FDA.reportPublic FDA data

oxymetazoline hydrochloride 10 MG/ML Topical Cream [Rhofade]

RxCUI
1869821
RxNorm name
oxymetazoline hydrochloride 10 MG/ML Topical Cream [Rhofade]
Display name
RHOFADE (Topical)
Full name
oxymetazoline hydrochloride 10 MG/ML Topical Cream [Rhofade]
Term type
SBD
Status
Active
Strength
1%
Dose form
Cream
Route
Topical
Updated
2026-10-27 19:27:59

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
032017
Active start
032017
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
oxymetazoline hydrochloride10 MG / 1 MLoxymetazolineoxymetazoline hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Topical Cream316982

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
oxymetazoline7812

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRRhofade 1 % Topical Cream1NAMES
RxNorm Nameoxymetazoline hydrochloride 10 MG/ML Topical Cream [Rhofade]1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID
3 linked values
3CODES
RxCUI18698211CODES
MMSL_CODEBD317411CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
51862-765-0051862-765Rhofade oxymetazoline hydrochlorideMayne PharmaNDA208552
51862-765-3051862-765Rhofade oxymetazoline hydrochlorideMayne PharmaNDA208552
71403-003-1571403-003Rhofade OXYMETAZOLINE HYDROCHLORIDEEPI Health, LLCNDA208552
71403-003-3071403-003Rhofade OXYMETAZOLINE HYDROCHLORIDEEPI Health, LLCNDA208552

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA20855251862-765Rhofade oxymetazoline hydrochlorideNDAMayne Pharma

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 15 matching rows.

NDC11, Source, Active table
NDC11SourceActive
51862076500rxnav_ndcsyes
51862076530rxnav_ndcsyes
71180000330rxnav_ndcsyes
71403000315rxnav_ndcsyes
71403000330rxnav_ndcsyes
00023530030rxnav_historical
00023530035rxnav_historical
00023530060rxnav_historical
00023530065rxnav_historical
68308076630rxnav_historical
71180000315rxnav_historical
71180000335rxnav_historical
71180000345rxnav_historical
71180000360rxnav_historical
71180000365rxnav_historical

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RhofadeOXYMETAZOLINE HYDROCHLORIDEMayne Pharma34298db6-647d-480d-88a8-dc53258a51642026-07-13Warnings, Adverse reactionsExact identifier
ndc11 (package): 68308076630
rxcui: 1869821
RhofadeOXYMETAZOLINE HYDROCHLORIDEMayne Pharmaf7dbf12e-a802-4261-bae2-c209776989332025-06-27Warnings, Adverse reactionsExact identifier
ndc (package): 51862-765-00
ndc (package): 51862-765-30
ndc (product): 51862-765
ndc11 (package): 51862076500
ndc11 (package): 51862076530
rxcui: 1869821
RhofadeOXYMETAZOLINE HYDROCHLORIDEEPI Health, LLCe82b5788-a855-4165-a81f-7f15cb8746122023-05-09Warnings, Adverse reactionsExact identifier
ndc (package): 71403-003-15
ndc (package): 71403-003-30
ndc (product): 71403-003
ndc11 (package): 71403000315
ndc11 (package): 71403000330
rxcui: 1869821

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 3 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
8968299e-2a4f-41a8-9088-6343ea6c91f4Rhofade 1 % Topical Cream [PSN] · oxymetazoline hydrochloride 10 MG/ML Topical Cream [Rhofade] [SBD] · Rhofade 1 % Topical Cream [SY] · Rhofade 10 MG/ML Topical Cream [SY]43These highlights do not include all the information needed to use RHOFADE ® topical cream safely and effectively. See full prescribing information for RHOFADE ® topical cream. RHOFADE ® (oxymetazoline hydrochloride) cream, 1%, for topical use Initial U.S. Approval: 196420191031
f7dbf12e-a802-4261-bae2-c20977698933Rhofade 1 % Topical Cream [PSN] · oxymetazoline hydrochloride 10 MG/ML Topical Cream [Rhofade] [SBD] · Rhofade 1 % Topical Cream [SY] · Rhofade 10 MG/ML Topical Cream [SY]42These highlights do not include all the information needed to use RHOFADE ® topical cream safely and effectively. See full prescribing information for RHOFADE ® topical cream. RHOFADE ® (oxymetazoline hydrochloride) cream, 1%, for topical use Initial U.S. Approval: 196420250627
e82b5788-a855-4165-a81f-7f15cb874612Rhofade 1 % Topical Cream [PSN] · oxymetazoline hydrochloride 10 MG/ML Topical Cream [Rhofade] [SBD] · Rhofade 1 % Topical Cream [SY] · Rhofade 10 MG/ML Topical Cream [SY]42These highlights do not include all the information needed to use RHOFADE ® topical cream safely and effectively. See full prescribing information for RHOFADE ® topical cream. RHOFADE ® (oxymetazoline hydrochloride) cream, 1%, for topical use Initial U.S. Approval: 196420230509

