Rhofade
- Product NDC
- 51862-765
- 11-digit product format
- 518620765
- Labeler code
- 51862
- Product ID
- 51862-765_1314d411-e0a5-402b-89ff-49847937838d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- oxymetazoline hydrochloride
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Mayne Pharma
- Application
- NDA208552
- Marketing category
- NDA
- Marketing start
- 2024-10-24
- Substance
- OXYMETAZOLINE HYDROCHLORIDE
- Active strength
- 10 mg/g
- Pharmacologic classes
- Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Rhofade
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OXYMETAZOLINE HYDROCHLORIDE | 10 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | K89MJ0S5VY |
| Rxcui | 1869816, 1869821 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51862-765 | RHOFADE (OXYMETAZOLINE HYDROCHLORIDE) CREAM [MAYNE PHARMA] | 1 | Current NDC, 4 package rows | 20241025_f7dbf12e-a802-4261-bae2-c20977698933.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 51862-765-00 | 51862076500 | 15 TUBE in 1 CARTON (51862-765-00) / 3 g in 1 TUBE | 15 tube | 2025-07-11 | No | No | Historical |
| 51862-765-30 | 51862076530 | 1 TUBE in 1 CARTON (51862-765-30) / 30 g in 1 TUBE | 1 tube | 2024-10-24 | No | No | Historical |