FDA.reportPublic FDA data

oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Sinex Long-Acting]

RxCUI
1001066
RxNorm name
oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Sinex Long-Acting]
Display name
SINEX LONG-ACTING (Nasal)
Full name
oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Sinex Long-Acting]
Term type
SBD
Status
Active
Strength
0.05%
Dose form
Spray
Route
Nasal
Updated
2026-10-27 17:45:48

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_STRSinex Long-Acting 0.5 MG/ML Nasal Spray1NAMES
RxNorm Nameoxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Sinex Long-Acting]1NAMES
RxNorm Synonym
4 linked values
4NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID
3 linked values
3CODES
RxCUI10010661CODES
MMSL_CODEBD43991CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
64336-170-0164336-170Vicks Sinex Severe Oxymetazoline HydrochlorideProcter & Gamble Manufacturing GmbHM012
64336-171-0164336-171Vicks Sinex SEVERE Oxymetazoline HydrochlorideProcter & Gamble Manufacturing GmbH,M012
64336-171-0264336-171Vicks Sinex SEVERE Oxymetazoline HydrochlorideProcter & Gamble Manufacturing GmbH,M012
64336-173-0164336-173Vicks Sinex SEVERE Oxymetazoline HydrochlorideProcter & Gamble Manufacturing GmbHM012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01264336-170Vicks Sinex Severe Oxymetazoline HydrochlorideOTC MONOGRAPH DRUGProcter & Gamble Manufacturing GmbH

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 31 matching rows.

NDC11, Source, Active table
NDC11SourceActive
23900001252rxnav_ndcsyes
23900001253rxnav_ndcsyes
23900001254rxnav_ndcsyes
23900002293rxnav_ndcsyes
23900002325rxnav_ndcsyes
23900002326rxnav_ndcsyes
37000043201rxnav_ndcsyes
37000043301rxnav_ndcsyes
37000052701rxnav_ndcsyes
37000080201rxnav_ndcsyes
37000080301rxnav_ndcsyes
64336017001rxnav_ndcsyes
64336017101rxnav_ndcsyes
64336017102rxnav_ndcsyes
64336017301rxnav_ndcsyes
23900000132rxnav_historical
23900001301rxnav_historical
23900001310rxnav_historical
23900001320rxnav_historical
37000017001rxnav_historical
37000043302rxnav_historical
37000043401rxnav_historical
37000043501rxnav_historical
37000054205rxnav_historical
37000054305rxnav_historical
37000059901rxnav_historical
37000080101rxnav_historical
64336017201rxnav_historical
64336068201rxnav_historical
64336068301rxnav_historical
64336068501rxnav_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
Vicks Sinex SEVERE ORIGINAL ULTRA FINE MISTOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbH,cfd43b8f-8064-6b88-e053-2a95a90a329e2026-04-22WarningsExact identifier
ndc (package): 64336-171-02
ndc (package): 64336-171-01
ndc (product): 64336-171
ndc11 (package): 64336017101
ndc11 (package): 64336017102
rxcui: 1001066
Vicks Sinex Severe OriginalOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbHcfd048c9-2f33-101d-e053-2995a90ad8542026-04-22WarningsExact identifier
ndc (package): 64336-170-01
ndc (product): 64336-170
ndc11 (package): 64336017001
rxcui: 1001066
Vicks Sinex SEVERE VapoCOOL ULTRA FINE MISTOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbHd0768332-7c24-7c30-e053-2a95a90a26d42026-04-22WarningsExact identifier
ndc (package): 64336-173-01
ndc (product): 64336-173
ndc11 (package): 64336017301
rxcui: 1001066

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
cfd43b8f-8064-6b88-e053-2a95a90a329eVicks Sinex 12Hr Decongestant 0.05 % Nasal Spray [PSN] · oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Sinex Long-Acting] [SBD] · Sinex Long-Acting 0.5 MG/ML Nasal Spray [SY] · Vicks Sinex 12-HR Decongestant 0.05 % Nasal Spray [SY] · Vicks Sinex 12-HR Ultra Fine Moisturizing 0.05 % Nasal Spray [SY] · Vicks Sinex Long-Acting 0.05 % Nasal Spray [SY]69Vicks ® Sinex™ SEVERE Oxymetazoline HCl | Nasal Decongestant ORIGINAL ULTRA FINE MIST20260422
d0768332-7c24-7c30-e053-2a95a90a26d4Vicks Sinex 12Hr Decongestant 0.05 % Nasal Spray [PSN] · oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Sinex Long-Acting] [SBD] · Sinex Long-Acting 0.5 MG/ML Nasal Spray [SY] · Vicks Sinex 12-HR Decongestant 0.05 % Nasal Spray [SY] · Vicks Sinex 12-HR Ultra Fine Moisturizing 0.05 % Nasal Spray [SY] · Vicks Sinex Long-Acting 0.05 % Nasal Spray [SY]69Vicks ® Severe Sinex™ VapoCOOL CONGESTION RELIEF20260422
cfd048c9-2f33-101d-e053-2995a90ad854Vicks Sinex 12Hr Decongestant 0.05 % Nasal Spray [PSN] · oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Sinex Long-Acting] [SBD] · Sinex Long-Acting 0.5 MG/ML Nasal Spray [SY] · Vicks Sinex 12-HR Decongestant 0.05 % Nasal Spray [SY] · Vicks Sinex 12-HR Ultra Fine Moisturizing 0.05 % Nasal Spray [SY] · Vicks Sinex Long-Acting 0.05 % Nasal Spray [SY]68Vicks ® Sinex™ Severe Original Nasal Spray20260422

