NDC 71180-003

Rhofade

Oxymetazoline Hydrochloride

Rhofade is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Aclaris Therapeutics, Inc.. The primary component is Oxymetazoline Hydrochloride.

Product ID71180-003_05576e70-fad7-4d3e-8575-ce5ff28750a8
NDC71180-003
Product TypeHuman Prescription Drug
Proprietary NameRhofade
Generic NameOxymetazoline Hydrochloride
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2017-01-18
Marketing CategoryNDA / NDA
Application NumberNDA208552
Labeler NameAclaris Therapeutics, Inc.
Substance NameOXYMETAZOLINE HYDROCHLORIDE
Active Ingredient Strength1 g/100g
Pharm ClassesVasoconstrictor [EPC],Vasoconstriction [PE],Increased Sympathetic Activity [PE],Imidazolines [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 71180-003-15

3 g in 1 TUBE (71180-003-15)
Marketing Start Date2017-01-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71180-003-30 [71180000330]

Rhofade CREAM
Marketing CategoryNDA
Application NumberNDA208552
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2017-01-18

NDC 71180-003-15 [71180000315]

Rhofade CREAM
Marketing CategoryNDA
Application NumberNDA208552
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-18

NDC 71180-003-60 [71180000360]

Rhofade CREAM
Marketing CategoryNDA
Application NumberNDA208552
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-18

NDC 71180-003-45 [71180000345]

Rhofade CREAM
Marketing CategoryNDA
Application NumberNDA208552
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-18

NDC 71180-003-35 [71180000335]

Rhofade CREAM
Marketing CategoryNDA
Application NumberNDA208552
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-18

NDC 71180-003-65 [71180000365]

Rhofade CREAM
Marketing CategoryNDA
Application NumberNDA208552
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-18

Drug Details

Active Ingredients

IngredientStrength
OXYMETAZOLINE HYDROCHLORIDE1 g/100g

OpenFDA Data

SPL SET ID:8968299e-2a4f-41a8-9088-6343ea6c91f4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1869821
  • 1869816
    • UPC Code
  • 0371180003304

    • Pharmacological Class

    • Vasoconstrictor [EPC]
    • Vasoconstriction [PE]
    • Increased Sympathetic Activity [PE]
    • Imidazolines [CS]

    NDC Crossover Matching brand name "Rhofade" or generic name "Oxymetazoline Hydrochloride"

    NDCBrand NameGeneric Name
    0023-5300RHOFADEOxymetazoline Hydrochloride
    71180-003RhofadeRhofade
    71403-003RhofadeRhofade
    10202-3047 Select Nasaloxymetazoline hydrochloride
    10202-8497 Select Original NasalOxymetazoline Hydrochloride
    11523-1159AfrinOxymetazoline hydrochloride
    11523-0073Afrin Allergy Sinus Nasaloxymetazoline hydrochloride
    11523-1160Afrin No Drip Nightoxymetazoline hydrochloride
    11523-0034Afrin NoDrip Allergy Sinus Nightoxymetazoline hydrochloride
    0363-0304Anefrin Nasaloxymetazoline hydrochloride
    0113-7388basic care nasalOxymetazoline Hydrochloride
    0113-7494basic care no drip nasalOxymetazoline hydrochloride
    11523-0091Children Afrin Extra Moisturizing Stuffy Nose Pump MistOxymetazoline hydrochloride
    11523-0090Children Afrin No Drip Extra Moisturizing Stuffy Nose Pump MistOxymetazoline hydrochloride
    0573-1191DRISTAN 12 HRoxymetazoline hydrochloride
    0113-0304Good Sense Nasaloxymetazoline hydrochloride
    0113-0817Good Sense Nasaloxymetazoline hydrochloride
    0113-2304Nasaloxymetazoline hydrochloride
    0904-5711NasalOxymetazoline Hydrochloride
    0536-5005Nasal ReliefOxymetazoline Hydrochloride
    0363-7007No Drip Anefrin NasalOXYMETAZOLINE HYDROCHLORIDE
    0363-2021Severe AnefrinOXYMETAZOLINE HYDROCHLORIDE
    0363-7009Severe Sinus Relief Mistoxymetazoline hydrochloride
    10237-464Zicam Extreme Congestion Reliefoxymetazoline hydrochloride
    10237-471Zicam Intense Sinus Reliefoxymetazoline hydrochloride

    Trademark Results [Rhofade]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    RHOFADE
    RHOFADE
    86306966 5232934 Live/Registered
    EPI HEALTH, LLC
    2014-06-11
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