DEA schedule

Is Botox a controlled substance?

Botox contains botulinum toxin type a. Federal schedule from the FDA NDC directory, checked against the DEA controlled substances list.

Source: FDA NDC Directory file dated 2026-10-22. Publisher page

No. Botox (botulinum toxin type a) is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and botulinum toxin type a is not on the DEA controlled substances list.

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Schedule check

Schedule sources for Botox
SourceWhat it lists
FDA NDC directory3 prescription listings from 2 labelers, none with a DEA schedule
DEA controlled substances listbotulinum toxin type a is not on the list

Botox NDC listings

NDC listings for Botox
NDCProductFormStrengthLabelerDEA schedule
0023-1145BOTOXinjection, powder, lyophilized, for solution100 [USP'U]/1Allergan, Inc.None
85766-155BOTOXinjection, powder, lyophilized, for solution100 [USP'U]/1Sportpharm LLCNone
0023-3921BOTOXinjection, powder, lyophilized, for solution200 [USP'U]/1Allergan, Inc.None

Questions

Is Botox a controlled substance?

No. Botox (botulinum toxin type a) is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and botulinum toxin type a is not on the DEA controlled substances list.

Is Botox a narcotic?

No. Botox (botulinum toxin type a) is not on the DEA controlled substances list, so the DEA does not classify it as a narcotic. Its FDA established pharmacologic class is Acetylcholine Release Inhibitor and Neuromuscular Blocker.

Does this page cover state schedules?

No. This page reports the federal schedule only. Some states schedule drugs on their own; check your state board of pharmacy.

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