FDA.reportPublic FDA data

NyQuil VapoCOOL SEVERE

Product NDC
69423-989
11-digit product format
694230989
Labeler code
69423
Product ID
69423-989_5ce1634c-0609-ece7-e063-6394a90a386e
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
2021-03-22
Substance
PHENYLEPHRINE HYDROCHLORIDE; DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN
Active strength
10; 12.5; 20; 650 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

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
NyQuil VapoCOOL SEVERE
Brand name suffix
COLD and FLU plus CONGESTION
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE10 mg/30mL
DOXYLAMINE SUCCINATE12.5 mg/30mL
DEXTROMETHORPHAN HYDROBROMIDE20 mg/30mL
ACETAMINOPHEN650 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
69423-989-08Vicks ® NyQuil™ VapoCOOL™ SEVERE COLD & FLU + CONGESTION Liquid
69423-989-08Vicks ® NyQuil™ VapoCOOL™ SEVERE COLD & FLU + CONGESTION Liquid
69423-989-12Vicks ® NyQuil™ VapoCOOL™ SEVERE COLD & FLU + CONGESTION Liquid
69423-989-12Vicks ® NyQuil™ VapoCOOL™ SEVERE COLD & FLU + CONGESTION Liquid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-989-08NyQuil VapoCOOL SEVERECOLD and FLU plus CONGESTION236 mL in 1 BOTTLE, PLASTICSOLUTION2368
69423-989-12NyQuil VapoCOOL SEVERECOLD and FLU plus CONGESTION354 mL in 1 BOTTLE, PLASTICSOLUTION3548
69423-989-08DayQuil and NyQuil VapoCOOL SEVERECOLD and FLU plus CONGESTION236 mL in 1 BOTTLE, PLASTICSOLUTION236 mL650 mg in 30mL7
69423-989-12DayQuil and NyQuil VapoCOOL SEVERECOLD and FLU plus CONGESTION354 mL in 1 BOTTLE, PLASTICSOLUTION236 mL650 mg in 30mL7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-989DAYQUIL AND NYQUIL VAPOCOOL SEVERE COLD AND FLU PLUS CONGESTION (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY]6Current NDC, Legacy NDC20241114_fbd53e5f-bc03-75b4-e053-6394a90af028.zip
69423-989NYQUIL VAPOCOOL SEVERE COLD AND FLU PLUS CONGESTION (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [THE PROCTER & GAMBLE MANUFACTURING COMPANY]6Current NDC, Legacy NDC, 2 package rows20241012_ef6df67c-0afa-4825-e053-2995a90aced9.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 7 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINCVS PHARMACY3148f80f-8a0d-4b6c-85be-79085fc044442026-08-19WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLRite Aid Corporationaa7164a7-f842-457d-abee-0740bb8c1c902026-08-19WarningsExact identifier
application number: M012
CVSCHILDRENS STUFFY NOSE AND COLDCVS PHARMACY, INC6cff265d-94a3-4617-a366-fe970d97f05a2026-08-19WarningsExact identifier
application number: M012
CVS Severe Congestion and Pain ReliefACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECVS5a8e4320-bae1-4831-b66b-9babfe8888d62026-08-19WarningsExact identifier
application number: M012
CVS Mucus Relief DM Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINCVS PHARMACY0ae0c244-e019-4b35-890c-8e15e3d3f7ce2026-08-19WarningsExact identifier
application number: M012
CVS Severe Tussin CF MaxACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACYe32881f5-2bb5-4756-aa86-a09473ab590b2026-08-19WarningsExact identifier
application number: M012
Good Sense Tussin DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINL. Perrigo Companyd2541ef0-a73c-43aa-91ff-fdbce2748c4f2026-08-18WarningsExact identifier
application number: M012
CVS Severe Nasal Congestion Relief Clear and CoolOXYMETAZOLINE HYDROCHLORIDECVS PHARMACY, INC.5a7e42ee-810c-4bc1-9d8d-fac8e849e1262026-08-18WarningsExact identifier
application number: M012
DAYTIME NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLAmazon.com Services LLC8dd039b4-209a-484a-b15e-741d55087a932026-08-18WarningsExact identifier
application number: M012
CVS Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCLCVS PHARMACY558b7ed6-a9f6-452c-90cd-df8258663bf12026-08-18WarningsExact identifier
application number: M012
Extra Strength NasalPHENYLEPHRINE HYDROCHLORIDECVS PHARMACY7acf1a9a-bd97-48bb-8025-ac26070378a22026-08-18WarningsExact identifier
application number: M012
Polytussin DMDEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, PYRILAMINE MALEATEPoly Pharmaceuticals, Inc.fda8f594-82bf-1781-e053-6294a90ad3442026-08-18WarningsExact identifier
application number: M012
Mucinex Fast-Max DM Max Honey and Berry FlavorDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINReckitt Benckiser LLCda1f1ef9-a974-4998-8e1d-c1d9995969432026-08-18WarningsExact identifier
application number: M012
CVS Health Ultra Fine MistOXYMETAZOLINE HYDROCHLORIDECVS PHARMACY, INC.89168715-71b1-424e-8dae-fcfa90bc85bf2026-08-18WarningsExact identifier
application number: M012
CVS Health SinusOXYMETAZOLINE HYDROCHLORIDECVS PHARMACY, INC.c7840511-3a4f-4547-ae90-19b085a5874e2026-08-17WarningsExact identifier
application number: M012
CVS HealthNASAL OXYMETAZOLINE HCLCVS Pharmacy,Inc.56f08e70-bf16-4933-97bc-177bc190d12a2026-08-17WarningsExact identifier
application number: M012
CVS Health No DripALLERGY NASALCVS PHARMACY,INC.3e76ffac-07a7-4b6a-bc4c-9cabb653e0642026-08-17WarningsExact identifier
application number: M012
CVS dye-free childrens allergyDIPHENHYDRAMINE HYDROCHLORIDECVS PHARMACYdb5a5eff-1bb1-4d00-8c01-caae7a1c72232026-08-17WarningsExact identifier
application number: M012
CVS Overnight Cold and Flu Clear and CoolACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDECVS PHARMACY, INC2497a011-d7a0-4d69-97e2-bbf25a99b1cc2026-08-17WarningsExact identifier
application number: M012
Mucus Relief Cough Cold Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLH E B3ef949f5-ac8c-44be-b04d-6996fa59a94b2026-08-17WarningsExact identifier
application number: M012

