Drugplain

Methyl Salicylate 250 mg/g

Methyl Salicylate · CREAM · Alexso, Inc

10 Recalls on Record
Plain English

Methyl Salicylate is a cream containing methyl salicylate at 250 mg/g, taken topical. Manufactured by Alexso, Inc.

Key Facts

Brand Name
Methyl Salicylate
Generic Name
Methyl Salicylate
NDC Code (Product)
50488-1015
Manufacturer
Alexso, Inc
Strength
250 mg/g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
M017
Marketing Start
04/01/2019

Recall History

10 Recalls on Record
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 II06/21/2019

Pharma-Natural Inc.

CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.

TerminatedVoluntary: Firm initiated
Class II04/24/2025

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class II08/03/2018

Product Quest Manufacturing LLC

Superpotent Drug: high out of specification assay results for the menthol ingredient.

TerminatedVoluntary: Firm initiated
Class II01/27/2016

Bonita Pharmaceuticals, LLC

Marketed without an approved NDA/ANDA

TerminatedVoluntary: Firm initiated
Class II08/02/2023

Parker Laboratories, Inc.

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class III09/05/2023

Vi-Jon, LLC

Incorrect/Undeclared Excipients.

TerminatedVoluntary: Firm initiated
Class II04/24/2025

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class II04/24/2025

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class II05/05/2022

Vi-Jon, LLC

Superpotent Drug: product complaint for milky blue appearance and consistency, further investigation by the firm found the recalled lots out of specification for the four active ingredients.

TerminatedVoluntary: Firm initiated

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use helps control plaque that leads to gingivitis

Dosage & Administration

Directions adults and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth twice a day for 30 seconds then spit out children under 12 years of age - consult a dentist or doctor this rinse is not intended to replace brushing or flossing

Warnings

Warnings for this product

Adverse Reactions

Adverse Reaction SATISFACTION GUARANTEED Distributed By AmerisourceBergen 1 West First Avenue, Conshohocken, PA 19428 Questions or Concerns? 1-888-593-0593 www.mygnp.com DSP-TN-21091 DSP-MO-20087

Frequently Asked Questions

What is Methyl Salicylate used for?

Methyl Salicylate contains Methyl Salicylate. It is a cream taken topical. Consult your doctor for specific uses.

Is Methyl Salicylate a controlled substance?

Methyl Salicylate is not classified as a controlled substance by the DEA.

What is the generic name for Methyl Salicylate?

The generic name for Methyl Salicylate is Methyl Salicylate. There are 12 other brand versions of Methyl Salicylate.

What is the NDC code for Methyl Salicylate 250 mg/g?

The NDC (National Drug Code) for Methyl Salicylate 250 mg/g is 50488-1015, listed by Alexso, Inc.