rhofade

Generic: oxymetazoline hydrochloride

Labeler: mayne pharma
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name rhofade
Generic Name oxymetazoline hydrochloride
Labeler mayne pharma
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

oxymetazoline hydrochloride 10 mg/g

Manufacturer
Mayne Pharma

Identifiers & Regulatory

Product NDC 51862-765
Product ID 51862-765_1314d411-e0a5-402b-89ff-49847937838d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208552
Listing Expiration 2026-12-31
Marketing Start 2024-10-24

Pharmacologic Class

Classes
imidazolines [cs] increased sympathetic activity [pe] vasoconstriction [pe] vasoconstrictor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51862765
Hyphenated Format 51862-765

Supplemental Identifiers

RxCUI
1869816 1869821
UNII
K89MJ0S5VY

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name rhofade (source: ndc)
Generic Name oxymetazoline hydrochloride (source: ndc)
Application Number NDA208552 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 15 TUBE in 1 CARTON (51862-765-00) / 3 g in 1 TUBE
  • 1 TUBE in 1 CARTON (51862-765-30) / 30 g in 1 TUBE
source: ndc

Packages (2)

51862-765-00 15 TUBE in 1 CARTON (51862-765-00) / 3 g in 1 TUBE 51862-765-30 1 TUBE in 1 CARTON (51862-765-30) / 30 g in 1 TUBE

Ingredients (1)

oxymetazoline hydrochloride (10 mg/g)

Linked Drug Pages (1)

Rhofade ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "1314d411-e0a5-402b-89ff-49847937838d", "openfda": {"unii": ["K89MJ0S5VY"], "rxcui": ["1869816", "1869821"], "spl_set_id": ["f7dbf12e-a802-4261-bae2-c20977698933"], "manufacturer_name": ["Mayne Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 TUBE in 1 CARTON (51862-765-00)  / 3 g in 1 TUBE", "package_ndc": "51862-765-00", "marketing_start_date": "20250711"}, {"sample": false, "description": "1 TUBE in 1 CARTON (51862-765-30)  / 30 g in 1 TUBE", "package_ndc": "51862-765-30", "marketing_start_date": "20241024"}], "brand_name": "Rhofade", "product_id": "51862-765_1314d411-e0a5-402b-89ff-49847937838d", "dosage_form": "CREAM", "pharm_class": ["Imidazolines [CS]", "Increased Sympathetic Activity [PE]", "Vasoconstriction [PE]", "Vasoconstrictor [EPC]"], "product_ndc": "51862-765", "generic_name": "oxymetazoline hydrochloride", "labeler_name": "Mayne Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rhofade", "active_ingredients": [{"name": "OXYMETAZOLINE HYDROCHLORIDE", "strength": "10 mg/g"}], "application_number": "NDA208552", "marketing_category": "NDA", "marketing_start_date": "20241024", "listing_expiration_date": "20261231"}