Itch Relief Spray
NDC Package 81522-751-25
Package Information
Itch Relief (diphenhydramine hcl) sprays is diphenhydramine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. This formulation utilizes a spray delivery system. Marketed by Fsa Store Inc., this product is identified by NDC 81522-751 and is authorized under FDA application M017.
Identification & Billing
- RxCUI: 1050080 - diphenhydrAMINE HCl 2 % Topical Spray
- RxCUI: 1050080 - diphenhydramine hydrochloride 20 MG/ML Topical Spray
- RxCUI: 1050080 - diphenhydramine HCl 2 % Topical Spray
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 81522 - Fsa Store Inc.
- 81522-751 - Itch Relief
- 81522-751-25 - 74 mL in 1 BOTTLE, SPRAY
- 81522-751 - Itch Relief
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 81522-751-25 identifies a specific commercial package of 74 ml in 1 bottle, spray of Itch Relief, a human over the counter drug labeled by Fsa Store Inc.. This spray is formulated for topical use and contains diphenhydramine hydrochloride as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Fsa Store Inc. on August 19, 2025. The current certification is valid through December 31, 2026.
What are the primary indications for this medication?
Diphenhydramine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. These symptoms include rash, itching, watery eyes, itchy eyes/nose/throat, cough, runny nose, and sneezing. It is also used to prevent and treat nausea, vomiting and dizziness caused by motion sickness. Diphenhydramine can also be used to help you relax and fall asleep. This medication works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Its drying effects on such symptoms as watery eyes and runny nose are caused by blocking another natural substance made by your body (acetylcholine). Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).
How is this Fsa Store Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 81522075125. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.