Prescription medicine
Dextromethorphan and promethazine
Dextromethorphan and promethazine is a prescription medicine with an FDA approval on record since 1957. FDA's NDC Directory lists it from 12 generic labelers, and pharmacies paid $0.039 per mL (Promethazine-dm 6.25-15 mg/5 mL solution) in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the dextromethorphan and promethazine FDA label on DailyMed (effective August 8, 2025, ANI Pharmaceuticals, Inc.); the NDA 11265 record on Drugs@FDA; every dextromethorphan and promethazine label on DailyMed.
Highlights of the record
FDA label of August 8, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression. Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine in pediatric patients less than 2 years of age. A wide range of weight-based doses of promethazine have resulted in respiratory depression in these patients. Caution should be exercised when administering promethazine to pediatric patients 2 years of age and older. It is recommended that the lowest effective dose of promethazine be used in pediatric patients 2 years of age and older and concomitant administration of other drugs with respiratory depressant effects be avoided.
Used for
From the label: indications and usagePromethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.
Forms and strengths
- 6.25 mg/5ml / 15 mg/5ml
- 15 mg/5ml / 6.25 mg/5ml
Solution; syrup.
On the market
- Earliest approval on file
- December 3, 1957 Promethazine Hydrochloride And Dextromethorphan Hydrobromide, Ani Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 9 first October 31, 1984; 6 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 14 of which 12 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.039 per mL Promethazine-dm 6.25-15 mg/5 mL solution
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 598 through July 30, 2026
What is dextromethorphan and promethazine used for?
From the label: indications and usagePromethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.
Conditions named in the indications of dextromethorphan and promethazine's FDA labels, with every medicine labeled for each:
From other dextromethorphan and promethazine labelsCough and cold: INDICATIONS AND USAGE Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.
FDA pharmacologic class: Phenothiazine, Sigma-1 Agonist and Uncompetitive N-methyl-D-aspartate Receptor Antagonist.
Source: FDA drug label (Promethazine Hydrochloride and Dextromethorphan Hydrobromide), NDA011265 (Ani Pharms), as published by ANI Pharmaceuticals, Inc., effective August 8, 2025 (SPL set a52e210f-b99d-493e-b679-ec565c6ff72d), via openFDA; the full label on DailyMed
Is there a generic for dextromethorphan and promethazine?
The FDA approved the first generic dextromethorphan and promethazine on October 31, 1984. 9 generic applications are approved; 6 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 dextromethorphan and promethazine from 12 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.
- 1957 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 dextromethorphan and promethazine?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.039 per mL (Promethazine-dm 6.25-15 mg/5 mL solution), down 10% from $0.0433 on November 5, 2025. 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-dm 6.25-15 mg/5 mL solution (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Promethazine-dm 6.25-15 mg/5 mL solution | Generic | $0.039 per mL | n/a | -10% |
| Promethazine-dm 6.25-15 mg/5 mL syrup | Generic | $0.039 per mL | n/a | -10% |
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 dextromethorphan and promethazine label say about other medicines?
The dextromethorphan and promethazine label names 1 other medicine 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 |
|---|---|---|
| Epinephrine | drug interactions | Epinephrine – Because of the potential for promethazine to reverse epinephrine’s vasopressor effect, epinephrine should NOT be used to treat hypotension associated with Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution overdose. |
Check dextromethorphan and promethazine against other medicines
Source: FDA drug label (Promethazine Hydrochloride and Dextromethorphan Hydrobromide), NDA011265 (Ani Pharms), as published by ANI Pharmaceuticals, Inc., effective August 8, 2025 (SPL set a52e210f-b99d-493e-b679-ec565c6ff72d), via openFDA; the full label on DailyMed
What do FAERS reports show for dextromethorphan and promethazine?
The FDA Adverse Event Reporting System holds 598 reports that list dextromethorphan and promethazine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 30 are coded as a death and 142 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 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 dextromethorphan and promethazine?
14 other medicines are given the same way (oral) and in the same FDA class as dextromethorphan 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 |
|---|---|---|---|---|
| Diphenhydramine | Cough and cold | 4 labelers | $0.0185 per mL 12.5 mg/5 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 |
| Pseudoephedrine | Cough and cold | 34 labelers | $0.281 per tablet 120 mg tablet | No current entry |
| Guaifenesin and pseudoephedrine | Cough and cold | 30 labelers | $0.384 per unit 600-60 mg | No current entry |
| Phenylephrine | Cough and cold | none listed | $0.0496 per tablet 10 mg tablet | No current entry |
| Loratadine and pseudoephedrine | Cough and cold | 31 labelers | $0.553 per tablet Allergy relief-nasal decong tablet | No current entry |
| Fexofenadine and pseudoephedrine | Cough and cold | 27 labelers | $0.483 per tablet 60-120 tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Other phenothiazines
- the pharmacologic class, with prices and generics
- Dextromethorphan and promethazine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other