MENTHOL 5% 500 mg/10g
menthol 5% · PATCH · Advanced Rx of Tennessee, LLC
MENTHOL 5% is a patch containing menthol 5% at 500 mg/10g, taken transdermal. Manufactured by Advanced Rx of Tennessee, LLC.
Key Facts
- Brand Name
- MENTHOL 5%
- Generic Name
- menthol 5%
- NDC Code (Product)
80425-0543- Manufacturer
- Advanced Rx of Tennessee, LLC
- Strength
- 500 mg/10g
- Dosage Form
- PATCH
- Route
- TRANSDERMAL
- Marketing Status
- Application #
- M017
- Marketing Start
- 08/08/2025
Recall History
Wuhan Bingbing Pharmaceutical Co., Ltd.
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Unexo Life Sciences Private Limited
cGMP Deviations
Preferred Pharmaceuticals, Inc.
CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test results for the recalled batch.
Unexo Life Sciences Private Limited
cGMP Deviations
Wuhan Bingbing Pharmaceutical Co., Ltd.
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Bonita Pharmaceuticals, LLC
Marketed without an approved NDA/ANDA
US Pharmaceuticals Inc.
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Little Moon Essentials LLC
CGMP deviations
CA BOTANA International, Inc.
CGMP Deviations
CA BOTANA International, Inc.
CGMP Deviations
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
USES Temporary relief from minor aches and pains of sore muscles and joints associated with: arthrits backache strains sprains
Dosage & Administration
DIRECTIONS: Adults and Children 12 Years of Age or Over: Clean and dry the affected area, partially peel back the protective film and apply the exposed patch to the site of pain. Carefully remove the remaining film while pressing patch to skin and leave in place for up to 8 hours. Use on affected areas not more than 4 times daily. Wash hands with cool water after use. Children Under 12 Years of Age: Consult physician.
Warnings
WARNINGS For external use only.
Frequently Asked Questions
What is MENTHOL 5% used for?
MENTHOL 5% contains menthol 5%. It is a patch taken transdermal. Consult your doctor for specific uses.
Is MENTHOL 5% a controlled substance?
MENTHOL 5% is not classified as a controlled substance by the DEA.
What is the generic name for MENTHOL 5%?
The generic name for MENTHOL 5% is menthol 5%. There are 10 other brand versions of menthol 5%.
What is the NDC code for MENTHOL 5% 500 mg/10g?
The NDC (National Drug Code) for MENTHOL 5% 500 mg/10g is 80425-0543, listed by Advanced Rx of Tennessee, LLC.
Other MENTHOL 5% Dosages
Other Menthol Brands
See all →- HEALMUSZ NUMBING5 g/100g85248-160
- ANIXIKE Numbing5 g/100g85248-167
- ANIXIKE Cream5 g/100g85248-180
- Walgreens Cold Therapy Pain Relief Patch5 g/100g0363-9950
- DERMFREE NUMBING5 g/100g85248-158
- Dr Sabharwals240 mg/171318-116
- Lidothol ES.056 g/g80425-0561
- Lidothol ES.04 g/g83881-445
- Aemerry Numbing Cream2.5 g/50g87615-002
- SYLVIRENE NUMBING5 g/100g85248-163
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)