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 151 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALLERGY RELIEFDIPHENHYDRAMINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.9f95715f-63dc-6086-e053-2a95a90adb0c2024-10-15WarningsExact identifier
application number: M012
Allergy MultiSymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.a61636e9-8fe2-8419-e053-2a95a90a011c2024-10-15WarningsExact identifier
application number: M012
SINUS AND HEADACHEACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.9f95b2e8-dea4-ef59-e053-2a95a90a0bcb2024-10-15WarningsExact identifier
application number: M012
Cold Multi-Symptom DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEAmerican Sales Companyd2dcbc7c-e66c-4922-83df-c706a37bf3342024-10-15WarningsExact identifier
application number: M012
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC. (9f958d97-8dcf-332d-e053-2995a90a0a652024-10-15WarningsExact identifier
application number: M012
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDERetail Business Services , LLC.8bc68a71-62c5-a04f-e053-2995a90a92fd2024-10-15WarningsExact identifier
application number: M012
COLD FLU AND SORE THROATACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.9f960566-0158-6637-e053-2995a90a9c4a2024-10-15WarningsExact identifier
application number: M012
HEAD CONGESTION PLUS FLU SEVERE PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.e65cf21d-3d69-a53e-e053-2a95a90a1c832024-10-15WarningsExact identifier
application number: M012
night timeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEH E B49f5f4d3-556c-4ee3-b5cd-5331dd434bb92024-10-15WarningsExact identifier
application number: M012
Mielim y masDEXTROMETHORPHANEfficient Laboratories Inc.711d1dae-3af4-46af-a3a8-cd827356a81a2024-10-14WarningsExact identifier
application number: M012
Tukol Cough and CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USA27ab3d86-e960-4d83-aad1-d50d2c8e02a92024-10-14WarningsExact identifier
application number: M012
HealthWise Chest Rub LavenderCAMPHOR, MENTHOL, EUCALYPTUS OILVeridian Healthcare2472ce85-c701-4fcd-e063-6394a90a27652024-10-14WarningsExact identifier
application number: M012
HealthWise Chest Rub LemonCAMPHOR, MENTHOL, EUCALYPTUS OILVeridian Healthcare24740d5a-aba1-0bd4-e063-6394a90ab2ca2024-10-14WarningsExact identifier
application number: M012
Childrens Plus Cough and Runny NoseACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ea059b56-dc9a-4a6b-8c16-5dfcdaf4cd432024-10-14WarningsExact identifier
application number: M012
Theraflu Severe Cold ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENPHYDRAMINE HCL, GUAIFENESINHaleon US Holdings LLCb01cc9f5-53f2-40d8-acf1-6de180b3d0bf2024-10-14WarningsExact identifier
application number: M012
Cough Relief AdultDEXTROMETHORPHAN HBRDolgencorp, Inc. (DOLLAR GENERAL & REXALL)f5c57b32-69cb-469e-ad2d-64c00b5e66dc2024-10-14WarningsExact identifier
application number: M012
Nasal DecongestantPSEUDOEPHEDRINE HCLPublix Super Markets Inc94c21df5-c631-4748-a833-288b2298055c2024-10-12WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEChain Drug Marketing Association8eab9d79-69c1-44b8-9145-a7ebd887d54d2024-10-11WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEChain Drug Marketing Associatione4963eec-fb4a-425c-be19-f514b4f10a7f2024-10-11WarningsExact identifier
application number: M012
Severe Sinus Congestion and PainACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Association1b4e87f8-3f9e-4865-9128-527d2d6215932024-10-11WarningsExact 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