Prescription medicine
Codeine and promethazine
Codeine and promethazine is a prescription medicine with an FDA approval on record since 1952. FDA's NDC Directory lists it from 5 generic labelers, and pharmacies paid $0.0697 per mL (Promethazine-codeine solution) in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
- DEA Schedule V
Check it at the source: the codeine and promethazine FDA label on DailyMed (effective December 18, 2025, Cosette Pharmaceuticals, Inc.); the NDA 8306 record on Drugs@FDA; every codeine and promethazine label on DailyMed.
Highlights of the record
FDA label of December 18, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; PROMETHAZINE AND RESPIRATORY DEPRESSION IN CHILDREN; MEDICATION ERRORS; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; NEONATAL OPIOID WITHDRAWAL SYNDROME.
Addiction, Abuse, and Misuse Promethazine HCl and Codeine Phosphate Oral Solution exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Reserve Promethazine HCl and Codeine Phosphate Oral Solution for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made. Assess each patient’s risk prior to prescribing Promethazine HCl and Codeine Phosphate Oral Solution, prescribe Promethazine HCl and Codeine Phosphate Oral Solution for the shortest duration that is consistent with individual patient treatment goals, monitor all patients regularly for the development of addiction or abuse, and refill only after reevaluation of the need for continued treatment. [ see Warnings and Precautions (5.1) ]. […]
Used for
From the label: indications and usagePromethazine HCl and Codeine Phosphate Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older.
Forms and strengths
- 6.25 mg/5ml / 10 mg/5ml
Solution.
On the market
- Earliest approval on file
- January 21, 1952 Phenergan W/ Codeine, Ani Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 11 first October 31, 1984; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 5 of which 5 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0697 per mL Promethazine-codeine solution
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 3,559 through July 30, 2026
What is codeine and promethazine used for?
From the label: indications and usagePromethazine HCl and Codeine Phosphate Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older. Important Limitations of Use Not indicated for pediatric patients under 18 years of age [ see Use in Specific Populations (8.4) ]. Contraindicated in pediatric patients under 12 years of age [ see Contraindications (4), Use in Specific Populations (8.4) ]. Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [ see Contraindications (4), Use in Specific Populations (8.4) ]. […]
Conditions named in the indications of codeine and promethazine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Opioid Agonist and Phenothiazine.
Source: FDA drug label (Promethazine Hydrochloride and Codeine Phosphate), Cosette Pharmaceuticals, Inc., effective December 18, 2025 (SPL set 3b02cda4-9b24-79c9-e063-6294a90af5b9), via openFDA; the full label on DailyMed
What does the patient leaflet for codeine and promethazine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about Promethazine Hydrochloride and Codeine Phosphate Oral Solution?Promethazine Hydrochloride and Codeine Phosphate Oral Solution is not for children under 18 years of age. Promethazine Hydrochloride and Codeine Phosphate Oral Solution can cause serious side effects, including: Addiction, abuse and misuse. Taking Promethazine Hydrochloride and Codeine Phosphate Oral Solution or other medicines that contain an opioid can cause addiction, abuse, and misuse, which can lead to overdose and death. This can happen even if you take Promethazine Hydrochloride and Codeine Phosphate Oral Solution exactly as prescribed by your healthcare provider. Your risk of addiction, abuse, and misuse is increased if you or a family member has a history of drug or alcohol abuse or addiction, or mental health problems. Do not share your Promethazine Hydrochloride and Codeine Phosphate Oral Solution with other people. Keep Promethazine Hydrochloride and Codeine Phosphate Oral Solution in a safe place away from children. Life-threatening breathing problems (respiratory depression). Promethazine Hydrochloride and Codeine Phosphate Oral Solution can cause breathing problems (respiratory depression) that can happen at any time during treatment and can lead to death. Your risk of breathing problems is greatest when you first start taking Promethazine Hydrochloride and Codeine Phosphate Oral Solution, are taking other medicines that can cause breathing problems, have certain lung problems, are elderly or have certain other health problems. Children are at higher risk for respiratory depression. Breathing problems can happen even if you take Promethazine Hydrochloride and Codeine Phosphate Oral Solution exactly as prescribed by your healthcare provider. […]
