Medicine
Phenylephrine and Promethazine 5 mg/6.25 mg per 5 mL oral solution
Phenylephrine and Promethazine 5 mg/6.25 mg per 5 mL oral solution is a generic prescription medicine for oral use, made by 2 labelers, 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), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Phenylephrine and Promethazine
- Brand
- Sold under the generic name
- Strength
- 5 mg/6.25 mg per 5 mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 118 mL, 473 mL
- Manufacturers
- Amneal PharmaceuticalsGenus Lifesciences
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°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
- 25 August 2009
- Identifiers
- RxCUI 1248057DailyMed set ID cf4ef7c0-2f4a-4b0f-9060-ad0b909d1ed4, 7f8ebc9c-c4e6-4344-95a5-ec25b8c99bc1NDC 65162-679, 64950-345Application ANDA040902, ANDA040654
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 118 mL in 1 bottle | 65162-679-86 | Amneal Pharmaceuticals | 25 August 2009 |
| 473 mL in 1 bottle | 65162-679-90 | Amneal Pharmaceuticals | 25 August 2009 |
| 473 mL in 1 bottle, plastic | 64950-345-16 | Genus Lifesciences | 15 July 2024 |
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 14 September 1954 | 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
Clinical summary
Phenylephrine and Promethazine is a fixed-dose combination of a phenothiazine and an alpha-1 adrenergic agonist indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold. MedsAcross supplies Phenylephrine 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 Phenylephrine 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 Phenylephrine Hydrochloride prescribing information (Genus Lifesciences) · U.S. National Library of Medicine, DailyMed
Need Phenylephrine and Promethazine 5 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.