Is codeine a controlled substance? A detailed look at its classification

October 10, 2025 •

2 min read

Worldwide, codeine is one of the most widely used opioid medications, and its classification as a controlled substance in the United States is not as straightforward as it may seem. The answer to "Is codeine a controlled substance?" is yes, but its specific Drug Enforcement Administration (DEA) schedule varies significantly depending on whether it is a pure drug or part of a combination product.

Quick Summary

Codeine is a controlled substance in the United States, but its classification can range from Schedule II to Schedule V depending on its formulation and concentration, reflecting its varying potential for abuse and dependence. This is a crucial distinction for both prescribers and patients to understand, impacting legal access and regulations.

Key Points

Variable Classification: Codeine's DEA schedule depends on its formulation and concentration, ranging from Schedule II to Schedule V.
Pure Codeine is Schedule II: Uncombined codeine is a Schedule II substance due to its high abuse potential and risk of severe dependence.
Combination Products are Schedule III or V: Codeine combined with other medications is typically a Schedule III or V substance, with lower schedules for lower concentrations.
Misuse Risks: Despite being weaker than some other opioids, codeine misuse carries significant risks, including respiratory depression, overdose, and addiction.
Global Changes: International regulations on codeine have become stricter, with many countries moving to a prescription-only model due to misuse concerns.

Understanding the Controlled Substances Act

The Controlled Substances Act (CSA), enacted in 1970, regulates substances with abuse potential in the U.S.. The DEA schedules substances into five categories based on medical use, abuse potential, and dependence risk. These schedules range from Schedule I (high abuse potential, no medical use) to Schedule V (low abuse potential, limited dependence potential). Codeine's classification falls within Schedules II through V, depending on its specific composition.

The Complex Scheduling of Codeine

Codeine's classification varies based on its formulation and concentration.

Schedule II: Pure Codeine

Pure codeine, without other active ingredients, is a Schedule II substance due to its high abuse potential and risk of severe dependence. Pure codeine tablets are rarely prescribed in the U.S..

Schedule III: Combination Products

Codeine combined with other medications, such as acetaminophen, is typically Schedule III if it contains less than 90 milligrams of codeine per dosage unit. These have a moderate-to-low physical dependence potential and high psychological dependence potential.

Schedule V: Low-Dose Preparations

Cough preparations with limited codeine (e.g., less than 200 mg per 100 ml or 100 grams) are classified as Schedule V. Examples include certain Robitussin AC or Phenergan with Codeine formulations. The FDA restricts these prescription opioid cough medicines to adults 18 and older due to risks.

Why the Variable Classification?

This tiered classification system balances codeine's therapeutic benefits against its potential for harm, allowing for its medical use while attempting to mitigate abuse issues.

A Comparison of Codeine with Other Opioids

Codeine is considered a relatively mild opioid compared to others. The table below highlights key differences:


Feature	Codeine (Pure)	Codeine (Combination)	Hydrocodone	Oxycodone
DEA Schedule (U.S.)	Schedule II	Schedule III or V	Schedule II	Schedule II
Abuse Potential	High	Moderate to Low	High	High
Potency	Mild to Moderate	Mild to Moderate	Significantly Stronger	Stronger
Dependence	Severe psychological and physical	Moderate physical or high psychological	Severe psychological and physical	Severe psychological and physical
Common Uses	Pain relief, cough suppression	Mild-to-moderate pain, cough	Moderate-to-severe pain	Moderate-to-severe pain

Abuse Potential and Health Risks

Codeine misuse is a concern, with risks including respiratory depression, overdose, and addiction. Illicit use, such as mixing codeine syrup with soft drinks ('purple drank'), increases overdose risk.

A Global Perspective on Codeine Regulations

Regulations for codeine vary globally. Many countries, including Australia and France, have moved to prescription-only status for codeine products due to misuse concerns, a shift highlighting the global recognition of its abuse potential. The International Narcotics Control Board monitors codeine use.

Conclusion: Navigating Codeine's Status

Is codeine a controlled substance? Yes, but its DEA schedule varies by formulation and concentration. Pure codeine is Schedule II, while combination products are Schedule III or V. This reflects a balance between therapeutic value and abuse potential. Awareness of these distinctions is crucial for safe and legal use, as misuse carries serious health risks, including addiction, overdose, and death. More information on controlled substance classifications can be found on the official DEA website.

Frequently Asked Questions

Codeine's schedule varies based on its formulation. Pure codeine has a higher potential for abuse and is a Schedule II substance. When combined with other medications in specific, limited concentrations, its abuse potential is considered lower, leading to a Schedule III or V classification.

Yes, products like Tylenol with codeine are controlled substances. They are typically classified as Schedule III because they contain less than 90 milligrams of codeine per dosage unit, reflecting a moderate-to-low potential for abuse.

Yes, it is possible to develop a physical and psychological dependence on codeine, even when taking it as prescribed, especially with prolonged use. Dependence can lead to tolerance and withdrawal symptoms if use is stopped abruptly.

While codeine was once available over-the-counter in some countries, regulations have changed dramatically. In the U.S., it requires a prescription. Many other countries, including Australia and France, have also moved to prescription-only status for codeine products.

The most serious risks of codeine misuse are respiratory depression (dangerously slow or shallow breathing), overdose, and addiction. Mixing codeine with other central nervous system depressants, like alcohol, significantly increases these dangers.

The FDA has restricted the use of prescription opioid cough medicines containing codeine to individuals 18 and older, as the risks outweigh the benefits in children. It is also not recommended for breastfeeding women due to the risk of infant sedation and respiratory depression.

'Purple drank,' also known as 'sizzurp' or 'lean,' is a recreational drug concoction made by mixing codeine-containing cough syrup with soft drinks. This illicit misuse is extremely dangerous and can lead to overdose and death.