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  6. FDA Notification Regarding Isometheptene-Containing Drug Products
  1. Enforcement Activities by FDA

FDA Notification Regarding Isometheptene-Containing Drug Products

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