Drugplain

Dimethicone 12 mg/mL

Dimethicone · LOTION · Meijer, Inc.

10 Recalls on Record
Plain English

Dimethicone is a lotion containing dimethicone at 12 mg/mL, taken topical. Manufactured by Meijer, Inc..

Key Facts

Brand Name
Dimethicone
Generic Name
Dimethicone
NDC Code (Product)
79481-0496
Manufacturer
Meijer, Inc.
Strength
12 mg/mL
Dosage Form
LOTION
Route
TOPICAL
Marketing Status
Application #
M016
Marketing Start
06/05/2023

Recall History

10 Recalls on Record
Class II07/15/2019

La Fresh Group, Inc.

Marketed without an Approved NDA/ANDA: The product may be construed a sunscreen due to labeling of the product and comments about the product found on e-commerce websites.

TerminatedVoluntary: Firm initiated
Class II08/27/2025

DermaRite Industries, LLC

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

OngoingVoluntary: Firm initiated
Class I07/29/2016

Sage Products LLC

Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.

TerminatedVoluntary: Firm initiated
Class II08/03/2018

Product Quest Manufacturing LLC

Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Staphalococcus aureus.

TerminatedVoluntary: Firm initiated
Class II05/22/2018

Medline Industries Inc (Northpoint Services)

Microbial Contamination of a Non-Sterile Product.

TerminatedVoluntary: Firm initiated
Class II06/10/2024

Brands International Corporation

Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination

OngoingVoluntary: Firm initiated
Class III02/21/2017

Bayer HealthCare Pharmaceuticals, Inc.

Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a labeling claim issue.

TerminatedVoluntary: Firm initiated
Class II08/27/2014

Sage Products Inc

Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive for bacterial contamination.

TerminatedVoluntary: Firm initiated
Class II08/27/2025

DermaRite Industries, LLC

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

OngoingVoluntary: Firm initiated
Class II07/29/2016

Sage Products LLC

CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.

TerminatedVoluntary: Firm initiated

Frequently Asked Questions

What is Dimethicone used for?

Dimethicone contains Dimethicone. It is a lotion taken topical. Consult your doctor for specific uses.

Is Dimethicone a controlled substance?

Dimethicone is not classified as a controlled substance by the DEA.

What is the generic name for Dimethicone?

The generic name for Dimethicone is Dimethicone. There are 11 other brand versions of Dimethicone.

What is the NDC code for Dimethicone 12 mg/mL?

The NDC (National Drug Code) for Dimethicone 12 mg/mL is 79481-0496, listed by Meijer, Inc..