FDA.reportPublic FDA data

Vicks NyQuil HIGH BLOOD PRESSURE

Product NDC
69423-973
11-digit product format
694230973
Labeler code
69423
Product ID
69423-973_5d1af7a9-11af-430e-e063-6294a90a5eed
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine succinate
Dosage form
LIQUID
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-07-12
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
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 NyQuil HIGH BLOOD PRESSURE
Brand name suffix
Cold and Flu
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/30mL
DEXTROMETHORPHAN HYDROBROMIDE30 mg/30mL
DOXYLAMINE SUCCINATE12.5 mg/30mL

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
69423-973-06VICKS ® NyQuil™ HIGH BLOOD PRESSURE COLD & FLU
69423-973-06VICKS ® NyQuil™ HIGH BLOOD PRESSURE COLD & FLU
69423-973-06VICKS ® NyQuil™ HIGH BLOOD PRESSURE COLD & FLU
69423-973-08VICKS ® NyQuil™ HIGH BLOOD PRESSURE COLD & FLU
69423-973-08VICKS ® NyQuil™ HIGH BLOOD PRESSURE COLD & FLU
69423-973-08VICKS ® NyQuil™ HIGH BLOOD PRESSURE COLD & FLU

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-973-06Vicks NyQuil HIGH BLOOD PRESSURECold and Flu177 mL in 1 BOTTLE, PLASTICLIQUID17711
69423-973-08Vicks NyQuil HIGH BLOOD PRESSURECold and Flu236 mL in 1 BOTTLE, PLASTICLIQUID23611
69423-973-06Vicks DayQuil and Vicks NyQuil HIGH BLOOD PRESSURECOLD and FLU177 mL in 1 BOTTLE, PLASTICLIQUID236 mL650 mg in 30mL9
69423-973-08Vicks DayQuil and Vicks NyQuil HIGH BLOOD PRESSURECOLD and FLU236 mL in 1 BOTTLE, PLASTICLIQUID236 mL650 mg in 30mL9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-973VICKS NYQUIL HIGH BLOOD PRESSURE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) LIQUID [THE PROCTER & GAMBLE MANUFACTURING COMPANY]9Current NDC, Legacy NDC, 2 package rows20241012_d83c4691-785d-d1a0-e053-2995a90ad196.zip
69423-973VICKS DAYQUIL AND VICKS NYQUIL HIGH BLOOD PRESSURE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY]7Current NDC, Legacy NDC20241012_efbda62c-5d1a-2026-e053-2995a90a95d7.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 166 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens AllergyDIPHENHYDRAMINE HCLQUALITY CHOICE (Chain Drug Marketing Association)c573da1e-c7ca-46e6-ad42-4ded2547afc32024-04-22WarningsExact identifier
application number: M012
Cough Relief Cough SuppressantDEXTROMETHORPHAN HBRQUALITY CHOICE (Chain Drug Marketing Association)13ae4c67-a3fe-440c-91b8-c9412626c3cd2024-04-22WarningsExact identifier
application number: M012
Pain Relief PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLQUALITY CHOICE (Chain Drug Marketing Association)47660794-22cc-4863-a183-e694d27e35432024-04-19WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)f9c08b18-a119-406b-bd96-73572b4445e22024-04-18WarningsExact identifier
application number: M012
Nighttime Cough ReliefDEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)e1fa0f51-6a68-4f6f-8988-0949d1942c2f2024-04-18WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)025f6622-a6db-4a5c-aebd-5d54172fa4a12024-04-18WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)f9530d55-8226-4659-84f0-2c0b411572be2024-04-17WarningsExact identifier
application number: M012
MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIMEACETAMINOPHEN 325 MG DEXTROMETHORPHAN HBR 10 MG PHENYLEPHRINE HCI 5 MGRITE AIDc92dbbbb-d149-1e7e-e053-2a95a90a6f1a2024-04-17WarningsExact identifier
application number: M012
MULTI-SYMPTOM COLD AND FLU RELIEF NIGHTTIMEACETAMINOPHEN 325 MG DEXTROMETHORPHAN HBR 15 MG DOXYLAMINE SUCCINATE 6.25 MGRITE AIDc9323799-3505-d6c1-e053-2995a90a6f432024-04-17WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)fac8b01a-9666-43cc-a4ff-3f3ed452c7e42024-04-17WarningsExact identifier
application number: M012
Daytime Nighttime Cold and Flu Relief Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLP & L Development, LLC15e9a336-1b34-4f00-9d1c-b945ddf17ed92024-04-16WarningsExact identifier
application number: M012
Dimetapp Cough and AllergyDIPHENHYDRAMINE HYDROCHLORIDEFoundation Consumer Healthcare15b0f5ff-202a-d19f-e063-6394a90af2b82024-04-15WarningsExact identifier
