Medicine
Promethazine DM 15 mg/6.25 mg per 5 mL oral solution
Promethazine DM 15 mg/6.25 mg per 5 mL oral solution is a prescription medicine containing Dextromethorphan and Promethazine for oral use, marketed by PAI Pharma, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Dextromethorphan and Promethazine
- Brand
- Promethazine DM
- Strength
- 15 mg/6.25 mg per 5 mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 118 mL, 473 mL
- Marketing authorisation holder
- PAI Pharma
- Manufacturer
- PAI Pharma
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 4 June 2025
- Identifiers
- RxCUI 991528DailyMed set ID 1d47280d-28c9-4701-8c5f-a6e6b524083bNDC 0121-1070Application ANDA040649
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 118 mL in 1 bottle | 0121-1070-04 | PAI Pharma | 4 June 2025 |
| 473 mL in 1 bottle | 0121-1070-16 | PAI Pharma | 4 June 2025 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 3 December 1957 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Dextromethorphan and Promethazine 15 mg/6.25 mg per 5 mL oral solution.
Other strengths and forms of Dextromethorphan and Promethazine
Clinical summary
Dextromethorphan and Promethazine is a fixed-dose combination of a phenothiazine, a sigma-1 agonist and an uncompetitive N-methyl-D-aspartate receptor antagonist. It is available as oral solution and syrup. MedsAcross supplies Dextromethorphan and Promethazine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Dextromethorphan and PromethazineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Promethazine Hydrochloride and Dextromethorphan Hydrobromide prescribing information (ANI Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Promethazine DM 15 mg/6.25 mg per 5 mL oral solution for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.