OTC Medicines

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The CHPA Analysis of Reportability of Changes to New Drug Application (NDA) Over-the-Counter (OTC) Product Labeling Table was developed to assess the reportability of changes to OTC products subject to new drug applications.

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Federal oversight by the FDA ensures that ingredients and chemical additives used in vital healthcare products available to consumers, like nonprescription drugs, dietary supplements, and medical devices, routinely undergo the most rigorous safety evaluations.

Due to the wide variety of changes that may be encountered after an OTC monograph drug is marketed, it is impossible to address stability requirements for all changes in this guideline. However, guidance from the examples provided here can be used in the decision-making process.

Since the Final Rule was published in 1995, FDA has received six Citizen Petitions (CPs) requesting the addition of alternatives to the animal caries test to the Anticaries Monograph.

Dextromethorphan serves as a safe, effective antitussive ingredient in many critical OTC cough and cold formulations. While reasonable age restrictions may curb adolescent misuse without limiting adult access, lawmakers should refrain from unnecessary additional barriers. Targeted age controls strike the right balance between safety and availability.

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The Health in Hand Foundationleads influential, innovative educational initiatives that address specific areas where consumers need guidance and support.

While VOCs can have environmental impacts in aggregate, existing alternatives don’t always provide the consistent therapeutic results needed for OTC products relied upon by millions for. As such, any legislation aimed at further restricting pharmaceutical VOCs must carefully weigh potential unintended consequences on public health.

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