Quick Answer (for busy buyers)
Here’s the buyer-first summary. If your brand name is on the label, you usually act as the responsible person and must ensure the listing is submitted and kept current.
- Anti-dandruff shampoo is classified as an OTC drug in the US, which means it requires FDA registration and must use specific active ingredients at approved concentrations.
- This changes the project by adding regulatory documentation requirements and testing protocols.
- MOQ increases to 5,000 units minimum due to additional documentation and testing.
- Sampling timeline extends to 8-12 weeks to accommodate stability and efficacy testing.
- Packaging must include proper drug facts panels and warning statements.
- Lead time increases by 4-6 weeks for regulatory review and documentation preparation.
- We can support with FDA registration assistance and required testing documentation.
Buyer outcome
A launch-ready compliance plan: inputs collected, roles assigned, and update cadence defined.
Most common blocker
Missing facility information + inconsistent ingredient/label snapshots across SKUs.
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This page is a practical buyer guide. For definitive requirements and updates, use FDA resources and qualified regulatory counsel.