Determination That PHENAPHEN WITH CODEINE NO. 3 (Acetaminophen; Codeine Phosphate) Oral Capsules, 325 Milligrams and 30 Milligrams, and PHENAPHEN WITH CODEINE NO. 4 (Acetaminophen; Codeine Phosphate) Oral Capsules, 325 Milligrams and 60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
PHENAPHEN WITH CODEINE NO. 3 and NO. 4 remain available for sale as they were not withdrawn for safety or effectiveness reasons.
Aforeworn detected this change in the Pharmacy & Controlled Substances space on September 3, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated Low urgency. Independent pharmacies, retail chains, compounding pharmacies, and long-term-care pharmacies. should confirm how it applies to their specific situation before acting. There is a time constraint attached: as soon as possible. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Pharmacy & Controlled Substances continuously and turns every detected change into a plain-English briefing like this one, so you always know first. Forewarned is forearmed.
What changed
The determination confirms that these specific codeine-containing products are still approved for sale.
Who it affects
Independent pharmacies, retail chains, compounding pharmacies, and long-term-care pharmacies.
What you must do
Continue to stock and dispense PHENAPHEN WITH CODEINE NO. 3 and NO. 4 as they are not withdrawn.
Deadline
as soon as possible
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