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 137 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHYLEPHRINE BITARTRATETopco Associates LLCa2929bcb-fa81-4f15-b087-a9996b5e7d1f2024-11-13WarningsExact identifier
application number: M012
Equate Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEWalmart6271bb48-74b2-eb57-e053-2991aa0afd1b2024-11-13WarningsExact identifier
application number: M012
Equaline Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEUnited Natural Foods, Inc. dba UNFI6bf341e0-94b1-08ff-e053-2991aa0af6342024-11-13WarningsExact identifier
application number: M012
Good Sense Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEGood Sensecd25e250-bb8b-7e83-e053-2a95a90a26392024-11-13WarningsExact identifier
application number: M012
Top Value Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATETower Laboratories Ltd440a00b1-7960-0cc4-e054-00144ff8d46c2024-11-13WarningsExact identifier
application number: M012
Top Value Effervescent Cold Relief - OrangeASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATETower Laboratories Ltd.c6f207e8-bc0d-853a-e053-2a95a90ac6232024-11-13WarningsExact identifier
application number: M012
Effervescent Orange Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEDOLGENCORP, LLC7fad8e65-34fe-5313-e053-2a91aa0a56f42024-11-13WarningsExact identifier
application number: M012
Dollar General Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHYLEPHRINE BITARTRATEDOLGENCORP, LLC7face5c7-f5c7-7eee-e053-2991aa0ab0642024-11-13WarningsExact identifier
application number: M012
Quality Choice Effervescent Cold Relief PlusASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATEChain Drug Marketing Association90622927-9682-4eb0-8c7f-894230b3dda42024-11-13WarningsExact identifier
application number: M012
Quality Choice Effervescent Cold Relief - OrangeASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEChain Drug Marketing Association9f7d76f0-4f1c-a1c7-e053-2a95a90a3dca2024-11-13WarningsExact identifier
application number: M012
WinCo Foods Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATEWinCo Foods, LLCd443a030-d3d6-40e0-8fe0-329de6bc494f2024-11-13WarningsExact identifier
application number: M012
careone tussin dmDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmerican Sales Company954fe703-9a10-4354-8b71-4d98a22a0b9f2024-11-13WarningsExact identifier
application number: M012
NASAL DECONGESTANT PEPHENYLEPHRINE HCLA-S Medication Solutions9d030767-dfd6-48b4-9b17-4e20c23915f32024-11-13WarningsExact identifier
application number: M012
Childrens SUDAFED PE Cold plus CoughDEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC20e45243-3989-413a-bcf1-49d754ff2e442024-11-12WarningsExact identifier
application number: M012
Tukol Cough And Cold Honey FlavorDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USAa4b333dc-58da-45db-87b6-6fcb8fb542b82024-11-12WarningsExact identifier
application number: M012
daytime nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreen Company4b49137c-8fc9-43b7-b1a1-82e318237eb62024-11-12WarningsExact identifier
application number: M012
CVS Original Nasal MistOXYMETAZOLINE HCLCVS PHARMACY, INCe9c551a0-cd78-4272-b42f-36c096d267362024-11-12WarningsExact identifier
application number: M012
up and up cough plus chest congestionDEXTROMETHORPHAN HBR, GUAIFENESINTarget Corporationed5dfeb1-8f7a-46ff-ae27-3fa5de5b397c2024-11-12WarningsExact identifier
application number: M012
DG Health Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEDolgencorp Incb33d104b-0b4d-40c6-8345-c2c7403273312024-11-11WarningsExact identifier
application number: M012
Zephrex DPSEUDOEPHEDRINE HYDROCHLORIDEL. Perrigo Company5468a7e2-361b-494f-9ca3-1b62f3819f652024-11-11WarningsExact 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