FDA.reportPublic FDA data

Vicks Sinex SEVERE

Product NDC
64336-171
11-digit product format
643360171
Labeler code
64336
Product ID
64336-171_500f4e9a-1229-dc5d-e063-6294a90afe5c
Type
HUMAN OTC DRUG
Nonproprietary name
Oxymetazoline Hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
Procter & Gamble Manufacturing GmbH,
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-04-27
Marketing end
2028-02-28
Substance
OXYMETAZOLINE HYDROCHLORIDE
Active strength
.0005095 g/mL
Pharmacologic classes
Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Vicks Sinex SEVERE
Brand name suffix
ORIGINAL ULTRA FINE MIST

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYMETAZOLINE HYDROCHLORIDE.0005095 g/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K89MJ0S5VYInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1000990Internal RxNorm lookup
1001066Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
cfd43b8f-8064-6b88-e053-2a95a90a329eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64336-171-01Vicks Sinex SEVEREORIGINAL ULTRA FINE MIST15 mL in 1 BOTTLE, PUMPSPRAY159
64336-171-01Vicks Sinex SEVEREORIGINAL ULTRA FINE MIST1 in 1 CARTONSPRAY19
64336-171-02Vicks Sinex SEVEREORIGINAL ULTRA FINE MIST15 mL in 1 BOTTLE, PUMPSPRAY159
64336-171-02Vicks Sinex SEVEREORIGINAL ULTRA FINE MIST2 in 1 CARTONSPRAY29

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64336-171VICKS SINEX 12 HOUR DECONGESTANT ULTRA FINE MIST (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PROCTER & GAMBLE MANUFACTURING GMBH,]6Current NDC, Legacy NDC, 4 package rows20241012_cfd43b8f-8064-6b88-e053-2a95a90a329e.zip

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 59 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vapo SteamVAPO STEAMTOPCO ASSOCIATES, LLCf216f69f-9580-25ac-e053-2995a90a5ac62026-01-14WarningsExact identifier
application number: M012
Leader Vapor Ice Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDECardinal Health 110, LLC. dba Leaderf27bf0b2-25cc-474c-ab6b-f227ed3525fa2026-01-14WarningsExact identifier
application number: M012
Sinus PE plus AllergyCHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCLWalgreen Companya15979d4-87bf-42e7-b1f2-7834960721412026-01-13WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBETTER LIVING BRANDS LLC.41f4bf6d-f83c-92e4-e063-6394a90aebab2026-01-13WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHYVEE INC3e608643-1a74-b474-e063-6294a90ad2e02026-01-13WarningsExact identifier
application number: M012
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC462cbf3d-51b1-dab9-e063-6394a90a70ba2026-01-13WarningsExact identifier
application number: M012
Pocket FarmacyMENTHOLSaje Natural Business Inc.4260542e-0980-4b0b-8177-1c9f2c53b5a62026-01-13WarningsExact identifier
application number: M012
Sweet ComfortMENTHOLSaje Natural Business Inc.cf13cccd-723d-4d61-8a5e-b36281605cc72026-01-13WarningsExact identifier
application number: M012
FortifyMENTHOLSaje Natural Business Inc.0320a305-99d1-4909-94cc-cd6509ecb9482026-01-13WarningsExact identifier
application number: M012
Rolling FarmacyMENTHOLSaje Natural Business Inc.a38765a9-22cd-4fc5-b5ab-c3cacbd52c742026-01-13WarningsExact identifier
application number: M012
Home FarmacyMENTHOLSaje Natural Business Inc.add35d10-b27a-4ae8-b2de-8a285aaef1552026-01-13WarningsExact identifier
application number: M012
Traveling FarmacyMENTHOLSaje Natural Business Inc.5b70f5aa-ed36-65ab-e053-2a91aa0a67772026-01-13WarningsExact identifier
application number: M012
sinus plus allergy PE maximum strengthCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI660d3c80-f249-41dd-aa93-a0b1e635ead02026-01-13WarningsExact identifier
application number: M012
Chest ComfortMENTHOLSaje Natural Business Inc.8a3db169-6dd7-4dfd-8360-90315288f21b2026-01-12WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLH E Bc9e977b6-fba6-49ea-9d80-b43b0842bbe12026-01-12WarningsExact identifier
application number: M012
PE Sinus CongestionPHENYLEPHRINE HCLTopco Associates, LLC3264e291-7a0f-4e25-8390-ba441f22f6502026-01-12WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLCVS PHARMACY3f44cff6-240a-4a8d-aaa1-0da75a31a47b2026-01-12WarningsExact identifier
application number: M012
Suphedrine PE Sinus Congestion Non-DrowsyPHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEb9122fd0-0bed-4302-9bbe-cd6a46d298182026-01-12WarningsExact identifier
application number: M012
Sinu-Phen Plus Sinus Pain and PressureACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEWildman Business Groupc66e0b52-5531-4a84-ae90-8a26d27df1ec2026-01-12WarningsExact identifier
application number: M012
SU PHEDRINE PE SINUS CONGESTIONPHENYLEPHRINE HCLSalado Sales, Inc.ba075ff7-4e26-4856-8335-0c7dd4e198ea2026-01-12WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSNcfd43b8f-8064-6b88-e053-2a95a90a329e9
1001066Vicks Sinex 12Hr Decongestant 0.05 % Nasal SprayPSNcfd43b8f-8064-6b88-e053-2a95a90a329e9
1001066oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Sinex Long-Acting]SBDcfd43b8f-8064-6b88-e053-2a95a90a329e9
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCDcfd43b8f-8064-6b88-e053-2a95a90a329e9
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySYcfd43b8f-8064-6b88-e053-2a95a90a329e9
1001066Sinex Long-Acting 0.5 MG/ML Nasal SpraySYcfd43b8f-8064-6b88-e053-2a95a90a329e9
1001066Vicks Sinex 12-HR Decongestant 0.05 % Nasal SpraySYcfd43b8f-8064-6b88-e053-2a95a90a329e9
1001066Vicks Sinex 12-HR Ultra Fine Moisturizing 0.05 % Nasal SpraySYcfd43b8f-8064-6b88-e053-2a95a90a329e9
1001066Vicks Sinex Long-Acting 0.05 % Nasal SpraySYcfd43b8f-8064-6b88-e053-2a95a90a329e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64336-171-01643360171011 BOTTLE, PUMP in 1 CARTON (64336-171-01) / 15 mL in 1 BOTTLE, PUMP2015-04-272028-02-28NoNoCurrent
64336-171-02643360171022 BOTTLE, PUMP in 1 CARTON (64336-171-02) / 15 mL in 1 BOTTLE, PUMP2015-04-272028-02-28NoNoCurrent