Drugplain

Menthol .01 g/100mL

Menthol · PASTE · FlexiGo Inc

10 Recalls on Record
Plain English

Menthol is a paste containing menthol at .01 g/100mL, taken topical. Manufactured by FlexiGo Inc.

Key Facts

Brand Name
Menthol
Generic Name
Menthol
NDC Code (Product)
85524-2510
Manufacturer
FlexiGo Inc
Strength
.01 g/100mL
Dosage Form
PASTE
Route
TOPICAL
Marketing Status
Application #
M017
Marketing Start
09/20/2025

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 contains Menthol. It is a paste taken topical. Consult your doctor for specific uses.

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. There are 12 other brand versions of Menthol.

What is the NDC code for Menthol .01 g/100mL?

The NDC (National Drug Code) for Menthol .01 g/100mL is 85524-2510, listed by FlexiGo Inc.