Drugplain

Methyl Salicylate 10 g/100g

Methyl Salicylate 10% · PATCH · Florrax Pharmaceutical Corp.

10 Recalls on Record
Plain English

Methyl Salicylate is a patch containing methyl salicylate 10% at 10 g/100g, taken topical. Manufactured by Florrax Pharmaceutical Corp..

Key Facts

Brand Name
Methyl Salicylate
Generic Name
Methyl Salicylate 10%
NDC Code (Product)
84460-103
Manufacturer
Florrax Pharmaceutical Corp.
Strength
10 g/100g
Dosage Form
PATCH
Route
TOPICAL
Marketing Status
Application #
505G(a)(3)
Marketing Start
02/10/2025

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 10%. It is a patch 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 10%. There are 7 other brand versions of Methyl Salicylate 10%.

What is the NDC code for Methyl Salicylate 10 g/100g?

The NDC (National Drug Code) for Methyl Salicylate 10 g/100g is 84460-103, listed by Florrax Pharmaceutical Corp..