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
d0768332-7c24-7c30-e053-2a95a90a26d4Vicks ® Severe Sinex™ VapoCOOL CONGESTION RELIEFProcter & Gamble Manufacturing GmbH20260422
cfd43b8f-8064-6b88-e053-2a95a90a329eVicks ® Sinex™ SEVERE Oxymetazoline HCl | Nasal Decongestant ORIGINAL ULTRA FINE MISTProcter & Gamble Manufacturing GmbH,20260422
cfd048c9-2f33-101d-e053-2995a90ad854Vicks ® Sinex™ Severe Original Nasal SprayProcter & Gamble Manufacturing GmbH20260422
cfd048c9-2f33-101d-e053-2995a90ad854Vicks ® Sinex™ Severe Original Nasal SprayProcter & Gamble Manufacturing GmbH20251210
d0768332-7c24-7c30-e053-2a95a90a26d4Vicks ® Severe Sinex™ VapoCOOL CONGESTION RELIEFProcter & Gamble Manufacturing GmbH20251203
cfd43b8f-8064-6b88-e053-2a95a90a329eVicks ® Sinex™ SEVERE Oxymetazoline HCl | Nasal Decongestant ORIGINAL ULTRA FINE MISTProcter & Gamble Manufacturing GmbH,20251203
cfd43b8f-8064-6b88-e053-2a95a90a329eVicks ® Sinex™ SEVERE Oxymetazoline HCl | Nasal Decongestant ORIGINAL ULTRA FINE MISTProcter & Gamble Manufacturing GmbH,20251001
d0768332-7c24-7c30-e053-2a95a90a26d4Vicks ® Severe Sinex™ VapoCOOL CONGESTION RELIEFProcter & Gamble Manufacturing GmbH20251001
cfd048c9-2f33-101d-e053-2995a90ad854Vicks ® Sinex™ Severe Original Nasal SprayProcter & Gamble Manufacturing GmbH20251001
8aa95112-c538-4a55-ab40-ad164d752dd4Vicks ® Sinex™ SEVERE MOISTURIZING ULTRA FINE MISTThe Procter & Gamble Manufacturing Company20231016
a3503f25-c158-478b-87c6-b218961aa5f2Vicks ®Sinex™ SEVERE Oxymetazoline HCl | Nasal Decongestant ORIGINAL ULTRA FINE MISTThe Procter & Gamble Manufacturing Company20231016
7d50b4d8-1f92-7898-e053-2a91aa0a241dVicks ® Sinex™ Severe Original Nasal SprayThe Procter & Gamble Manufacturing Company20231016
facaea70-28aa-7a9d-e053-6394a90aa5bfVicks ® Severe Sinex™ VapoCOOL 12 HOUR DECONGESTANT ULTRA FINE MISTThe Procter & Gamble Manufacturing Company20231016
6f2b46cd-59c5-4196-e053-2991aa0a61cbVicks ® Sinex™ Severe No Drip Nasal SprayThe Procter & Gamble Manufacturing Company20221209
cfe0e0a6-cec8-b027-e053-2995a90a96aaVicks ® Sinex™ MoisturizingProcter & Gamble Manufacturing GmbH20221207
6e736035-eb66-412f-9b23-b6f490ffdb2cVicks ® Sinex™ Scent FreeThe Procter & Gamble Manufacturing Company20191216
6d8ee14e-570f-4be6-8231-7bde6d823914Vicks ® Sinex™ SEVERE Nasal SprayThe Procter & Gamble Manufacturing Company20190625

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_STRENGTH0.5 MG/ML
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
NAMESPrescribable SynonymVicks Sinex 12Hr Decongestant 0.05 % Nasal Spray
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon