Vicks NyQuil

Product NDC
37000-815
11-digit product format
370000815
Labeler code
37000
Product ID
37000-815_4b32e0b1-2acf-311a-e063-6394a90a2aa5
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-07-21
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Vicks NyQuil
Brand name suffix
Severe Cold and Flu
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/30mL
DEXTROMETHORPHAN HYDROBROMIDE20 mg/30mL
DOXYLAMINE SUCCINATE12.5 mg/30mL
PHENYLEPHRINE HYDROCHLORIDE10 mg/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2, 04JA59TNSJ
Rxcui1431245

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37000-815-082024-01-30C16284748780-1ba0f9c33-514d-a910-e053-dadaa90a0b85Vicks ® NyQuil™ Severe Cold & Flu Original Liquid
37000-815-122024-01-30C16284748780-1ba0f9c33-514d-a910-e053-dadaa90a0b85Vicks ® NyQuil™ Severe Cold & Flu Original Liquid
37000-815-362024-01-30C16284748780-1ba0f9c33-514d-a910-e053-dadaa90a0b85Vicks ® NyQuil™ Severe Cold & Flu Original Liquid
37000-815-082022-10-11C16284748780-1ba0f9c33-514d-a910-e053-dadaa90a0b85Vicks ® NyQuil™ Severe Cold & Flu Original Liquid
37000-815-122022-10-11C16284748780-1ba0f9c33-514d-a910-e053-dadaa90a0b85Vicks ® NyQuil™ Severe Cold & Flu Original Liquid
37000-815-242022-10-11C16284748780-1ba0f9c33-514d-a910-e053-dadaa90a0b85Vicks ® NyQuil™ Severe Cold & Flu Original Liquid
37000-815-362022-10-11C16284748780-1ba0f9c33-514d-a910-e053-dadaa90a0b85Vicks ® NyQuil™ Severe Cold & Flu Original Liquid
37000-815-082022-07-29C16284748780-1ba0f9c33-514d-a910-e053-dadaa90a0b85Vicks ® NyQuil™ Severe Cold & Flu Original Liquid
37000-815-122022-07-29C16284748780-1ba0f9c33-514d-a910-e053-dadaa90a0b85Vicks ® NyQuil™ Severe Cold & Flu Original Liquid
37000-815-242022-07-29C16284748780-1ba0f9c33-514d-a910-e053-dadaa90a0b85Vicks ® NyQuil™ Severe Cold & Flu Original Liquid
37000-815-362022-07-29C16284748780-1ba0f9c33-514d-a910-e053-dadaa90a0b85Vicks ® NyQuil™ Severe Cold & Flu Original Liquid
37000-815-082021-02-11C16284748780-1ba0f9c33-514d-a910-e053-dadaa90a0b85Vicks ® NyQuil™ Severe Cold & Flu Original Liquid
37000-815-122021-02-11C16284748780-1ba0f9c33-514d-a910-e053-dadaa90a0b85Vicks ® NyQuil™ Severe Cold & Flu Original Liquid
37000-815-242021-02-11C16284748780-1ba0f9c33-514d-a910-e053-dadaa90a0b85Vicks ® NyQuil™ Severe Cold & Flu Original Liquid
37000-815-362021-02-11C16284748780-1ba0f9c33-514d-a910-e053-dadaa90a0b85Vicks ® NyQuil™ Severe Cold & Flu Original Liquid
37000-815-082021-01-29C16284748780-1ba0f9c33-514d-a910-e053-dadaa90a0b85Vicks ® NyQuil™ Severe Cold & Flu Original Liquid
37000-815-122021-01-29C16284748780-1ba0f9c33-514d-a910-e053-dadaa90a0b85Vicks ® NyQuil™ Severe Cold & Flu Original Liquid
37000-815-242021-01-29C16284748780-1ba0f9c33-514d-a910-e053-dadaa90a0b85Vicks ® NyQuil™ Severe Cold & Flu Original Liquid
37000-815-362021-01-29C16284748780-1ba0f9c33-514d-a910-e053-dadaa90a0b85Vicks ® NyQuil™ Severe Cold & Flu Original Liquid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-815-08Vicks NyQuilSevere Cold and Flu236 mL in 1 BOTTLE, PLASTICSOLUTION23617
37000-815-12Vicks NyQuilSevere Cold and Flu354 mL in 1 BOTTLE, PLASTICSOLUTION35417
37000-815-36Vicks NyQuilSevere Cold and Flu3 in 1 PACKAGE, COMBINATIONSOLUTION317
37000-815-12Vicks DayQuil and Vicks NyQuilSevere Cold and Flu354 mL in 1 BOTTLE, PLASTICSOLUTION354 mL650 mg in 30mL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-815VICKS NYQUIL SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [THE PROCTER & GAMBLE MANUFACTURING COMPANY]15Current NDC, Legacy NDC, 3 package rows20241012_390d0187-a6f4-4387-a528-9eb70e250db1.zip
37000-815VICKS DAYQUIL AND VICKS NYQUIL SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY]9Current NDC, Legacy NDC20241012_4147ff00-8e21-7335-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1431245acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral SolutionPSN390d0187-a6f4-4387-a528-9eb70e250db117
1431245acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCD390d0187-a6f4-4387-a528-9eb70e250db117
1431245acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSY390d0187-a6f4-4387-a528-9eb70e250db117
1431245acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSY390d0187-a6f4-4387-a528-9eb70e250db117
1431245APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral SolutionSY390d0187-a6f4-4387-a528-9eb70e250db117
2637731{1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) } PackGPCK4147ff00-8e21-7335-e054-00144ff88e8812
26377311 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution) PackPSN4147ff00-8e21-7335-e054-00144ff88e8812
1369842acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSN4147ff00-8e21-7335-e054-00144ff88e8812
1431245acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral SolutionPSN4147ff00-8e21-7335-e054-00144ff88e8812
1431245acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCD4147ff00-8e21-7335-e054-00144ff88e8812
1369842acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCD4147ff00-8e21-7335-e054-00144ff88e8812
26377311 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG per 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 mL Oral Solution) PackSY4147ff00-8e21-7335-e054-00144ff88e8812
1431245acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSY4147ff00-8e21-7335-e054-00144ff88e8812
1369842acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSY4147ff00-8e21-7335-e054-00144ff88e8812
1431245acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSY4147ff00-8e21-7335-e054-00144ff88e8812
1369842acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSY4147ff00-8e21-7335-e054-00144ff88e8812
1431245APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral SolutionSY4147ff00-8e21-7335-e054-00144ff88e8812
1369842APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / Guaifenesin 13.3 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral SolutionSY4147ff00-8e21-7335-e054-00144ff88e8812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-815-0837000081508236 mL in 1 BOTTLE, PLASTIC (37000-815-08) 236 ml2014-07-210000-00-00NoNoCurrent
37000-815-1237000081512354 mL in 1 BOTTLE, PLASTIC (37000-815-12) 354 ml2014-07-210000-00-00NoNoCurrent
37000-815-24370000815242 BOTTLE, PLASTIC in 1 PACKAGE, COMBINATION (37000-815-24) > 354 mL in 1 BOTTLE, PLASTIC (37000-815-12) 2014-07-210000-00-00NoNoCurrent
37000-815-36370000815363 BOTTLE, PLASTIC in 1 PACKAGE, COMBINATION (37000-815-36) / 354 mL in 1 BOTTLE, PLASTIC (37000-815-12) 2014-07-210000-00-00NoNoCurrent