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 SolutionPSNef6df67c-0afa-4825-e053-2995a90aced98
1431245acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCDef6df67c-0afa-4825-e053-2995a90aced98
1431245acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSYef6df67c-0afa-4825-e053-2995a90aced98
1431245acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSYef6df67c-0afa-4825-e053-2995a90aced98
1431245APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral SolutionSYef6df67c-0afa-4825-e053-2995a90aced98
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) } PackGPCKfbd53e5f-bc03-75b4-e053-6394a90af0287
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) PackPSNfbd53e5f-bc03-75b4-e053-6394a90af0287
1369842acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSNfbd53e5f-bc03-75b4-e053-6394a90af0287
1431245acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral SolutionPSNfbd53e5f-bc03-75b4-e053-6394a90af0287
1431245acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCDfbd53e5f-bc03-75b4-e053-6394a90af0287
1369842acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCDfbd53e5f-bc03-75b4-e053-6394a90af0287
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) PackSYfbd53e5f-bc03-75b4-e053-6394a90af0287
1431245acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSYfbd53e5f-bc03-75b4-e053-6394a90af0287
1369842acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSYfbd53e5f-bc03-75b4-e053-6394a90af0287
1431245acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSYfbd53e5f-bc03-75b4-e053-6394a90af0287
1369842acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSYfbd53e5f-bc03-75b4-e053-6394a90af0287
1431245APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral SolutionSYfbd53e5f-bc03-75b4-e053-6394a90af0287
1369842APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / Guaifenesin 13.3 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral SolutionSYfbd53e5f-bc03-75b4-e053-6394a90af0287

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69423-989-0869423098908236 mL in 1 BOTTLE, PLASTIC (69423-989-08) 236 ml2021-03-220000-00-00NoNoCurrent
69423-989-1269423098912354 mL in 1 BOTTLE, PLASTIC (69423-989-12) 354 ml2021-03-220000-00-00NoNoCurrent