FDA.reportPublic FDA data

Vicks DayQuil VapoCOOL SEVERE

Product NDC
69423-987
11-digit product format
694230987
Labeler code
69423
Product ID
69423-987_5afafeef-6087-c433-e063-6394a90a469a
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-08-01
Marketing end
2027-05-06
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [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 DayQuil VapoCOOL SEVERE
Brand name suffix
COLD and FLU plus CONGESTION

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1
GUAIFENESIN200 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
9D2RTI9KYHInternal UNII lookup
495W7451VQInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
efb69cc1-a745-6efc-e053-2a95a90abdc9Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-987-24Vicks DayQuil VapoCOOL SEVERECOLD and FLU plus CONGESTION1 in 1 CARTONTABLET19
69423-987-24Vicks DayQuil VapoCOOL SEVERECOLD and FLU plus CONGESTION24 in 1 BLISTER PACKTABLET249

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-987VICKS DAYQUIL VAPOCOOL SEVERE COLD AND FLU PLUS CONGESTION (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [THE PROCTER & GAMBLE MANUFACTURING COMPANY]8Current NDC, Legacy NDC, 2 package rows20241012_efb69cc1-a745-6efc-e053-2a95a90abdc9.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 147 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
sinus pressure and pain peACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEGOODSENSEa7931e4c-8a5e-66e2-e053-2995a90af2a42024-10-18WarningsExact identifier
application number: M012
Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGoodSense570ea130-6a99-446e-9f97-14fc958090062024-10-18WarningsExact identifier
application number: M012
Sinus and HeadacheACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEGOODSENSEa14999e3-a9d9-0a1f-e053-2995a90af7b32024-10-18WarningsExact identifier
application number: M012
Allergy Multi SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDEGOODSENSEa793000b-3ef9-5662-e053-2a95a90ad0da2024-10-18WarningsExact identifier
application number: M012
Cold Multi-Symptom Daytime and NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEGoodSense37455f86-ab21-472b-9e80-40324699f3ca2024-10-18WarningsExact identifier
application number: M012
Head Congestion Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGOODSENSEe3396a27-8643-71fa-e053-2a95a90a713d2024-10-18WarningsExact identifier
application number: M012
Head Congestion Flu Severe PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGOODSENSEe3397f69-3267-ca0b-e053-2995a90a7db52024-10-18WarningsExact identifier
application number: M012
Cold and Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGoodSense747512a2-3b6d-496b-ab80-8190603141632024-10-18WarningsExact identifier
application number: M012
Allergy Multi SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDEAMERISOURCE BERGEN9daf7f40-d9c5-4367-be41-894208358fc12024-10-18WarningsExact identifier
application number: M012
Cold MaxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEAmeriSource Bergen608e6808-29e4-40bc-8496-24c092681a1b2024-10-18WarningsExact identifier
application number: M012
Cold Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEAmeriSource Bergen665db127-ee04-46c4-bff0-e0fe9950c3e22024-10-18WarningsExact identifier
application number: M012
Cold Max Day and NightACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEAmeriSource Bergen87a1cc06-9994-4fa9-8c64-e2ffdd33a2f82024-10-18WarningsExact identifier
application number: M012
Cold Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEAmeriSource Bergen604d7e53-4bfd-4cdd-aed2-b304ae82ce442024-10-18WarningsExact identifier
application number: M012
AllergyDIPHENHYDRAMINE HYDROCHLORIDEDISCOUNT DRUG MART4d93a703-c905-4fb3-b772-11c207065d4d2024-10-17WarningsExact identifier
application number: M012
Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MART62c35320-87b5-46e2-9f6f-cb0882bdb52e2024-10-17WarningsExact identifier
application number: M012
Cold Max NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTe3dcf6cf-373c-ea83-e053-2a95a90ae57a2024-10-17WarningsExact identifier
application number: M012
Sinus Pressure plus Pain PEACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTa7e99dad-5918-6a90-e053-2a95a90a88032024-10-17WarningsExact identifier
application number: M012
SINUS AND HEADACHEACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTa7e99dad-5916-6a90-e053-2a95a90a88032024-10-17WarningsExact identifier
application number: M012
ALLERGY MULTISYMPTOMACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTa7e9ab8e-2252-180d-e053-2a95a90a788f2024-10-17WarningsExact identifier
application number: M012
COLD PLUS HEAD CONGESTION SEVEREACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MART3430c7e4-e142-407e-bed5-358dd6bd10f72024-10-17WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1110988acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSNefb69cc1-a745-6efc-e053-2a95a90abdc99
1110988acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDefb69cc1-a745-6efc-e053-2a95a90abdc99
1110988APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSYefb69cc1-a745-6efc-e053-2a95a90abdc99
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
69423-987-02694230987022 TABLET in 1 POUCH (69423-987-02) 2 tablet2018-08-010000-00-00NoNoCurrent
69423-987-24694230987241 BLISTER PACK in 1 CARTON (69423-987-24) / 24 TABLET in 1 BLISTER PACK1 blister pack2021-03-222027-05-06NoNoCurrent