Medicine
Rhofade 1% cream
Rhofade 1% cream is a prescription medicine containing Oxymetazoline for topical use, marketed by Mayne 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°C-25°C (68°F-77°F), excursions permitted to 15°C-30ºC (59°F- 86ºF).
Key facts
- Active ingredient (INN)
- Oxymetazoline
- Brand
- Rhofade
- Strength
- 1%
- Dosage form
- Cream
- Route
- Topical
- Packs
- 15 tubes, 1 tube and 2 more
- Marketing authorisation holder
- Mayne Pharma
- Manufacturers
- Mayne PharmaEPI Health
- Origin register
- US FDA, United States
- Storage
- Store at 20°C-25°C (68°F-77°F), excursions permitted to 15°C-30ºC (59°F- 86ºF).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- D11AX27 Oxymetazoline
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 18 January 2021
- Identifiers
- RxCUI 1869816, 1869821DailyMed set ID f7dbf12e-a802-4261-bae2-c20977698933, 34298db6-647d-480d-88a8-dc53258a5164, e82b5788-a855-4165-a81f-7f15cb874612NDC 51862-765, 68308-766, 71403-003Application NDA208552
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 |
|---|---|---|---|
| 15 tube in 1 carton / 3 g in 1 tube | 51862-765-00 | Mayne Pharma | 11 July 2025 |
| 1 tube in 1 carton / 30 g in 1 tube | 51862-765-30 | Mayne Pharma | 24 October 2024 |
| 1 tube in 1 carton / 30 g in 1 tube | 68308-766-30 | Mayne Pharma | 15 July 2026 |
| 1 tube in 1 carton / 3 g in 1 tube | 71403-003-15 | EPI Health | 18 January 2021 |
| 1 tube in 1 carton / 30 g in 1 tube | 71403-003-30 | EPI Health | 18 January 2021 |
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 30 May 1986 | 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 Oxymetazoline 1% cream.
Other strengths and forms of Oxymetazoline
Clinical summary
Oxymetazoline is a vasoconstrictor indicated for the topical treatment of persistent facial erythema associated with rosacea in adults. It is available as cream and eye drops for topical and ophthalmic use. MedsAcross supplies Oxymetazoline 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 OxymetazolineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Rhofade prescribing information (Mayne Pharma) · U.S. National Library of Medicine, DailyMed
Need Rhofade 1% cream 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.