FDA Deems Vintage Phenaphen-Codeine Safe for Generic Comeback
Published Date: 9/3/2026
Notice
Summary
The Food and Drug Administration (FDA or Agency) has determined that PHENAPHEN WITH CODEINE NO. 3 (acetaminophen; codeine phosphate) oral capsules, 325 milligrams (mg) and 30 mg, and PHENAPHEN WITH CODEINE NO. 4 (acetaminophen; codeine phosphate) oral capsules, 325 mg and 60 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for PHENAPHEN WITH CODEINE NO. 3 (acetaminophen; codeine phosphate) oral capsules, 325 mg and 30 mg, and PHENAPHEN WITH CODEINE NO. 4 (acetaminophen; codeine phosphate) oral capsules, 325 mg and 60 mg, if all other legal and regulatory requirements are met.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Generics May Be Approved For Two Codeine Capsules
If you make generic drugs, FDA has determined that PHENAPHEN WITH CODEINE NO. 3 (acetaminophen; codeine phosphate) 325 mg / 30 mg and PHENAPHEN WITH CODEINE NO. 4 (acetaminophen; codeine phosphate) 325 mg / 60 mg were not withdrawn for safety or effectiveness. Because of this, FDA can approve abbreviated new drug applications (ANDAs) that refer to these listed drugs (ANDA Nos. 084445 and 084446) if all other legal and regulatory requirements are met.
FDA May Require Updated Labeling For Applicants
If FDA decides that the labeling for these products should be updated to meet current standards, the Agency will advise ANDA applicants to submit revised labeling. This means generic applicants for PHENAPHEN WITH CODEINE NO. 3 (325 mg/30 mg) and NO. 4 (325 mg/60 mg) may need to prepare and submit updated labels as part of the approval process.
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