application number: M012
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLP & L Development, LLC8d27b94d-23a1-4e6c-a064-79e2580f7e2e2024-04-15WarningsExact identifier
application number: M012
Severe Cold and Cough Relief DaytimeACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLP & L Development, LLC2af496a1-6fdd-4acf-9944-8b7cdf3022752024-04-15WarningsExact identifier
application number: M012
Childrens Dye Free AllergyDIPHENHYDRAMINE HYDROCHLORIDEP & L Development, LLC1c4d09ed-4e0f-430d-b17f-6a23f996a55d2024-04-15WarningsExact identifier
application number: M012
Theraflu ExpressMax Daytime Nighttime Value PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLHaleon US Holdings LLC9736ad4c-8c2e-421f-b023-f91b72d2828b2024-04-10WarningsExact identifier
application number: M012
Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCLHaleon US Holdings LLCb06b64c5-dbb4-4ef5-af18-3d7d4979c02f2024-04-10WarningsExact identifier
application number: M012
Daytime Nighttime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCI DOXYLAMINESUCINATEHarris Teeter, LLCec603195-eb36-4b5c-bc9b-c2074205b2b22024-04-09WarningsExact identifier
application number: M012
Daytime Cold and Flu Non drowsyACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEHarris Teeter, LLC9b0648ac-0ce3-4eaa-8977-26ae864f034d2024-04-09WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCLHaleon US Holdings LLCf147d82e-4429-4c7b-bd2b-e21a09f21c922024-04-09WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral SolutionPSNd83c4691-785d-d1a0-e053-2995a90ad19611
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCDd83c4691-785d-d1a0-e053-2995a90ad19611
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSYd83c4691-785d-d1a0-e053-2995a90ad19611
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSYd83c4691-785d-d1a0-e053-2995a90ad19611
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSYd83c4691-785d-d1a0-e053-2995a90ad19611
2637726{1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution) } PackGPCKefbda62c-5d1a-2026-e053-2995a90a95d79
26377261 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution) PackPSNefbda62c-5d1a-2026-e053-2995a90a95d79
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSNefbda62c-5d1a-2026-e053-2995a90a95d79
2604561acetaminophen 650 MG / dextromethorphan HBr 20 MG in 30 mL Oral SolutionPSNefbda62c-5d1a-2026-e053-2995a90a95d79
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral SolutionPSNefbda62c-5d1a-2026-e053-2995a90a95d79
1113705acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCDefbda62c-5d1a-2026-e053-2995a90a95d79
2604561acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML Oral SolutionSCDefbda62c-5d1a-2026-e053-2995a90a95d79
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCDefbda62c-5d1a-2026-e053-2995a90a95d79
26377261 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 mL Oral Solution) PackSYefbda62c-5d1a-2026-e053-2995a90a95d79
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSYefbda62c-5d1a-2026-e053-2995a90a95d79
2604561acetaminophen 325 MG / dextromethorphan HBr 10 MG per 15 ML Oral SolutionSYefbda62c-5d1a-2026-e053-2995a90a95d79
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSYefbda62c-5d1a-2026-e053-2995a90a95d79
1113705acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSYefbda62c-5d1a-2026-e053-2995a90a95d79
2604561acetaminophen 650 MG / dextromethorphan HBr 20 MG per 30 ML Oral SolutionSYefbda62c-5d1a-2026-e053-2995a90a95d79
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSYefbda62c-5d1a-2026-e053-2995a90a95d79
1113705APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSYefbda62c-5d1a-2026-e053-2995a90a95d79
2604561APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML Oral SolutionSYefbda62c-5d1a-2026-e053-2995a90a95d79
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSYefbda62c-5d1a-2026-e053-2995a90a95d79

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69423-973-0669423097306177 mL in 1 BOTTLE, PLASTIC (69423-973-06) 177 ml2022-07-120000-00-00NoNoCurrent
69423-973-0869423097308236 mL in 1 BOTTLE, PLASTIC (69423-973-08) 236 ml2022-07-120000-00-00NoNoCurrent