Menthol 105 mg/1
MENTHOL, UNSPECIFIED FORM · PATCH · Unexo Life Sciences Private Limited
Menthol patches are a topical over-the-counter product applied directly to the skin to provide a cooling sensation and help relieve minor aches and pains. The menthol works by creating a numbing effect on the skin surface where the patch is placed.
Key Facts
- Brand Name
- Menthol
- Generic Name
- MENTHOL, UNSPECIFIED FORM
- NDC Code (Product)
71391-128- Manufacturer
- Unexo Life Sciences Private Limited
- Strength
- 105 mg/1
- Dosage Form
- PATCH
- Route
- TOPICAL
- Marketing Status
- Application #
- M017
- Marketing Start
- 11/15/2022
Recall History
Perrigo Company PLC
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
ARG Laboratories, Inc.
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Novartis Consumer Health
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Bestco LLC
Subpotent drug: Low OOS for menthol content at the three month room temperature.
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
Parker Laboratories, Inc.
CGMP Deviations
Frequently Asked Questions
What is Menthol used for?
Menthol patches are a topical over-the-counter product applied directly to the skin to provide a cooling sensation and help relieve minor aches and pains. The menthol works by creating a numbing effect on the skin surface where the patch is placed.
Is Menthol a controlled substance?
Menthol is not classified as a controlled substance by the DEA.
What is the generic name for Menthol?
The generic name for Menthol is MENTHOL, UNSPECIFIED FORM. There are 12 other brand versions of MENTHOL, UNSPECIFIED FORM.
What is the NDC code for Menthol 105 mg/1?
The NDC (National Drug Code) for Menthol 105 mg/1 is 71391-128, listed by Unexo Life Sciences Private Limited.
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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)