FDA Notification Regarding Isometheptene-Containing Drug Products

[June 13, 2018] FDA notified manufacturers and labelers (see list below) on October 12, 2017, to stop distributing their isometheptene mucate-containing drug products (containing either isometheptene mucate, dichloralphenazone, and acetaminophen or isometheptene mucate, caffeine, and acetaminophen). As of January 1, 2018, all of these companies agreed to cease distribution of the unapproved isometheptene-containing drugs.

FDA considers isometheptene-containing drug products unapproved new drugs that cannot be distributed in interstate commerce without a new drug application approved by FDA. The distribution of any unapproved isometheptene-containing drug product, not limited to the drug products listed below, is considered to be marketed unlawfully and subject to enforcement action.

Unapproved Isometheptene Mucate Drug Products and NDCs

PRODUCT NDC	PROPRIETARY NAME
71186-005	Isometheptene Mucate, Dichloralphenazone, and Acetaminophen
35573-310	Isometheptene Mucate, Caffeine, and Acetaminophen
35573-311	Isometheptene Mucate, Dichloralphenazone, and Acetaminophen
44183-440	Isometheptene Mucate, Dichloralphenazone, and Acetaminophen
44183-442	Nodolor
51293-617	Isometheptene Mucate/Dichloralphenazone/Acetaminophen
42195-145	Isometheptene Mucate, Caffeine, and Acetaminophen
15014-145	Prodrin
58657-401	Isometheptene-Dichloral-APAP
42291-344	Isometheptene-Dichloral-APAP
58716-937	Isometheptene Mucate, Caffeine, and Acetaminophen