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
69423-973-08VICKS ® 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 142 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
good neighbor pharmacy adult tussin DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAmerisource Bergenced71993-f535-4e28-bc1d-3fcb7d86e9b72024-11-08WarningsExact identifier
application number: M012
adult tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS Pharmacy2f1dc8f8-79c5-4724-99aa-a55330ed9d5f2024-11-08WarningsExact identifier
application number: M012
good sense day time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEL. Perrigo Company4ac6b64a-8214-4b03-8aa5-0d3199cf0b722024-11-08WarningsExact identifier
application number: M012
tussinDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINH E B1dd9afb6-9b58-4274-a557-900a0cb235242024-11-08WarningsExact identifier
application number: M012
DG health sinus severeOXYMETAZOLINE HYDROCHLORIDEDolgencorp, LLC7abaa912-be8b-463c-8818-104e79b335392024-11-07WarningsExact identifier
application number: M012
Extra Strength TYLENOL Cold Plus Flu Multi-Action DayACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC7d3266dc-879a-4d28-b8ea-74d238c3020a2024-11-07WarningsExact identifier
application number: M012
TYLENOL COLD PLUS FLU SEVERE DAY/NIGHTACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC2ddb86a8-e34c-4a03-a60a-d3fedaf906082024-11-07WarningsExact identifier
application number: M012
Tylenol Cold Plus Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCce43e5c2-fe96-4462-882c-d7479318b33d2024-11-07WarningsExact identifier
application number: M012
TYLENOL SINUS PLUS HEADACHE DAYACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCe608d214-cc46-4a24-ac85-1040e36e74032024-11-07WarningsExact identifier
application number: M012
Childrens TYLENOL COLD PLUS COUGH PLUS SORE THROATACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLCe83f7911-22b4-4ffc-8f49-68f6acd2ebf52024-11-07WarningsExact identifier
application number: M012
Extra Strength TYLENOL Severe Cough Plus Sore Throat NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE.Kenvue Brands LLCf81d924e-10e9-0e9d-e053-6294a90a2ddf2024-11-07WarningsExact identifier
application number: M012
Childrens TYLENOL COLD Plus FLUACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC8b516736-86ac-47cb-a0ec-038d4c3a00202024-11-07WarningsExact identifier
application number: M012
Tylenol Cold plus Flu plus Cough NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCe85e5eb9-3ecf-4784-999e-111e38e306f52024-11-07WarningsExact identifier
application number: M012
TYLENOL COLD PLUS FLU SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCef8a846d-4b29-4fd8-a683-fada04d0a2b92024-11-07WarningsExact identifier
application number: M012
Childrens TYLENOL COLD Plus FLUACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC9761c807-75a1-4498-a8c6-1f2b1c9ffde62024-11-07WarningsExact identifier
application number: M012
TYLENOL Cold Plus Mucus SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC24ac94e8-b223-424e-bcd2-9c027c8ff9ed2024-11-07WarningsExact identifier
application number: M012
PrimateneEPHEDRINE HYDROCHLORIDEFoundation Consumer Brands2170f081-c03f-47e8-bc63-4052c5e653fa2024-11-07WarningsExact identifier
application number: M012
Rompe Pecho Max Multi SymptomsACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESINEFFICIENT LABORATORIES INC938e4e47-d2d9-4b0d-bf88-e9f41b5019452024-11-07WarningsExact identifier
application number: M012
topcare sinus nasalOXYMETAZOLINE HYDROCHLORIDETopco Associates LLCca1fefed-e9d7-430a-9da4-972b1a6fb7862024-11-07WarningsExact identifier
application number: M012
Leader Daytime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECardinal Health 110, LLC. dba Leaderdd82a389-9ec5-4b3f-a9ea-1a56871ebd172024-11-07WarningsExact 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