Itch Relief 20 mg/mL
Diphenhydramine HCl · SPRAY · FSA Store Inc.
Itch Relief is a spray containing diphenhydramine hcl at 20 mg/mL, taken topical. Manufactured by FSA Store Inc..
Key Facts
- Brand Name
- Itch Relief
- Generic Name
- Diphenhydramine HCl
- NDC Code (Product)
81522-751- Manufacturer
- FSA Store Inc.
- Strength
- 20 mg/mL
- Dosage Form
- SPRAY
- Route
- TOPICAL
- Marketing Status
- Application #
- M017
- Marketing Start
- 08/19/2025
Recall History
Mckesson Medical-Surgical Inc. Corporate Office
CGMP Deviations: products were stored outside the drug label specifications.
The Mentholatum Co.
Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.
Mckesson Medical-Surgical Inc. Corporate Office
CGMP Deviations: products were stored outside the drug label specifications.
Ridge Properties, LLC
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
King Bio Inc.
Microbial contamination
King Bio Inc.
Microbial contamination
Akorn, Inc.
CGMP Deviations
Teva Pharmaceuticals USA Inc
Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.
Ridge Properties, LLC
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses ■ for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: ■ eczema ■ psoriasis ■ poison ivy, oak, sumac ■ insect bites ■ detergents ■ jewelry ■ cosmetics ■ soaps ■ seborrheic dermatitis ■ other uses of this product should be only under the advice and supervision of a doctor
Dosage & Administration
D irections ■ adults and children 2 years of age and older : apply to affected area. Do not use more than 3 to 4 times daily. ■ children under 2 years of age: do not use, ask a doctor.
Warnings
Warnings For external use only . Flam mable. Keep away from fire or flame. Do not us e ■ for the treatment of diaper rash. Consult a doctor. ■ if you are allergic to any ingredient in this product. When using this product ■ avoid contact with the eyes ■ contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120° F. ■ use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal. ■ do not use more than directed unless told to do so by a doctor Stop use and ask a doctor if ■ condition worsens ■ symptoms persist for more than 7 days or clear up and occur again within a few days, do not use this or any other hydrocortisone product unless you have asked a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Frequently Asked Questions
What is Itch Relief used for?
Itch Relief contains Diphenhydramine HCl. It is a spray taken topical. Consult your doctor for specific uses.
Is Itch Relief a controlled substance?
Itch Relief is not classified as a controlled substance by the DEA.
What is the generic name for Itch Relief?
The generic name for Itch Relief is Diphenhydramine HCl. There are 11 other brand versions of Diphenhydramine HCl.
What is the NDC code for Itch Relief 20 mg/mL?
The NDC (National Drug Code) for Itch Relief 20 mg/mL is 81522-751, listed by FSA Store Inc..
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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)