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
34298db6-647d-480d-88a8-dc53258a5164These highlights do not include all the information needed to use Oxymetazoline Hydrochloride Cream safely and effectively. See full prescribing information for Oxymetazoline Hydrochloride Cream. Oxymetazoline Hydrochloride Cream, 1%, for topical use Initial U.S. Approval: 1964Mayne Pharma | DPT Laboratories, Ltd.20260713
f7dbf12e-a802-4261-bae2-c20977698933These highlights do not include all the information needed to use RHOFADE ® topical cream safely and effectively. See full prescribing information for RHOFADE ® topical cream. RHOFADE ® (oxymetazoline hydrochloride) cream, 1%, for topical use Initial U.S. Approval: 1964Mayne Pharma | DPT Laboratories, Ltd.20250627
e82b5788-a855-4165-a81f-7f15cb874612These highlights do not include all the information needed to use RHOFADE ® topical cream safely and effectively. See full prescribing information for RHOFADE ® topical cream. RHOFADE ® (oxymetazoline hydrochloride) cream, 1%, for topical use Initial U.S. Approval: 1964EPI Health, LLC | DPT Laboratories, Ltd.20230509
8968299e-2a4f-41a8-9088-6343ea6c91f4These highlights do not include all the information needed to use RHOFADE ® topical cream safely and effectively. See full prescribing information for RHOFADE ® topical cream. RHOFADE ® (oxymetazoline hydrochloride) cream, 1%, for topical use Initial U.S. Approval: 1964Aclaris Therapeutics, Inc. | DPT Laboratories, Ltd.20191031
1ba1cc5b-4f7f-491b-a5af-a6a14fb5affdThese highlights do not include all the information needed to use RHOFADE ™ topical c ream safely and effectively. See full prescribing information for RHOFADE ™ topical c ream . RHOFADE ™ ( oxymetazoline hydrochloride ) cream , for topical use Initial U.S. Approval: 1964Allergan, Inc. | DPT Laboratories, Ltd.20170101

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCD11AXOther dermatologicalsATC1-4oxymetazoline
ATCS01GASympathomimetics used as decongestantsATC1-4oxymetazoline
ATCR01ABSympathomimetics, combinations excl. corticosteroidsATC1-4oxymetazoline
ATCR01AASympathomimetics, plainATC1-4oxymetazoline
FDASPLD048288ImidazolinesCHEMhas_chemical_structureoxymetazoline
FDASPLN0000192562VasoconstrictorEPChas_epcoxymetazoline
FDASPLN0000175651Increased Sympathetic ActivityPEhas_peoxymetazoline
FDASPLN0000009908VasoconstrictionPEhas_peoxymetazoline
MEDRTD010109OxymetazolineCHEMhas_ingredientoxymetazoline hydrochloride
MEDRTD010109OxymetazolineCHEMhas_ingredientoxymetazoline
MEDRTD003139Common ColdDISEASEmay_treatoxymetazoline hydrochloride
MEDRTD003139Common ColdDISEASEmay_treatoxymetazoline
MEDRTD003231ConjunctivitisDISEASEmay_treatoxymetazoline hydrochloride
MEDRTD003231ConjunctivitisDISEASEmay_treatoxymetazoline
MEDRTD012220RhinitisDISEASEmay_treatoxymetazoline
MEDRTD012220RhinitisDISEASEmay_treatoxymetazoline hydrochloride
MEDRTD012852SinusitisDISEASEmay_treatoxymetazoline
MEDRTD012852SinusitisDISEASEmay_treatoxymetazoline hydrochloride
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moaoxymetazoline
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moaoxymetazoline hydrochloride
MEDRTN0000008371Conjunctival Arterial VasoconstrictionPEhas_peoxymetazoline
MEDRTN0000008371Conjunctival Arterial VasoconstrictionPEhas_peoxymetazoline hydrochloride
MEDRTN0000008896Decreased Nasal and Sinus SecretionsPEhas_peoxymetazoline
MEDRTN0000008896Decreased Nasal and Sinus SecretionsPEhas_peoxymetazoline hydrochloride

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH10 MG/ML
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESNDANDA208552
NAMESPrescribable SynonymRhofade 1 % Topical Cream
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon