Are over-the-counter labels required to include a lot number and expiration date?

In Nebraska, the regulation concerning over-the-counter (OTC) drug labeling aligns with federal guidelines, which state that while manufacturers are encouraged to include lot numbers and expiration dates on packaging, it is not mandatory for OTC labels. The primary requirement for OTC products is that they must include specific labeling information for safety, usage instructions, warnings, and active ingredients.

The lack of a mandatory requirement for lot numbers and expiration dates means that products may be sellable without this information, provided they meet the essential labeling specifications. This leads to clarity regarding manufacturing and quality control processes but does not necessitate these details on the product label itself.

In practical terms, while including a lot number and expiration date can be considered best practice for ensuring product traceability and consumer safety, it is not a legal requirement for OTC preparations in Nebraska or under federal regulations.