Drug
Who makes oxymetazoline hydrochloride?
3 companies list oxymetazoline hydrochloride as a human prescription drug, including under the names Rhofade. Forms: cream. Routes: topical.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing oxymetazoline hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Mayne Pharma International Pty Ltd.Australia | cream | NDANDA208552 | 2 | 1 |
| Sun Pharmaceutical Industries LimitedIndia | cream | ANDAANDA213584 | 1 | 13 |
| EPI Health, LLC | cream | NDANDA208552 | 1 | 0 |
Bulk ingredient listings
- CTX Lifesciences Pvt. Ltd.India · 1 NDC
- LETCO MEDICAL, LLCUnited States · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- SHODHANA LABORATORIES PRIVATE LIMITEDIndia · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
- Suresource Pharma LLCUnited States · 1 NDC
Orange Book patents
21 unexpired patents list oxymetazoline hydrochloride as the active ingredient, expiring between May 2028 and Dec 2039. Application holders: MAYNE PHARMA LLC, RVL PHARMACEUTICALS INC.
Enquiry
Common questions
- Who makes oxymetazoline hydrochloride?
- 3 companies list oxymetazoline hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Mayne Pharma International Pty Ltd., Sun Pharmaceutical Industries Limited, EPI Health, LLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Rhofade?
- 1 company lists oxymetazoline hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies oxymetazoline hydrochloride active ingredient?
- 6 companies list oxymetazoline hydrochloride as a bulk ingredient, including CTX Lifesciences Pvt. Ltd., LETCO MEDICAL, LLC, Professional Compounding Centers of America dba PCCA, SHODHANA LABORATORIES PRIVATE LIMITED.