FDA.reportPublic FDA data

oxymetazoline hydrochloride 10 MG/ML Topical Cream

RxCUI
1869816
RxNorm name
oxymetazoline hydrochloride 10 MG/ML Topical Cream
Display name
Oxymetazoline (Topical)
Full name
oxymetazoline hydrochloride 10 MG/ML Topical Cream
Term type
SCD
Status
Active
Strength
1%
Dose form
Cream
Route
Topical
Updated
2026-10-27 17:50:04

RxNorm Status History#

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

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_STRoxymetazoline hydrochloride 10 MG/ML Topical Cream1NAMES
RxNorm Nameoxymetazoline hydrochloride 10 MG/ML Topical Cream1NAMES
RxNorm Synonymoxymetazoline HCl 1 % Topical Cream1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID8a7f2400-5e18-4215-8d2c-f558817061071CODES
RxCUI18698161CODES
MMSL_CODE
2 linked values
2CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
51672-1405-251672-1405Oxymetazoline Hydrochloride Oxymetazoline HydrochlorideSun Pharmaceutical Industries, Inc.ANDA213584
51672-1405-351672-1405Oxymetazoline Hydrochloride Oxymetazoline HydrochlorideSun Pharmaceutical Industries, Inc.ANDA213584
68308-766-3068308-766Rhofade oxymetazoline hydrochlorideMayne PharmaNDA208552

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA21358451672-1405Oxymetazoline Hydrochloride Oxymetazoline HydrochlorideANDASun Pharmaceutical Industries, Inc.
NDA20855268308-766Rhofade oxymetazoline hydrochlorideNDAMayne Pharma

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 3 matching rows.

NDC11, Source, Active table
NDC11SourceActive
51672140502rxnav_ndcsyes
51672140503rxnav_ndcsyes
68308076630rxnav_ndcsyes

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RhofadeOXYMETAZOLINE HYDROCHLORIDEMayne Pharma34298db6-647d-480d-88a8-dc53258a51642026-07-13Warnings, Adverse reactionsExact identifier
ndc (package): 68308-766-30
ndc (product): 68308-766
ndc11 (package): 68308076630
rxcui: 1869816
Oxymetazoline HydrochlorideOXYMETAZOLINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.8a7f2400-5e18-4215-8d2c-f558817061072026-05-08Warnings, Adverse reactionsExact identifier
ndc (package): 51672-1405-3
ndc (package): 51672-1405-2
ndc (product): 51672-1405
ndc11 (package): 51672140502
ndc11 (package): 51672140503
rxcui: 1869816
RhofadeOXYMETAZOLINE HYDROCHLORIDEMayne Pharmaf7dbf12e-a802-4261-bae2-c209776989332025-06-27Warnings, Adverse reactionsExact identifier
rxcui: 1869816
RhofadeOXYMETAZOLINE HYDROCHLORIDEEPI Health, LLCe82b5788-a855-4165-a81f-7f15cb8746122023-05-09Warnings, Adverse reactionsExact identifier
rxcui: 1869816

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-41a8-9088-6343ea6c91f4oxymetazoline HCl 1 % Topical Cream [PSN] · oxymetazoline hydrochloride 10 MG/ML Topical Cream [SCD] · oxymetazoline HCl 1 % Topical Cream [SY]33These 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-c20977698933oxymetazoline HCl 1 % Topical Cream [PSN] · oxymetazoline hydrochloride 10 MG/ML Topical Cream [SCD] · oxymetazoline HCl 1 % Topical Cream [SY]32These 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-7f15cb874612oxymetazoline HCl 1 % Topical Cream [PSN] · oxymetazoline hydrochloride 10 MG/ML Topical Cream [SCD] · oxymetazoline HCl 1 % Topical Cream [SY]32These 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
8a7f2400-5e18-4215-8d2c-f55881706107These highlights do not include all the information needed to use OXYMETAZOLINE HYDROCHLORIDE TOPICAL CREAM safely and effectively. See full prescribing information for OXYMETAZOLINE HYDROCHLORIDE TOPICAL CREAM OXYMETAZOLINE HYDROCHLORIDE cream, for topical use Initial U.S. Approval: 1964Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.20260508

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
CODESANDAANDA213584
CODESVUID4036487
NAMESPrescribable Synonymoxymetazoline HCl 1 % Topical Cream
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceVeterans Health Administration National Drug File