From the patient leaflet: What should I avoid while taking Promethazine Hydrochloride and Codeine Phosphate Oral Solution?Avoid driving a car or operating machinery during treatment with Promethazine Hydrochloride and Codeine Phosphate Oral Solution. Promethazine Hydrochloride and Codeine Phosphate Oral Solution can cause you to be drowsy, slow your thinking and motor skills, and affect your vision. Do not drink alcohol during treatment with Promethazine Hydrochloride and Codeine Phosphate Oral Solution. Drinking alcohol with Promethazine Hydrochloride and Codeine Phosphate Oral Solution can increase your chances of having serious side effects, accidental overdose, and cause death. Avoid the use of Promethazine Hydrochloride and Codeine Phosphate Oral Solution if you: are pregnant. Use of Promethazine Hydrochloride and Codeine Phosphate Oral Solution during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. […]
From the patient leaflet: How should I store Promethazine Hydrochloride and Codeine Phosphate Oral Solution?Store Promethazine Hydrochloride and Codeine Phosphate Oral Solution at room temperature between 68°F to 77°F (20°C to 25°C). Store Promethazine Hydrochloride and Codeine Phosphate Oral Solution in a tightly closed container, in a dry, cool place away from heat or direct sunlight. Keep Promethazine Hydrochloride and Codeine Phosphate Oral Solution and all medicines out of the reach of children.
Source: FDA drug label (Promethazine Hydrochloride and Codeine Phosphate), Cosette Pharmaceuticals, Inc., effective December 18, 2025 (SPL set 3b02cda4-9b24-79c9-e063-6294a90af5b9), via openFDA; the full label on DailyMed
Is there a generic for codeine and promethazine?
The FDA approved the first generic codeine and promethazine on October 31, 1984. 11 generic applications are approved; 5 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists codeine and promethazine from 5 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1952 earliest approval on file
- 1984 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for codeine and promethazine?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0697 per mL (Promethazine-codeine solution), up 72% from $0.0406 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Promethazine-codeine solution (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Promethazine-codeine solution | Generic | $0.0697 per mL | n/a | +72% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the codeine and promethazine label say about other medicines?
The codeine and promethazine label names 13 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amiodarone | warnings and precautions | Risks of Concomitant Use or Discontinuation of Cytochrome P450 2D6 Inhibitors The concomitant use of Promethazine HCl and Codeine Phosphate Oral Solution with all cytochrome P450 2D6 inhibitors (e.g., amiodarone, quinidine) may result in an increase in codeine plasma concentrations and a decrease in active metabolite … |
| Bupropion | drug interactions | The concomitant use of Promethazine HCl and Codeine Phosphate Oral Solution and CYP2D6 inhibitors, such as paroxetine, fluoxetine, bupropion, or quinidine, can increase the plasma concentration of codeine, but can decrease the plasma concentration of active metabolite morphine, which could result in reduced efficacy [ … |
| Carbamazepine | drug interactions | The concomitant use of Promethazine HCl and Codeine Phosphate Oral Solution and CYP3A4 inducers, such as rifampin, carbamazepine, or phenytoin, can result in lower codeine levels, greater norcodeine levels, and less metabolism via 2D6 with resultant lower morphine levels [ see Clinical Pharmacology (12.3) ], resulting … |
| Erythromycin | drug interactions | The concomitant use of Promethazine HCl and Codeine Phosphate Oral Solution with CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), or protease inhibitors (e.g., ritonavir), may result in an increase in codeine plasma concentrations with subsequently … |
| Fluoxetine | drug interactions | The concomitant use of Promethazine HCl and Codeine Phosphate Oral Solution and CYP2D6 inhibitors, such as paroxetine, fluoxetine, bupropion, or quinidine, can increase the plasma concentration of codeine, but can decrease the plasma concentration of active metabolite morphine, which could result in reduced efficacy [ … |
| Ketoconazole | drug interactions | The concomitant use of Promethazine HCl and Codeine Phosphate Oral Solution with CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), or protease inhibitors (e.g., ritonavir), may result in an increase in codeine plasma concentrations with subsequently … |
| Morphine | boxed warning | Interactions with Drugs Affecting Cytochrome P450 Isoenzymes The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine are complex, requiring careful consideration of the effects on the parent drug, codeine, and the active metabolite, morphine. |
| Naloxone | warnings and precautions | Management of respiratory depression includes discontinuation of Promethazine HCl and Codeine Phosphate Oral Solution, close observation, supportive measures, and use of opioid antagonists (e.g. naloxone), depending on the patient’s clinical status [ see Overdosage (10) ]. |
| Paroxetine | drug interactions | The concomitant use of Promethazine HCl and Codeine Phosphate Oral Solution and CYP2D6 inhibitors, such as paroxetine, fluoxetine, bupropion, or quinidine, can increase the plasma concentration of codeine, but can decrease the plasma concentration of active metabolite morphine, which could result in reduced efficacy [ … |
| Phenytoin | drug interactions | The concomitant use of Promethazine HCl and Codeine Phosphate Oral Solution and CYP3A4 inducers, such as rifampin, carbamazepine, or phenytoin, can result in lower codeine levels, greater norcodeine levels, and less metabolism via 2D6 with resultant lower morphine levels [ see Clinical Pharmacology (12.3) ], resulting … |
| Quinidine | drug interactions | The concomitant use of Promethazine HCl and Codeine Phosphate Oral Solution and CYP2D6 inhibitors, such as paroxetine, fluoxetine, bupropion, or quinidine, can increase the plasma concentration of codeine, but can decrease the plasma concentration of active metabolite morphine, which could result in reduced efficacy [ … |
| Rifampin | drug interactions | The concomitant use of Promethazine HCl and Codeine Phosphate Oral Solution and CYP3A4 inducers, such as rifampin, carbamazepine, or phenytoin, can result in lower codeine levels, greater norcodeine levels, and less metabolism via 2D6 with resultant lower morphine levels [ see Clinical Pharmacology (12.3) ], resulting … |
| Ritonavir | drug interactions | The concomitant use of Promethazine HCl and Codeine Phosphate Oral Solution with CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), or protease inhibitors (e.g., ritonavir), may result in an increase in codeine plasma concentrations with subsequently … |
Source: FDA drug label (Promethazine Hydrochloride and Codeine Phosphate), Cosette Pharmaceuticals, Inc., effective December 18, 2025 (SPL set 3b02cda4-9b24-79c9-e063-6294a90af5b9), via openFDA; the full label on DailyMed
What do FAERS reports show for codeine and promethazine?
The FDA Adverse Event Reporting System holds 3,559 reports that list codeine and promethazine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 165 are coded as a death and 8 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2023 (3,437, against a median of 1 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as codeine and promethazine?
15 other medicines are given the same way (oral) and in the same FDA class as codeine and promethazine or labeled mainly for the same use (cough and cold), the same class first. Cough and cold lists all 31 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Homatropine methylbromide and hydrocodone | Cough and cold | 3 labelers | $0.922 per tablet 5-1.5 mg tablet | No current entry |
| Chlorpheniramine and hydrocodone | Cough and cold | 2 labelers | $0.556 per mL Hydrocodone-chlorphen ER suspension | No current entry |
| Diphenhydramine | Cough and cold | 4 labelers | $0.0185 per mL 12.5 mg/5 mL | No current entry |
| Dextromethorphan and guaifenesin | Cough and cold | 61 labelers | $0.0207 per mL 200-20 mg/20 mL | No current entry |
| Guaifenesin | Cough and cold | 102 labelers | $0.284 per tablet 600 mg tablet | No current entry |
| Benzonatate | Cough and cold | 45 labelers | $0.0656 per capsule 100 mg capsule | No current entry |
| Dextromethorphan | Cough and cold | 28 labelers | $0.122 per unit 15 mg softgel | No current entry |
| Pseudoephedrine | Cough and cold | 34 labelers | $0.281 per tablet 120 mg tablet | No current entry |
Every medicine labeled for the same conditions as codeine and promethazine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to codeine and promethazine
- 15 medicines for the same use
- Other opioids
- the pharmacologic class, with prices and generics
- Codeine and promethazine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other