Dimethicone

Drug Facts label

Every over-the-counter medicine must carry a “Drug Facts” box in the same order, set by FDA rules. Below is the label of one product for each common strength and form, quoted word for word. Your own package can differ (for example, children’s products have other directions): always follow the label on your package.

This page is not medical advice. Read the label on your package, and ask a pharmacist or doctor if you are not sure a medicine is right for you, for your child, or with your other medicines.

Same medicine, other brands

Each group lists the products that have exactly the same active ingredient, in the same amount and form, as registered with the FDA (NDC Directory). A store brand in the same group has the same medicine as the name brand; inactive ingredients, flavors and package sizes can differ. Each product links to its own official label.

62 more strengths and forms are listed in the FDA NDC Directory.

Companies that sell this medicine

The company named on the package (maker or distributor), as listed in the FDA NDC Directory, with its number of over-the-counter products of this medicine.

• Medline Industries, LP12 products
• Kenvue Brands LLC11 products
• The Mentholatum Company8 products
• H E B8 products
• Walgreens8 products
• Strategic Sourcing Services LLC7 products
• Distribuidora Comercial Jafra, S.A. de C.V.6 products
• United Natural Foods, Inc. dba UNFI6 products
• Atlantic Biologicals Corp.6 products
• Pioneer Life Sciences, LLC5 products
• Walgreen Co.5 products
• Rejoice International5 products
• CVS Pharmacy, Inc.5 products
• Amazon.com Services LLC4 products
• Target Corporation4 products
• L. Perrigo Company4 products
• Chain Drug Marketing Association, Inc.4 products
• C.B. Fleet Company, Inc.4 products
• Geri-Care Pharmaceuticals, Corp4 products
• Topco Associates, LLC4 products
• Rejoice International Inc.4 products
• Shield Pharmaceuticals Corp3 products
• Discount Drug Mart, Inc3 products
• Infirst Healthcare3 products
• Central Solutions Inc3 products
• Allegiant Health3 products
• Bionpharma Inc.3 products
• Advance Pharmaceutical Inc.3 products
• Best Choice (Valu Merchandisers Company)3 products
• Harris Teeter, LLC3 products

Showing the 30 companies with the most products, of 158.

Recalls

From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific products or lots: check the name and lot number on your package.

1. June 11, 2026 · Class II · Ongoing · D-0663-2026

   Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.

   Medline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 80090 2 FL OZ (59 mL) NDC 53329-159-13 4 FL OZ (118 mL) NDC 53329-159-04 — BioMed Laboratories, LLC.

2. May 28, 2024 · Class II · Terminated · D-0557-2024

   cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.

   Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dist by Medtech Products Inc., Tarrytown, NY 10591, NDC 63029-103-02 — Denison Pharmaceuticals, LLC

3. July 29, 2016 · Class I · Terminated · D-0229-2017

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

   COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over shipper sold in a) 3- — Sage Products LLC

4. July 29, 2016 · Class II · Terminated · D-0230-2017

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

   COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over shipper sold in a) 3- — Sage Products LLC

5. August 27, 2014 · Class II · Terminated · D-1573-2014

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

   Comfort Shield Barrier Cream Cloths with dimethicone a) 8 count NDC 53462-915-80, b) 24 count NDC 53462-915-60, OTC, SAGE PRODUCTS INC., 3909 Three Oaks Road, Cary, IL 60013 — Sage Products Inc

Sources

1. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
4. FDA rule for the Drug Facts label (21 CFR 201.66)

Only medicines marketed under FDA rules for nonprescription drugs (an FDA monograph or an FDA approval) are listed. Homeopathic products are not listed: the FDA does not evaluate them for safety or effectiveness.

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