condition called methemoglobinemia, which reduces the amount of oxygen in your blood. This can happen even if you've used it before. If you or a child experiences symptoms like pale, gray, or blue skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness, or fatigue, stop using the product immediately and seek emergency medical help.

If your child has a history of allergies to local anesthetics such as procaine, butacaine, or benzocaine, do not use this product. Additionally, if the symptoms of a sore mouth do not improve within 7 days, or if you notice irritation, pain, redness, swelling, rash, or fever, stop using the product and contact your doctor.

In case of accidental swallowing, get medical help or contact a Poison Control Center at 1-800-222-1222 right away.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical help.

In case of an emergency, call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

It's important to be cautious when using this product for children. You should not use it in children under 2 years of age, including for teething relief. For children aged 2 years and older, you can use the product, but it's essential to supervise them during its use to ensure safety.

If your child shows any signs of methemoglobinemia, which can include pale, gray, or blue skin (known as cyanosis), headache, rapid heart rate, shortness of breath, dizziness, or unusual fatigue, you should stop using the product immediately and seek medical attention. Keeping a close eye on your child while using this product will help ensure their safety.

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 before starting the medication. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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 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 determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want 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. 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 feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance and safety of your product, store it at a temperature between 20-25°C (68°-77°F). This temperature range helps maintain the integrity of the device.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. If you have any specific disposal instructions, please follow them carefully to ensure safe and responsible disposal.

Additional Information

You should apply a small amount of the product to the cavity and the gums surrounding your teeth, up to four times a day or as directed by your dentist or doctor. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this product.

Make sure to keep it out of reach of children. If the product is swallowed, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is the recommended usage for adults and children 2 years of age and older?

You should remove the cap, cut the tip of the tube, and apply a small amount of the product to the cavity and around the gum surrounding the teeth. Use it up to 4 times daily or as directed by a dentist or doctor.

Are there any age restrictions for using this product?

Children under 2 years of age should not use this product. Children under 12 years should be supervised while using it.

What should I do if I notice symptoms of methemoglobinemia?

Stop using the product and seek immediate medical attention if you or a child develops symptoms such as pale, gray, or blue colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness, or fatigue.

Can this product be used for teething in children?

No, do not use this product for teething in children under 2 years of age.

What should I do if sore mouth symptoms do not improve?

If sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists, stop using the product and consult a doctor.

What precautions should I take if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using this product.

What should I do if the product is swallowed?

If swallowed, get medical help or contact a Poison Control Center at 1-800-222-1222 immediately.

How should I store this product?

Store the product at 20-25°C (68°-77°F).

Is there an allergy alert for this product?

Yes, do not use this product if your child has a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other 'caine' anesthetics.

Packaging Info

Below are the non-prescription pack sizes of Goodsense Oral Pain Relief (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Goodsense Oral Pain Relief.
Details

Drug Information (PDF)

This file contains official product information for Goodsense Oral Pain Relief, 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 topical application in adults and children aged 2 years and older for the treatment of oral cavity conditions. It is to be applied in a small amount to the cavity and around the gums surrounding the teeth, with a maximum usage of up to four times daily or as directed by a dentist or doctor.

Children under 12 years of age should be supervised during the use of this product to ensure safe application. The use of this product is contraindicated in children under 2 years of age.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

There is currently no specific dosage or administration information available for this medication. Healthcare professionals are advised to refer to the prescribing information or clinical guidelines for detailed instructions regarding the appropriate dosage, route, method, and frequency of administration. It is essential to consider individual patient factors and clinical judgment when determining the appropriate treatment regimen.

Contraindications

Use is contraindicated in the following situations:

  • Do not exceed the recommended dosage.

  • Do not use for a duration exceeding 7 days unless directed by a healthcare professional.

  • Do not administer for teething relief.

  • Use is contraindicated in children under 2 years of age.

Warnings and Precautions

The use of this product carries significant warnings and precautions that healthcare professionals must communicate to patients and caregivers.

Methemoglobinemia Warning This product may induce methemoglobinemia, a serious condition characterized by reduced oxygen transport in the blood. Symptoms can manifest even in individuals who have previously used the product without issue. Immediate medical attention is required if the patient or a child in their care exhibits any of the following symptoms: cyanosis (pale, gray, or blue-colored skin), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, or fatigue and lack of energy.

Allergy Alert Healthcare professionals should advise against the use of this product in patients with a known allergy to local anesthetics, including but not limited to procaine, butacaine, benzocaine, or other "caine" anesthetics.

Emergency Medical Assistance In the event of accidental ingestion, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Consultation with a Healthcare Provider Patients should be instructed to discontinue use and consult a healthcare provider if any of the following occur: sore mouth symptoms persist beyond 7 days, irritation, pain, or redness does not resolve, or if swelling, rash, or fever develops. These symptoms may indicate a need for further evaluation and management.

Side Effects

The use of this product may lead to serious adverse reactions, including methemoglobinemia, a condition that significantly reduces the oxygen-carrying capacity of the blood. Patients should be aware that methemoglobinemia can occur even after prior use of the product. Immediate medical attention is required if symptoms such as pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, or fatigue or lack of energy develop.

Additionally, an allergy alert is warranted for patients with a known history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics. The use of this product is contraindicated in these individuals.

Patients are advised to discontinue use and consult a healthcare professional if sore mouth symptoms do not improve within 7 days, or if irritation, pain, or redness persists. Furthermore, any development of swelling, rash, or fever should prompt immediate medical consultation.

Drug Interactions

There are currently no documented drug interactions associated with 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 Goodsense Oral Pain Relief (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Goodsense Oral Pain Relief.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this product, including for teething purposes. For children aged 2 years and older, the product may be used, but supervision is recommended during its administration.

Healthcare professionals should be vigilant for symptoms of methemoglobinemia in pediatric patients, which may include pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, and fatigue or lack of energy. If any of these symptoms occur, immediate medical attention should be sought.

Geriatric Use

There is no specific information available 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

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment.

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 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 absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, altered mental status, cardiovascular instability, or gastrointestinal disturbances.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. Healthcare professionals should also consider contacting a poison control center for additional guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, monitor for symptoms, and provide appropriate supportive care in the event of an overdose.

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 understanding of the potential toxicological profile in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified the potential for methemoglobinemia associated with the use of this product. Methemoglobinemia is a serious condition that can reduce the amount of oxygen carried in the blood and requires prompt treatment. Reports indicate that this condition may occur even in individuals who have previously used the product without incident.

Healthcare professionals and patients are advised to discontinue use and seek immediate medical attention if symptoms such as pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, or fatigue or lack of energy develop.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children. Instruct patients that if the medication is swallowed, they should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed not to exceed the recommended dosage and to refrain from using the medication for more than 7 days unless directed by a healthcare professional. It is important to emphasize that this medication should not be used for teething purposes.

Providers should caution patients against using the medication in children under 2 years of age. Additionally, patients should be instructed to stop using the medication and consult a doctor if sore mouth symptoms do not improve within 7 days. They should also be advised to discontinue use and seek medical advice if they experience irritation, pain, or redness that does not resolve, or if any swelling, rash, or fever develops.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25°C (68°-77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent exposure to extreme temperatures, which may compromise the product's quality.

Additional Clinical Information

The product is administered topically, with a recommended application of a small amount to the cavity and the surrounding gum area, up to four times daily or as directed by a dentist or doctor.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before use. Additionally, it is important to keep the product out of reach of children; in the event of ingestion, medical assistance should be sought immediately or contact a Poison Control Center at 1-800-222-1222. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Goodsense Oral Pain Relief, 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 Goodsense Oral Pain Relief, 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

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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.