Is Promethazine DM (with codeine) a controlled substance?
Yes. Promethazine DM products that contain codeine are generally regulated as controlled substances in the United States. The reason is that codeine is a Schedule II opioid in most formulations, and drug products containing it are treated as controlled under federal law.
If your bottle says “Promethazine DM” and the strength includes codeine (often written as something like 6.25 mg / 5 mL promethazine and 10 mg / 5 mL or 15 mg / 5 mL codeine), it is very likely a controlled substance.
What does the “6.25/15 mg per 5 mL” strength usually mean?
A label like 6.25 mg/5 mL promethazine + 15 mg/5 mL codeine is a common way codeine-containing cough syrups are listed. When codeine is present in that way, the medication is typically covered by controlled-substance rules.
When could it be NOT a controlled substance?
It would usually be not a controlled substance only if the product contains promethazine with dextromethorphan (DM) and does not contain codeine. In that case, it may not fall under opioid controlled-substance scheduling.
How to confirm for your specific prescription
Check the exact active ingredients on the label:
- If you see codeine → it is controlled.
- If you only see dextromethorphan (DM) with promethazine → it typically is not treated as an opioid controlled substance.
If you share the full “Active Ingredients” line from your bottle (including whether it lists codeine or dextromethorphan), I can tell you which situation it matches.
Why this matters for refills and pharmacies
Controlled cough syrups with codeine typically have tighter rules for:
- prescriptions (no refills without a new order depending on the schedule)
- pharmacy handling and documentation
- state-specific restrictions
Sources
No drug-specific source was provided for this question.