FDA.reportPublic FDA data

oxymetazoline hydrochloride 0.1 MG/ACTUAT / tetracaine hydrochloride 6 MG/ACTUAT Metered Dose Nasal Spray [Kovanaze]

RxCUI
1809056
RxNorm name
oxymetazoline hydrochloride 0.1 MG/ACTUAT / tetracaine hydrochloride 6 MG/ACTUAT Metered Dose Nasal Spray [Kovanaze]
Display name
KOVANAZE (Nasal)
Full name
oxymetazoline hydrochloride 0.1 MG/ACTUAT / tetracaine hydrochloride 6 MG/ACTUAT Metered Dose Nasal Spray [Kovanaze]
Term type
SBD
Status
Active
Strength
100-6,000 mcg/puff
Dose form
Metered dose spray
Route
Nasal
Updated
2026-10-24 12:48:19

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
102016
Active start
102016
Multiple ingredient
YES
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
tetracaine hydrochloride6 MG / 1 ACTUATtetracainetetracaine hydrochloride
oxymetazoline hydrochloride0.1 MG / 1 ACTUAToxymetazolineoxymetazoline hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Metered Dose Nasal Spray1797831

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
tetracaine10391
oxymetazoline7812

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRKovanaze (oxymetazoline hydrochloride 0.5 MG/ML / tetracaine hydrochloride 30 MG/ML) Metered Dose Nasal Spray1NAMES
RxNorm Nameoxymetazoline hydrochloride 0.1 MG/ACTUAT / tetracaine hydrochloride 6 MG/ACTUAT Metered Dose Nasal Spray [Kovanaze]1NAMES
RxNorm Synonym
3 linked values
3NAMES
TTYSBD1ATTRIBUTES
RxCUI18090561CODES

RxNav Current And Historical NDCs#

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

NDC11, Source, Active table
NDC11SourceActive
69803010010rxnav_ndcsyes

UNII Substances#

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

No records found.

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 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
d2af5404-3cfe-445d-8328-19e667ecdc43KOVANAZE 0.1 MG / 6 MG in 0.2 ML Metered Dose Nasal Spray [PSN] · oxymetazoline hydrochloride 0.1 MG/ACTUAT / tetracaine hydrochloride 6 MG/ACTUAT Metered Dose Nasal Spray [Kovanaze] [SBD] · Kovanaze (oxymetazoline hydrochloride 0.1 MG / tetracaine hydrochloride 6 MG) per 0.2 ML Metered Dose Nasal Spray [SY] · Kovanaze (oxymetazoline hydrochloride 0.1 MG/ACTUAT / tetracaine hydrochloride 6 MG/ACTUAT) Metered Dose Nasal Spray [SY] · Kovanaze (oxymetazoline hydrochloride 0.5 MG/ML / tetracaine hydrochloride 30 MG/ML) Metered Dose Nasal Spray [SY]58These highlights do not include all the information needed to use KOVANAZE TM NASAL SPRAY safely and effectively. See full prescribing information for KOVANAZE NASAL SPRAY. KOVANAZE (tetracaine HCl and oxymetazoline HCl) Nasal Spray Initial U.S. Approval: 201620181116

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
d2af5404-3cfe-445d-8328-19e667ecdc43These highlights do not include all the information needed to use KOVANAZE TM NASAL SPRAY safely and effectively. See full prescribing information for KOVANAZE NASAL SPRAY. KOVANAZE (tetracaine HCl and oxymetazoline HCl) Nasal Spray Initial U.S. Approval: 2016St. Renatus20181116

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCD04ABAnesthetics for topical useATC1-4tetracaine
ATCN01BAEsters of aminobenzoic acidATC1-4tetracaine
ATCC05ADLocal anestheticsATC1-4tetracaine
ATCS01HALocal anestheticsATC1-4tetracaine
ATCD11AXOther dermatologicalsATC1-4oxymetazoline
ATCS01GASympathomimetics used as decongestantsATC1-4oxymetazoline
ATCR01ABSympathomimetics, combinations excl. corticosteroidsATC1-4oxymetazoline
ATCR01AASympathomimetics, plainATC1-4oxymetazoline
FDASPLD004952EstersCHEMhas_chemical_structuretetracaine
FDASPLD048288ImidazolinesCHEMhas_chemical_structureoxymetazoline
FDASPLN0000175683Ester Local AnestheticEPChas_epctetracaine
FDASPLN0000192562VasoconstrictorEPChas_epcoxymetazoline
FDASPLN0000175651Increased Sympathetic ActivityPEhas_peoxymetazoline
FDASPLN0000175976Local AnesthesiaPEhas_petetracaine
FDASPLN0000009908VasoconstrictionPEhas_peoxymetazoline
MEDRTD010109OxymetazolineCHEMhas_ingredientoxymetazoline
MEDRTD010109OxymetazolineCHEMhas_ingredientoxymetazoline hydrochloride
MEDRTD013748TetracaineCHEMhas_ingredienttetracaine
MEDRTD003139Common ColdDISEASEmay_treatoxymetazoline hydrochloride
MEDRTD003139Common ColdDISEASEmay_treatoxymetazoline
MEDRTD003231ConjunctivitisDISEASEmay_treatoxymetazoline hydrochloride
MEDRTD003231ConjunctivitisDISEASEmay_treatoxymetazoline
MEDRTD004342Drug HypersensitivityDISEASEci_withtetracaine
MEDRTD004342Drug HypersensitivityDISEASEci_withtetracaine hydrochloride
MEDRTD010146PainDISEASEmay_treattetracaine hydrochloride
MEDRTD010146PainDISEASEmay_preventtetracaine hydrochloride
MEDRTD010146PainDISEASEmay_preventtetracaine
MEDRTD010146PainDISEASEmay_treattetracaine
MEDRTD012220RhinitisDISEASEmay_treatoxymetazoline
MEDRTD012220RhinitisDISEASEmay_treatoxymetazoline hydrochloride
MEDRTD012852SinusitisDISEASEmay_treatoxymetazoline hydrochloride
MEDRTD012852SinusitisDISEASEmay_treatoxymetazoline
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moaoxymetazoline
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moaoxymetazoline hydrochloride
MEDRTN0000000180Sodium Channel InteractionsMOAhas_moatetracaine
MEDRTN0000000180Sodium Channel InteractionsMOAhas_moatetracaine hydrochloride
MEDRTN0000008371Conjunctival Arterial VasoconstrictionPEhas_peoxymetazoline
MEDRTN0000008371Conjunctival Arterial VasoconstrictionPEhas_peoxymetazoline hydrochloride
MEDRTN0000008896Decreased Nasal and Sinus SecretionsPEhas_peoxymetazoline
MEDRTN0000008896Decreased Nasal and Sinus SecretionsPEhas_peoxymetazoline hydrochloride
MEDRTN0000008889Decreased Sensory-Somatic Nervous System Organized Electrical ActivityPEhas_petetracaine
MEDRTN0000008889Decreased Sensory-Somatic Nervous System Organized Electrical ActivityPEhas_petetracaine hydrochloride
MEDRTN0000175976Local AnesthesiaPEhas_petetracaine hydrochloride
MEDRTN0000175976Local AnesthesiaPEhas_petetracaine

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH0.1 MG/ACTUAT / 6 MG/ACTUAT
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
NAMESPrescribable SynonymKOVANAZE 0.1 MG / 6 MG in 0.2 ML Metered Dose Nasal Spray