rhofade

Generic: oxymetazoline hydrochloride

Labeler: epi health, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name rhofade
Generic Name oxymetazoline hydrochloride
Labeler epi health, llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

oxymetazoline hydrochloride 1 g/100g

Manufacturer
EPI Health, LLC

Identifiers & Regulatory

Product NDC 71403-003
Product ID 71403-003_d743c06d-1277-4504-803b-5752af09ba03
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208552
Listing Expiration 2026-12-31
Marketing Start 2021-01-18

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 71403003
Hyphenated Format 71403-003

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
  • 1 g/100g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (71403-003-15) / 3 g in 1 TUBE
  • 1 TUBE in 1 CARTON (71403-003-30) / 30 g in 1 TUBE
source: ndc

Packages (2)

71403-003-15 1 TUBE in 1 CARTON (71403-003-15) / 3 g in 1 TUBE 71403-003-30 1 TUBE in 1 CARTON (71403-003-30) / 30 g in 1 TUBE

Ingredients (1)

oxymetazoline hydrochloride (1 g/100g)

Linked Drug Pages (1)

Rhofade ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "d743c06d-1277-4504-803b-5752af09ba03", "openfda": {"unii": ["K89MJ0S5VY"], "rxcui": ["1869816", "1869821"], "spl_set_id": ["e82b5788-a855-4165-a81f-7f15cb874612"], "manufacturer_name": ["EPI Health, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (71403-003-15)  / 3 g in 1 TUBE", "package_ndc": "71403-003-15", "marketing_start_date": "20210118"}, {"sample": false, "description": "1 TUBE in 1 CARTON (71403-003-30)  / 30 g in 1 TUBE", "package_ndc": "71403-003-30", "marketing_start_date": "20210118"}], "brand_name": "Rhofade", "product_id": "71403-003_d743c06d-1277-4504-803b-5752af09ba03", "dosage_form": "CREAM", "pharm_class": ["Imidazolines [CS]", "Increased Sympathetic Activity [PE]", "Vasoconstriction [PE]", "Vasoconstrictor [EPC]"], "product_ndc": "71403-003", "generic_name": "OXYMETAZOLINE HYDROCHLORIDE", "labeler_name": "EPI Health, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rhofade", "active_ingredients": [{"name": "OXYMETAZOLINE HYDROCHLORIDE", "strength": "1 g/100g"}], "application_number": "NDA208552", "marketing_category": "NDA", "marketing_start_date": "20210118", "listing_expiration_date": "20261231"}