FDA.reportPublic FDA data

Vicks DayQuil and Nyquil VapoCOOL Severe

Product NDC
69423-988
11-digit product format
694230988
Labeler code
69423
Product ID
69423-988_5afb1373-0d87-d32f-e063-6394a90afff0
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Phenylephrine Hydrochloride, and Doxylamine Succinate
Dosage form
KIT
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-22
Marketing end
2027-05-06
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 DayQuil and Nyquil VapoCOOL Severe
Brand name suffix
COLD and FLU plus CONGESTION

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1110988Internal RxNorm lookup
1546881Internal RxNorm lookup
2634817Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f4328b44-cdfa-41aa-e053-2995a90a2728Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
69423-988-24Vicks ® DayQuil™ & Nyquil™ VapoCOOL SEVERE COLD & FLU + CONGESTION, Coated Caplets
69423-988-24Vicks ® DayQuil™ & Nyquil™ VapoCOOL SEVERE COLD & FLU + CONGESTION, Coated Caplets
69423-988-48Vicks ® DayQuil™ & Nyquil™ VapoCOOL SEVERE COLD & FLU + CONGESTION, Coated Caplets
69423-988-48Vicks ® DayQuil™ & Nyquil™ VapoCOOL SEVERE COLD & FLU + CONGESTION, Coated Caplets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-988-24Vicks DayQuil and Nyquil VapoCOOL SevereCOLD and FLU plus CONGESTION1 in 1 PACKAGEKIT16
69423-988-48Vicks DayQuil and Nyquil VapoCOOL SevereCOLD and FLU plus CONGESTION1 in 1 PACKAGEKIT16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-988VICKS DAYQUIL AND NYQUIL VAPOCOOL SEVERE COLD AND FLU PLUS CONGESTION (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY]5Current NDC, 2 package rows20241012_f4328b44-cdfa-41aa-e053-2995a90a2728.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 155 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topcare NasalOXYMETAZOLINE HYDROCHLORIDETopco Associates LLCf1dd78e0-f700-4469-85d6-18cc299e87462024-08-28WarningsExact identifier
application number: M012
equaline nasalOXYMETAZOLINE HCLUnited Natural Foods, Inc. dba UNFI69308693-a094-42a9-a041-e73647a25cc12024-08-27WarningsExact identifier
application number: M012
signature care nasal decongestantOXYMETAZOLINE HYDROCHLORIDESafewayf9ac80d1-3753-412b-a407-18a6b50e5d1c2024-08-27WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.20ac6010-84f4-eeff-e063-6294a90a50a72024-08-27WarningsExact identifier
application number: M012
Exchange Select NasalOXYMETAZOLINE HCLArmy & Air Force Exchange Service40d2090d-c332-4dcb-9f43-5ee467e7b3d12024-08-27WarningsExact identifier
application number: M012
Signature Care Nasal DecongestantOXYMETAZOLINE HCLSafeway23f0a5b3-59ae-4eb3-9b7d-e6a4920603372024-08-27WarningsExact identifier
application number: M012
DG Health NasalOXYMETAZOLINE HYDROCHLORIDEDolgencorp, LLCdebcda99-c605-4941-b873-9e4dbae274832024-08-27WarningsExact identifier
application number: M012
Good Neighbor Pharmacy NasalOXYMETAZOLINE HCLAmerisource Bergend374d697-2b57-4558-a20b-d3d89aea82d72024-08-27WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HCLMeijer Distribution Inc3984cbc3-b60c-40a7-bc3a-7d1f600503ac2024-08-27WarningsExact identifier
application number: M012
foster and thrive nasalOXYMETAZOLINE HYDROCHLORIDEStrategic Sourcing Services LLCe6e51821-03ae-4ec3-82a9-b4a8feacd9962024-08-27WarningsExact identifier
application number: M012
Pyrilamine Maleate and Dextromethorphan HydrobromidePYRILAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDEWestminster Pharmaceuticals, LLCdd068449-9d24-41e6-8a6e-f69c9fe263f22024-08-26WarningsExact identifier
application number: M012
basic care nasalOXYMETAZOLINE HYDROCHLORIDEAmazon.com Services LLCa154e500-2b45-4242-a26c-9530849f99df2024-08-23WarningsExact identifier
application number: M012
Daytime Nighttime Ultra Concentrated Cold and FluDAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCL AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATETARGET CORPORATION0c0cf76f-2dd3-45ef-e063-6394a90a9fef2024-08-22WarningsExact identifier
application number: M012
Day Cold and Flu and Night Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCLTARGET CORPORATION08ee56d1-b11d-3e36-e063-6294a90acd5f2024-08-22WarningsExact identifier
application number: M012
Maximum Strength Daytime Cold and Flu and Nighttime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE,TRIPROLIDINE HYDROCHLORIDETARGET CORPORATION0fc523ce-55a7-6384-e063-6394a90aad3f2024-08-22WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWalgreens8045aef9-22bc-4146-b494-dbb1ffef06df2024-08-19WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.5a2053d4-9c0d-4613-9cf5-0067173f37302024-08-16WarningsExact identifier
application number: M012
QUALITY CHOICE Long Acting Cough SoftgelDEXTROMETHORPHAN HYDROBROMIDEChain Drug Marketing Association, Inc.f1ea7dfc-c605-45a1-ad1d-6e636a8a7b1c2024-08-16WarningsExact identifier
application number: M012
pseudoephedrine hydrochloridePSEUDOEPHEDRINE HCLPadagis Israel Pharmaceuticals Ltd458594e1-8d99-4de3-8923-2fd8ce2fc4062024-08-16WarningsExact identifier
application number: M012
Halls Sugar Free Mountain MentholMENTHOLMondelez Global LLC54e0d57e-1f48-45e2-86b3-0e50775996f42024-08-15WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2634817{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Tablet) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet) } PackGPCKf4328b44-cdfa-41aa-e053-2995a90a27286
26348171 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Tablet) PackPSNf4328b44-cdfa-41aa-e053-2995a90a27286
1546881acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral TabletPSNf4328b44-cdfa-41aa-e053-2995a90a27286
1110988acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSNf4328b44-cdfa-41aa-e053-2995a90a27286
1546881acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDf4328b44-cdfa-41aa-e053-2995a90a27286
1110988acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDf4328b44-cdfa-41aa-e053-2995a90a27286
26348171 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Tablet) PackSYf4328b44-cdfa-41aa-e053-2995a90a27286
1546881APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSYf4328b44-cdfa-41aa-e053-2995a90a27286
1110988APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSYf4328b44-cdfa-41aa-e053-2995a90a27286

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69423-988-24694230988241 KIT in 1 PACKAGE (69423-988-24) * 1 TABLET in 1 BLISTER PACK * 1 TABLET, COATED in 1 BLISTER PACK1 kit2021-03-222027-05-06NoNoHistorical
69423-988-48694230988481 KIT in 1 PACKAGE (69423-988-48) * 1 TABLET in 1 BLISTER PACK * 1 TABLET, COATED in 1 BLISTER PACK1 kit2021-03-222027-05-06NoNoHistorical