2025-10253Notice

FDA Requires Single Packs for Kid-Safe Dissolving Meds

Published Date: 6/5/2025

Notice

Summary

The FDA wants to make sure certain over-the-counter medicines that dissolve in your mouth come in single-use packages. This change helps keep doses safe and easy to use, especially for kids and busy folks. If this rule passes, drug makers will need to update their packaging soon, which might cost a bit but will make medicine safer for everyone.

Analyzed Economic Effects

1 provisions identified: 1 benefits, 0 costs, 0 mixed.

Single‑Use Packaging for ODT/Film Drugs

If finalized, the FDA will require over-the-counter drugs that dissolve in your mouth (orally disintegrating tablets and films) to be packaged in single‑unit or unit‑dose containers. You may see drug makers update packaging soon, which the agency says will help keep doses safe and easy to use for consumers, including children and busy people.

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Key Dates

Published Date
6/5/2025

Department and Agencies

Department
Independent Agency
Agency
Health and Human Services Department
Food and Drug Administration
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