Drugplain

Menthol 105 mg/1

MENTHOL, UNSPECIFIED FORM · PATCH · Unexo Life Sciences Private Limited

10 Recalls on Record
Plain English

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

10 Recalls on Record
Class II10/26/2021

Perrigo Company PLC

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

TerminatedVoluntary: Firm initiated
Class II04/17/2024

ARG Laboratories, Inc.

Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.

OngoingVoluntary: Firm initiated
Class III03/07/2013

Novartis Consumer Health

Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.

TerminatedVoluntary: Firm initiated
Class II03/20/2026

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.

OngoingVoluntary: Firm initiated
Class III04/27/2022

Bestco LLC

Subpotent drug: Low OOS for menthol content at the three month room temperature.

TerminatedVoluntary: Firm initiated
Class II05/19/2020

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.

OngoingVoluntary: Firm initiated
Class II10/24/2024

Unexo Life Sciences Private Limited

cGMP Deviations

TerminatedVoluntary: Firm initiated
Class II07/01/2020

Preferred Pharmaceuticals, Inc.

CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test results for the recalled batch.

TerminatedVoluntary: Firm initiated
Class II10/24/2024

Unexo Life Sciences Private Limited

cGMP Deviations

TerminatedVoluntary: Firm initiated
Class II08/02/2023

Parker Laboratories, Inc.

CGMP Deviations

TerminatedVoluntary: Firm initiated

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.