FDA.reportPublic FDA data

oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Sudafed OM]

RxCUI
1001081
RxNorm name
oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Sudafed OM]
Display name
SUDAFED OM (Nasal)
Full name
oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Sudafed OM]
Term type
SBD
Status
Active
Strength
0.05%
Dose form
Spray
Route
Nasal
Updated
2026-10-27 17:45:52

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
092010
Active start
092010
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
oxymetazoline hydrochloride0.5 MG / 1 MLoxymetazolineoxymetazoline hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Nasal Spray126542

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
oxymetazoline7812

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRSudafed OM 0.05 % Nasal Spray1NAMES
RxNorm Nameoxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Sudafed OM]1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID
3 linked values
3CODES
RxCUI10010811CODES
MMSL_CODEBD43991CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
50580-364-0150580-364SUDAFED OM Sinus Severe No Drip Nasal Mist Oxymetazoline HydrochlorideKenvue Brands LLCM012
50580-368-0150580-368SUDAFED OM Sinus Severe No Drip Nasal Mist with Cooling Menthol Oxymetazoline HydrochlorideKenvue Brands LLCM012
50580-787-0150580-787SUDAFED OM Sinus Severe Original Oxymetazoline HydrochlorideKenvue Brands LLCM012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01250580-364SUDAFED OM Sinus Severe No Drip Nasal Mist Oxymetazoline HydrochlorideOTC MONOGRAPH DRUGKenvue Brands LLC

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 6 matching rows.

NDC11, Source, Active table
NDC11SourceActive
50580036401rxnav_ndcsyes
50580036801rxnav_ndcsyes
50580078701rxnav_ndcsyes
00045052805rxnav_historical
50580052005rxnav_historical
50580052805rxnav_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
SUDAFED OM Sinus Severe No Drip Nasal Mist with Cooling MentholOXYMETAZOLINE HYDROCHLORIDEKenvue Brands LLC33fe0e49-3de5-8afd-e063-6294a90a0ad52025-05-02WarningsExact identifier
ndc (package): 50580-368-01
ndc (product): 50580-368
ndc11 (package): 50580036801
rxcui: 1001081
SUDAFED OM Sinus Severe No Drip Nasal MistOXYMETAZOLINE HYDROCHLORIDEKenvue Brands LLC33e6239b-364a-0e62-e063-6294a90a50472025-04-29WarningsExact identifier
ndc (package): 50580-364-01
ndc (product): 50580-364
ndc11 (package): 50580036401
rxcui: 1001081
SUDAFED OM Sinus Severe OriginalOXYMETAZOLINE HYDROCHLORIDEKenvue Brands LLC1d089074-3969-ce6e-e063-6294a90aa70c2024-12-12WarningsExact identifier
ndc (package): 50580-787-01
ndc (product): 50580-787
ndc11 (package): 50580078701
rxcui: 1001081

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
1d089074-3969-ce6e-e063-6294a90aa70cSudafed OM 0.05 % Nasal Spray [PSN] · oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Sudafed OM] [SBD] · Sudafed OM 0.05 % Nasal Spray [SY] · Sudafed OM 0.5 MG/ML Nasal Spray [SY]42SUDAFED® OM Sinus Severe Original Nasal Spray20241212
33fe0e49-3de5-8afd-e063-6294a90a0ad5Sudafed OM 0.05 % Nasal Spray [PSN] · oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Sudafed OM] [SBD] · Sudafed OM 0.05 % Nasal Spray [SY] · Sudafed OM 0.5 MG/ML Nasal Spray [SY]41SUDAFED® OM Sinus Severe No Drip Nasal Mist with Cooling Menthol20250502
33e6239b-364a-0e62-e063-6294a90a5047Sudafed OM 0.05 % Nasal Spray [PSN] · oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Sudafed OM] [SBD] · Sudafed OM 0.05 % Nasal Spray [SY] · Sudafed OM 0.5 MG/ML Nasal Spray [SY]41SUDAFED® OM Sinus Severe No Drip Nasal Mist20250429

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
33fe0e49-3de5-8afd-e063-6294a90a0ad5SUDAFED® OM Sinus Severe No Drip Nasal Mist with Cooling MentholKenvue Brands LLC20250502
33e6239b-364a-0e62-e063-6294a90a5047SUDAFED® OM Sinus Severe No Drip Nasal MistKenvue Brands LLC20250429
1d089074-3969-ce6e-e063-6294a90aa70cSUDAFED® OM Sinus Severe Original Nasal SprayKenvue Brands LLC20241212
6ae1db60-c2f7-4765-ac77-35e1273f47d0National Council for Prescription Drug Programs20120724

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
ATTRIBUTESACTIVATED10/01/2024
ATTRIBUTESAVAILABLE_STRENGTH0.5 MG/ML
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
NAMESPrescribable SynonymSudafed OM 0.05 % Nasal Spray
SOURCESSourceMetathesaurus FDA Structured Product Labels