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 78 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vaporizing RubCAMPHOR, EUCALYPTUS OIL AND MENTHOLALAINA HEALTHCARE PRIVATE LIMITED4c6a7ac0-be76-42b0-9a08-b287e70a34602025-12-09WarningsExact identifier
application number: M012
24-7 Life BY 7-ELEVEN Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE SOLUTIONLil' Drug Store products, Inc.277363f4-1c00-ddb7-e063-6294a90a46772025-12-09WarningsExact identifier
application number: M012
Daytime Cold and Flu Relief, 24-7 Life BY 7-ElevenACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL SOLUTIONLil' Drug Store Products, Inc.2771d699-3f70-4318-e063-6394a90a89cc2025-12-09WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEShield Pharmaceuticals Corp3d243264-5cd8-47da-9f5e-cfcfc8d1fa4b2025-12-09WarningsExact identifier
application number: M012
Circle K Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATELil' Drug Store Products, Inc9a32bc6d-0499-48fa-a6ad-702c8a28bf5f2025-12-09WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEShield Pharmaceuticals Corp5015a380-a229-4eff-8e31-528065c6ed642025-12-09WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHarris Teetercaf59320-5b48-4533-bda9-7b03a2fde0b52025-12-09WarningsExact identifier
application number: M012
Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLC30d41dc3-e2ef-4cad-b63c-d634bc749aa12025-12-09WarningsExact identifier
application number: M012
Walgreens Childrens Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLWalgreen Company327a7226-84b9-26d7-e063-6394a90a99b92025-12-09WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HBR AND GUAIFENESINMeijer Distribution Inc8ed5b802-a26e-45b4-a696-bc64dbac47332025-12-09WarningsExact identifier
application number: M012
dg health cold plus flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDolgencorp, LLCff4a2f0a-d638-4ed2-8e05-2a52afbc49092025-12-09WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCLQUALITY CHOICE (Chain Drug Marketing Association)24894484-b834-4b2f-b365-c95b5e30d8bf2025-12-09WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEFamily Dollar (FAMILY WELLNESS)2c431220-c61b-4ad5-9ad2-58ccaee2d1c32025-12-09WarningsExact identifier
application number: M012
Sinus PE Congestion Daytime NighttimeDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLMeijer Distribution, Inc.9da77306-5098-4c79-845c-97ead849c84a2025-12-08WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)fdd0dadc-5313-4f6e-aef5-ca853efe5c4d2025-12-08WarningsExact identifier
application number: M012
MucolyteGUAIFENESINRising Pharma Holdings, Inc.e4091aaf-44e3-4701-9986-aff248a2f1b82025-12-08WarningsExact identifier
application number: M012
Mucolyte DMGUAIFENESIN, DEXTROMETHORPHAN HBRRising Pharma Holdings, Inc.c913d27d-bc00-4ace-9a5f-c55522e1cd1d2025-12-08WarningsExact identifier
application number: M012
honey lemon cough dropsMENTHOLAmerican Sales47f504d5-3ec5-5227-e054-00144ff88e882025-12-07WarningsExact identifier
application number: M012
Sugar Free Menthol Cough DropsMENTHOLAmerican Sales4893ac0a-7769-5657-e054-00144ff8d46c2025-12-07WarningsExact identifier
application number: M012
Cherry cough dropMENTHOLAmerican Sales45e891ea-2f2a-31b7-e054-00144ff88e882025-12-07WarningsExact 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