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 121 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UP AND UP NO DRIP NASALOXYMETAZOLINE HYDROCHLORIDETarget Corporation760d6d0f-00fc-40bc-858d-83a0827d139f2025-01-29WarningsExact identifier
application number: M012
Guaifenesin and DextromethorphanGUAIFENESIN AND DEXTROMETHORPHANMajor Pharmaceuticals51e48201-bb62-4e89-85eb-e4a416f935222025-01-29WarningsExact identifier
application number: M012
Severe Congestion and Cough MaxDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLBest Choice8c878e47-94f4-484f-bdd8-6d87ac2440d82025-01-28WarningsExact identifier
application number: M012
Cough and Cold TherapyCAMPHOR, MENTHOL, EUCALYPTUS OILEverlaan Organics Inc088be461-7afc-586a-e063-6294a90a700b2025-01-27WarningsExact identifier
application number: M012
Cough and Cold Therapy For KidsCAMPHOR, MENTHOL, EUCALYPTUS OILEverlaan Organics Inc088df369-114c-db4f-e063-6394a90acfac2025-01-27WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOLTarget Corporation Inc.eb4c2c3f-91d7-e4c6-e053-2a95a90a4e8a2025-01-26WarningsExact identifier
application number: M012
Walgreens Menthol Cough DropsMENTHOLWalgreens2c62f690-8dfb-d28e-e063-6394a90a45a22025-01-23WarningsExact identifier
application number: M012
Walgreens Cherry Cough DropsMENTHOLWalgreens2c65d836-e724-50d6-e063-6394a90a08272025-01-23WarningsExact identifier
application number: M012
Walgreens Honey Lemon Cough DropsMENTHOLWalgreens2c67424c-2fb0-cc15-e063-6394a90a02ca2025-01-23WarningsExact identifier
application number: M012
Pharmacys Prescription Analgesic GelMENTHOLAmerican Consumer Products Corp6f0725f2-833f-f3a0-e053-2a91aa0a39112025-01-23WarningsExact identifier
application number: M012
Pharmacys Prescription Vapor RubMENTHOLAmerican Consumer Products Corp6ef328ff-f5c3-515d-e053-2a91aa0a32d32025-01-23WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLBest Choice0035e6a4-b3ef-4e0b-aa7f-7453dd065f4d2025-01-22WarningsExact identifier
application number: M012
GOOD REMEDIES Allergy Relief SOFTGELDIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.26a02737-2cfd-769f-e063-6394a90af3522025-01-22WarningsExact identifier
application number: M012
PharbechlorCHLORPHENIRAMINE MALEATE 4MGUlai Health LLC6a1a5cef-e946-4ba8-9402-557c6adf45f92025-01-20WarningsExact identifier
application number: M012
PharbinexGUAIFENESIN 400MGUlai Health LLC4eafa81a-aeee-4c97-85d6-594902b109192025-01-20Exact identifier
application number: M012
Pharbinex-PEGUAIFENESIN 400MG AND PHENYLEPHRINE HCL 10MGUlai Health LLCe459bb83-b1d6-42fc-aa46-99ad117e61442025-01-20Exact identifier
application number: M012
Pharbinex-DMGUAIFENESIN 400MG AND DEXTROMETHORPHAN HBR 20MGUlai Health LLCaf80d10e-3fb2-405a-a803-1f876b8dcd102025-01-20Exact identifier
application number: M012
Alka-Seltzer Plus Multi-Symptom Cold and Flu Day and Night Liquid GelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLBayer HealthCare LLC.34b2e77f-5d04-15a7-e054-00144ff8d46c2025-01-17WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Orange ZestASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.a23a6db6-4585-2882-e053-2a95a90ab01a2025-01-17WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold Night PowerFast FizzASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.fc754dff-cecd-fc6b-e053-6394a90ab3712025-01-17WarningsExact 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