What schedule is codeine considered? A Guide to Its Variable DEA Classification

October 8, 2025 •

3 min read

According to the 2023 National Survey on Drug Use and Health, 2 million people misused codeine products, highlighting its significant potential for abuse. To prevent misuse, regulations have been established, and understanding what schedule is codeine considered is crucial for patients, prescribers, and pharmacists. Its classification is not static but varies depending on the product's composition and concentration.

Quick Summary

Codeine's DEA schedule is not uniform, but rather depends on whether it is in its pure form or combined with other active ingredients. Pure codeine is a Schedule II narcotic, while combination products are categorized as Schedule III or V based on the amount of codeine per dosage unit or volume. This variable classification is due to the differing potentials for abuse and dependence.

Key Points

Variable Classification: The DEA schedule for codeine depends on whether it's pure (Schedule II) or in a combination product (Schedule III or V).
Pure Codeine is Schedule II: Pure codeine has a high potential for abuse and dependence, similar to other potent opioids like morphine.
Lower Abuse Potential in Combinations: When combined with other non-narcotic ingredients, codeine's abuse potential is considered lower, leading to Schedule III or V classification.
Schedule III Specifics: Products containing up to 90mg of codeine per dosage unit are classified as Schedule III, exemplified by Tylenol with Codeine.
Schedule V Specifics: Cough preparations with limited quantities of codeine (up to 200mg/100ml) are Schedule V, such as Robitussin AC.
Risk of Dependence: All codeine products carry a risk of physical and psychological dependence, even those in lower schedules, especially with prolonged use.
Federal vs. State Law: Always consider both federal DEA regulations and local state laws, which may have additional restrictions on controlled substances.

Understanding the Controlled Substances Act (CSA)

In the United States, the Drug Enforcement Administration (DEA) regulates certain drugs under the Controlled Substances Act (CSA). This federal law divides controlled substances into five different schedules, based on their potential for abuse, accepted medical use, and safety. The higher the schedule number, the lower the abuse potential. While Schedule I drugs have no accepted medical use and a high potential for abuse, substances in Schedules II through V are legally available for medical use under strict regulations.

The DEA's scheduling system helps to govern prescribing, dispensing, and record-keeping practices to prevent the diversion and misuse of these medications. For a drug like codeine, which has several different pharmaceutical applications, its precise classification can be complex. Its status as a potent opioid means it is always a controlled substance, but its schedule changes dramatically depending on whether it's pure or diluted in a combination product.

The Variable Scheduling of Codeine

The most important factor determining the schedule for a codeine-containing medication is its concentration and whether it is combined with other non-narcotic active medicinal ingredients. This tiered system recognizes that while pure codeine carries a high risk, the abuse potential can be mitigated by combining it with other compounds that limit its psychoactive effects. This is why the same active ingredient, codeine, can be found in products spanning Schedules II, III, and V.

Codeine as a Schedule II Controlled Substance

In its pure, standalone form, codeine is classified as a Schedule II narcotic. This is because Schedule II drugs have a high potential for abuse and severe physical or psychological dependence. While Schedule II substances have a currently accepted medical use, they are subject to strict regulations, such as typically not being refillable.

Codeine in Combination Products

When codeine is compounded with one or more non-narcotic active medicinal ingredients, its abuse potential is considered lower, resulting in a less restrictive schedule. The specific schedule is determined by the maximum concentration or amount of codeine allowed in the product. Preparations containing not more than 90 milligrams of codeine per dosage unit combined with other non-narcotic active ingredients are classified as Schedule III. These products have a potential for abuse less than Schedule I or II and may lead to moderate or low physical dependence or high psychological dependence. Acetaminophen with codeine is an example of a Schedule III product.

Schedule V substances have the lowest potential for abuse among controlled substances. Codeine preparations are classified as Schedule V if they contain not more than 200 milligrams of codeine per 100 milliliters or per 100 grams, along with other active medicinal ingredients. These are often cough or antidiarrheal preparations, like Robitussin AC or Phenergan with Codeine. A full comparison of codeine schedules can be found on the {Link: DEA Diversion Control Division website https://www.deadiversion.usdoj.gov/schedules/schedules.html}.

Potential for Dependence and Misuse

All codeine products, regardless of schedule, carry a risk of dependence and misuse, especially with long-term use. Even Schedule V products can lead to dependence if used inappropriately. Factors like genetics, history of substance use, or co-occurring mental health disorders can increase the risk of addiction. Signs of addiction include using more than prescribed and neglecting responsibilities. Monitoring for these signs and seeking help if a substance use disorder develops is critical. For more detailed information, consult the official DEA Diversion Control Division website.

Conclusion

In conclusion, the schedule for codeine is not fixed; pure codeine is Schedule II due to its high abuse potential, while combination products are categorized as Schedule III or V based on concentration and composition. This variability reflects the differing risks of abuse. Understanding these regulations is vital for safe and appropriate use and to mitigate the risks of dependence and addiction.

Note: State laws regarding controlled substances can differ from federal regulations. Always consult a healthcare provider or pharmacist for guidance on specific medications and their legal status in your area.

Frequently Asked Questions

Codeine can be either a Schedule II or Schedule III drug, depending on its formulation. In its pure form, it is Schedule II. When compounded with other ingredients, like in Tylenol with Codeine, it is a Schedule III controlled substance.

Tylenol with codeine (products containing not more than 90 milligrams of codeine per dosage unit) is considered a Schedule III controlled substance under federal law.

Codeine has multiple schedules because the DEA classifies controlled substances based on their potential for abuse and dependence, which is affected by concentration and combination with other ingredients. Combining codeine with other non-narcotic ingredients effectively reduces its overall abuse potential, leading to a less restrictive schedule.

Yes, some formulations of promethazine with codeine, such as cough syrup containing not more than 200 milligrams of codeine per 100 milliliters, are classified as Schedule V controlled substances.

Yes, it is possible to develop a physical or psychological dependence on any codeine product, including Schedule V cough syrup. While the abuse potential is lower than in Schedule II and III, misuse or prolonged use can lead to addiction.

Schedule II pure codeine has the highest potential for abuse and dependence, leading to severe physical or psychological dependency. Schedule III combinations have a moderate to low potential for physical dependence but high psychological dependence. Schedule V preparations have the lowest abuse potential and a limited risk of physical or psychological dependence.

You can determine the schedule by checking the medication's label or asking your doctor or pharmacist. The key factors are the product's concentration and whether it's a combination with other active ingredients.