U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Development & Approval Process (Drugs)
  4. Development Resources
  5. Over-the-Counter (OTC) Drugs
  6. Status of OTC Rulemakings
  7. Rulemaking History for OTC Leg Muscle Cramp Drug Products
  1. Over-the-Counter (OTC) Drugs

Rulemaking History for OTC Leg Muscle Cramp Drug Products

Rulemaking History for OTC Leg Muscle Cramp Drug Products

Monograph (21 CFR 310.546):
Drug products containing active ingredients offered over-the-counter (OTC) for the treatment and/or prevention of nocturnal leg muscle cramps

FDA Archive-It webpage:

Search for Federal Register documents:

Leg Muscle Cramp Drug Products

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking10/1/198247FR43562
Proposed RuleDateFR Citation
Tentative Final Monograph11/8/198550FR46588
    Correction12/2/198550FR49409
Final RuleDateFR Citation
Final Monograph8/22/199459FR43234
    Correction9/28/199459FR49350
    Notice: Enforcement Action12/15/200671FR75557