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Nasalcrom
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- Active ingredient
- Cromolyn Sodium 5.2 mg
- Other brand names
- Drug class
- Mast Cell Stabilizer
- Dosage form
- Spray, Metered
- Route
- Nasal
- Prescription status
- OTC (over the counter)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2009
- Label revision date
- October 30, 2025
- Drug Information (PDF)
- Prescribing information, PDF file
- Active ingredient
- Cromolyn Sodium 5.2 mg
- Other brand names
- Drug class
- Mast Cell Stabilizer
- Dosage form
- Spray, Metered
- Route
- Nasal
- 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 2009
- Label revision date
- October 30, 2025
- Manufacturer
- Prestige Brands Holdings, Inc.
- Registration number
- ANDA075702
- NDC root
- 52183-199
- Drug Information (PDF)
- Prescribing information, PDF file
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
NasalCrom is a nasal solution that contains cromolyn sodium, which is used to help prevent and relieve symptoms associated with hay fever and other nasal allergies. If you experience a runny or itchy nose, sneezing, or an allergic stuffy nose, NasalCrom can provide relief from these discomforts.
This medication is safe for individuals aged 2 and older and is available in two sizes, delivering 5.2 mg of cromolyn sodium per spray. It was originally available by prescription, highlighting its effectiveness in managing allergy symptoms.
Uses
If you suffer from hay fever or other nasal allergies, this medication can help you find relief. It is designed to prevent and alleviate common nasal symptoms such as a runny or itchy nose, sneezing, and a stuffy nose caused by allergies.
You can use this medication to manage your symptoms effectively, allowing you to enjoy your daily activities without the discomfort of nasal allergies. Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication.
Dosage and Administration
If you or your child is 2 years old or older and dealing with allergies, you can use a nasal spray to help relieve symptoms. Simply spray once into each nostril, and you can repeat this 3 to 4 times a day, allowing 4 to 6 hours between doses. If necessary, you can use the spray up to 6 times a day. It's best to use the spray every day while you're exposed to allergens like pollen, molds, pets, and dust. For optimal results, start using it up to a week before you expect to come into contact with these allergens to help prevent symptoms.
If your child is under 2 years old, it's important to consult a doctor before using this nasal spray.
What to Avoid
It's important to be cautious when using this product. First, do not use it if you are allergic to any of its ingredients, as this could lead to serious reactions. Additionally, while using this product, avoid using it to treat sinus infections, asthma, or cold symptoms, as it is not intended for these conditions.
You should also refrain from sharing this bottle with anyone else, as doing so can spread germs and increase the risk of infection. Always prioritize your health and safety by following these guidelines.
Side Effects
This product is intended for external use only. You should not use it if you are allergic to any of its ingredients. Before using, consult a doctor if you have a fever, discolored nasal discharge, sinus pain, or wheezing.
While using this product, you may experience brief stinging or sneezing. It’s important not to use it for treating sinus infections, asthma, or cold symptoms, and avoid sharing the bottle to prevent spreading germs. Stop using the product and contact a doctor if you experience shortness of breath, wheezing, chest tightness, hives, or swelling of the mouth or throat. Additionally, seek medical advice if your symptoms worsen, if you develop new symptoms, if you do not see improvement within two weeks, or if you need to use it for more than 12 weeks. If you are pregnant or breastfeeding, consult a health professional before use. Keep this product out of reach of children, and if swallowed, seek medical help immediately.
Warnings and Precautions
This product is for external use only, so please do not apply it to your mouth or swallow it. If you are allergic to any of the ingredients, you should not use this product. Before using it, consult your doctor if you have a fever, discolored nasal discharge, sinus pain, or wheezing.
You should stop using the product and contact your doctor if you experience shortness of breath, wheezing, or chest tightness, or if you develop hives or swelling in your mouth or throat. Additionally, if your symptoms worsen, you notice new symptoms, or if you do not see improvement within two weeks, it's important to reach out to your healthcare provider. If you find that you need to use this product for more than 12 weeks, please consult your doctor as well.
