FDA.reportPublic FDA data

VICKS SINEX SEVERE CONGESTION

Product NDC
64336-003
11-digit product format
643360003
Labeler code
64336
Product ID
64336-003_5ce119b7-e871-ce49-e063-6294a90a2348
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
2026-02-27
Substance
OXYMETAZOLINE HYDROCHLORIDE
Active strength
.0005 g/mL
Pharmacologic classes
Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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 CONGESTION
Brand name suffix
ORIGINAL Ultra Fine Mist
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYMETAZOLINE HYDROCHLORIDE.0005 g/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64336-003-01VICKS SINEX SEVERE CONGESTIONORIGINAL Ultra Fine Mist15 mL in 1 BOTTLE, SPRAYSPRAY154
64336-003-01VICKS SINEX SEVERE CONGESTIONORIGINAL Ultra Fine Mist1 in 1 CARTONSPRAY14
64336-003-02VICKS SINEX SEVERE CONGESTIONORIGINAL Ultra Fine Mist2 in 1 CARTONSPRAY24
64336-003-02VICKS SINEX SEVERE CONGESTIONORIGINAL Ultra Fine Mist15 mL in 1 BOTTLE, SPRAYSPRAY154

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 163 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Theraflu Severe Cold Relief Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCLHaleon US Holdings LLC682c5a4b-5ded-4276-903f-1ef1141ae5182024-06-01WarningsExact identifier
application number: M012
Maximum Strength Nasal DecongestantOXYMETAZOLINE SPRAYCVS Healthdf1f8bda-7bf3-4755-9169-f2a81d824cbe2024-05-31WarningsExact identifier
application number: M012
No Drip Nasal MistOXYMETAZOLINE SPRAYCVS Healtha78d29ed-019b-4014-ae6f-c60c75d19c892024-05-31WarningsExact identifier
application number: M012
Leader Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDECardinal Health 110,Inc6594c117-6ffc-4bda-8bbf-e91c810f2c3f2024-05-31WarningsExact identifier
application number: M012
Nighttime Cold and Flu Relief Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEUnited Natural Foods, Inc. dba UNFI1aba9b7c-8328-4a9f-8ce2-39648b2d8ae42024-05-23WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIfdf63308-fe7b-4613-a012-ed5e4c9f8ffe2024-05-23WarningsExact identifier
application number: M012
Mucus Relief Cold Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIe61ab02d-f932-403f-a4f7-0ca3546072232024-05-23WarningsExact identifier
application number: M012
Daytime Cold and Flu Relief Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFIe4f9a846-ab72-4508-b0c5-f7911af2f3d72024-05-23WarningsExact identifier
application number: M012
Adult Cough ReliefDEXTROMETHORPHAN HBRQUALITY CHOICE (Chain Drug Marketing Association)6e35f30d-9b29-4468-9f5e-1ee2e9ac4b8c2024-05-20WarningsExact identifier
application number: M012
Chlorpheniramine Maleate 4 mgCHLORPHENIRAMINE MALEATEBryant Ranch Prepack54681242-c861-4415-b5c0-d3ab55b62be12024-05-17WarningsExact identifier
application number: M012
Dibromm Cold and AllergyBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLQUALITY CHOICE (Chain Drug Marketing Association)c830b18b-4427-4530-9bc7-85c2735080d22024-05-17WarningsExact identifier
application number: M012
Childrens Cold and Cough NighttimeDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLSafeway, Inc.cbbec807-f882-4c6a-b1cd-c7fd5ce70cad2024-05-15WarningsExact identifier
application number: M012
Cold and Flu Relief NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESafeway, Inc.d6ac0d70-0511-4ec8-bb35-8b2e0e3d77422024-05-15WarningsExact identifier
application number: M012
Night Time CoughDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESafeway, Inc.f658a03b-6fc2-4b63-b3ab-7e886fbf20b42024-05-15WarningsExact identifier
application number: M012
AXIV DM MaxDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINVIVUNT PHARMA LLC18704e66-ee8f-315d-e063-6294a90a52822024-05-14WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOLTarget Corporation Inc.187622dc-ecde-181d-e063-6294a90a4e8f2024-05-14WarningsExact identifier
application number: M012
Lemon Mint DropsMENTHOLTarget Corporation Inc.1876df19-398a-23d8-e063-6394a90ae7e82024-05-14WarningsExact identifier
application number: M012
Cold Flu and Sore Throat Relief Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLSafeway, Inc.6c952c81-c8b6-4e74-abd8-781f6f44736b2024-05-14WarningsExact identifier
application number: M012
Pain and Sinus RelieverACETAMINOPHEN AND PHENYLEPHRINEJHK DBA American Safety & First Aid249373c6-f56f-4bd3-9cef-98b7ee73457d2024-05-14WarningsExact identifier
application number: M012
NasalPHENYLEPHRINE HYDROCHLORIDEMeijer, Inc.fea71cb9-e044-4729-ad26-1db0cdb9dd112024-05-14WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN4645336e-40d8-89e6-e063-6294a90a76554
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD4645336e-40d8-89e6-e063-6294a90a76554
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY4645336e-40d8-89e6-e063-6294a90a76554

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
64336-003-01643360003011 BOTTLE, SPRAY in 1 CARTON (64336-003-01) / 15 mL in 1 BOTTLE, SPRAY2026-02-27NoNoCurrent
64336-003-02643360003022 BOTTLE, SPRAY in 1 CARTON (64336-003-02) / 15 mL in 1 BOTTLE, SPRAY2026-06-01NoNoCurrent