In case of accidental swallowing, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222.
Overdose
If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance.
Signs of an overdose may include unusual symptoms, but specific details on these symptoms are not provided here. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.
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
If your child is 2 years old or older, you can use this nasal spray by administering one spray into each nostril. You can repeat this every 4 to 6 hours, up to 6 times a day if necessary. However, for children under 2 years old, you should only use this product if a doctor specifically advises it.
It's important to supervise young children while using this spray to ensure their safety. Always follow the recommended guidelines to help your child use the product effectively and safely.
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 considering this medication, it’s important to consult with a healthcare provider. 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 drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have renal impairment (kidney issues).
Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help determine the best course of action based on your kidney function and overall health.
Hepatic Impairment
If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (issues with liver function).
Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help you understand how to manage your treatment effectively.
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 of your product, store it in a cool, dry place at a temperature between 20°-25°C (68°-77°F). It's important to keep the product protected from light to maintain its effectiveness. Always retain the carton and package insert, as they contain essential instructions for use and safety. Additionally, check the bottom panel for the lot number and expiration date to ensure you are using a valid product.
By following these simple storage and handling guidelines, you can help ensure the product remains safe and effective for your needs.
Additional Information
No further information is available.
FAQ
What is NasalCrom?
NasalCrom is a cromolyn sodium nasal solution used to prevent and relieve nasal symptoms of hay fever and other nasal allergies.
What symptoms does NasalCrom treat?
It treats symptoms such as a runny or itchy nose, sneezing, and an allergic stuffy nose.
Who can use NasalCrom?
NasalCrom is safe for adults and children aged 2 years and older. Children under 2 should not use it unless directed by a doctor.
How should I use NasalCrom?
For adults and children 2 years and older, spray once into each nostril 3-4 times a day, and it may be used up to 6 times a day if needed.
Are there any side effects of using NasalCrom?
You may experience brief stinging or sneezing right after use. If you have shortness of breath or swelling, stop use and consult a doctor.
Can I use NasalCrom if I am pregnant or breastfeeding?
If you are pregnant or breastfeeding, ask a health professional before using NasalCrom.
What should I do if I accidentally swallow NasalCrom?
If swallowed, get medical help or contact a Poison Control Center immediately.
What should I avoid while using NasalCrom?
Do not use NasalCrom to treat sinus infections, asthma, or cold symptoms, and do not share the bottle with others.
How should I store NasalCrom?
Store NasalCrom between 20°-25°C (68°-77°F) and protect it from light.
Packaging Info
Below are the non-prescription pack sizes of Nasalcrom (cromolyn sodium). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Spray, Metered | 5.2 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Spray, Metered | 5.2 mg | ||
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Drug Information (PDF)
This file contains official product information for Nasalcrom, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.
Description
Cromolyn sodium nasal solution, USP, is formulated to deliver 5.2 mg of cromolyn sodium per spray. It is available in two packaging options: 100 metered sprays in a 0.44 FL OZ (13 mL) bottle and 200 metered sprays in a 0.88 FL OZ (26 mL) bottle.
Uses and Indications
This drug is indicated for the prevention and relief of nasal symptoms associated with hay fever and other nasal allergies. Specifically, it addresses symptoms such as runny nose, itchy nose, sneezing, and allergic nasal congestion.
There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.
Dosage and Administration
Adults and children aged 2 years and older are instructed to administer one spray into each nostril. This may be repeated 3 to 4 times daily, with doses spaced every 4 to 6 hours. If necessary, the spray may be used up to 6 times a day. It is recommended to use the spray daily while in contact with allergens such as pollen, molds, pets, and dust. For optimal prevention of nasal allergy symptoms, it is advised to initiate use up to one week prior to anticipated exposure to allergens.
For children under 2 years of age, the use of this product is not recommended unless directed by a physician.
Contraindications
Use of this product is contraindicated in individuals with a known allergy to any of its ingredients.
Additionally, the product should not be utilized for the treatment of sinus infections, asthma, or cold symptoms due to its specific formulation and intended use.
To prevent the spread of germs, sharing this product with others is also contraindicated.
Warnings and Precautions
For external use only. This product should not be used by individuals who are allergic to any of its ingredients.
Healthcare professionals are advised to recommend that patients consult a doctor prior to use if they present with any of the following conditions: fever, discolored nasal discharge, sinus pain, or wheezing.
Patients should be instructed to discontinue use and seek medical advice if they experience shortness of breath, wheezing, or chest tightness. Additionally, if hives or swelling of the mouth or throat occurs, or if symptoms worsen, new symptoms arise, or if there is no improvement within two weeks, medical consultation is necessary. Prolonged use beyond 12 weeks should also prompt a discussion with a healthcare provider.
In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.
Side Effects
Patients using this product should be aware that it is for external use only. It is contraindicated in individuals with known allergies to any of the ingredients. Prior to use, patients should consult a healthcare professional if they experience fever, discolored nasal discharge, sinus pain, or wheezing.
During the use of this product, patients may experience brief stinging or sneezing immediately after application. It is important to note that this product is not intended for the treatment of sinus infections, asthma, or cold symptoms. Additionally, sharing the bottle with others is discouraged to prevent the spread of germs.
Patients are advised to discontinue use and seek medical attention if they experience shortness of breath, wheezing, or chest tightness, as well as hives or swelling of the mouth or throat. They should also consult a doctor if their symptoms worsen, if new symptoms arise, if symptoms do not improve within two weeks, or if they find it necessary to use the product for more than 12 weeks.
For pregnant or breastfeeding individuals, it is recommended to consult a healthcare professional before use. This product should be kept out of reach of children, and in the event of accidental ingestion, medical help should be sought immediately or contact with a Poison Control Center (1-800-222-1222) should be made.
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 Nasalcrom (cromolyn sodium). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Spray, Metered | 5.2 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Spray, Metered | 5.2 mg | ||
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Pediatric Use
Pediatric patients aged 2 years and older may use the product by administering one spray into each nostril, with the option to repeat this 3-4 times a day (every 4-6 hours). If necessary, the product may be used up to 6 times a day.
For children under 2 years of age, the product should not be used unless directed by a healthcare professional. It is essential that a parent or care provider supervises the use of this product in young children to ensure safety and proper administration. The product is considered safe for pediatric patients aged 2 years and older.
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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.
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 no specific data available regarding the excretion of this medication in 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 have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.
Hepatic Impairment
Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 prescribing information.
Overdosage
In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help without delay. It is recommended to contact a Poison Control Center at 1-800-222-1222 for expert guidance on managing the situation.
Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and implement appropriate management strategies based on the severity of symptoms and the specific substance involved.
Nonclinical Toxicology
If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.
Postmarketing Experience
No postmarketing experience details are available in the provided text.
Patient Counseling
Healthcare providers should advise patients to keep the product out of reach of children. Instruct patients that if the product 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 use the product if they are allergic to any of its ingredients. They should be instructed to stop use and consult a doctor if they experience shortness of breath, wheezing, or chest tightness; hives or swelling of the mouth or throat; worsening symptoms; new symptoms; lack of improvement within two weeks; or if they need to use the product for more than 12 weeks.
When using the product, patients should be made aware that it may take several days to notice an effect, with optimal results potentially not seen for 1 to 2 weeks. They may experience brief stinging or sneezing immediately after use. It is important to inform patients that the product should not be used to treat sinus infections, asthma, or cold symptoms, and they should not share the bottle with others to prevent the spread of germs.
Additionally, healthcare providers should encourage patients to consult a doctor before use if they have a fever, discolored nasal discharge, sinus pain, or wheezing.
Storage and Handling
The product is supplied in a carton that contains important instructions, which should be retained for reference. It is essential to store the product at a temperature range of 20°-25°C (68°-77°F) and to protect it from light exposure. Additionally, users should check the bottom panel of the carton for the lot number and expiration date to ensure proper tracking and usage.
Additional Clinical Information
No further data are available.
Drug Information (PDF)
This file contains official product information for Nasalcrom, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.