FDA.reportPublic FDA data

DayQuil and NyQuil VapoCOOL SEVERE

Product NDC
69423-991
11-digit product format
694230991
Labeler code
69423
Product ID
69423-991_5ce167c1-afb2-fecc-e063-6394a90ae5a7
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Guaifenesin, Phenylephrine hydrochloride
Dosage form
KIT
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-22
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
DayQuil and NyQuil VapoCOOL SEVERE
Brand name suffix
COLD and FLU plus CONGESTION
Listing expiration
2027-12-31

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
69423-989-08DayQuil 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
69423-990-08DayQuil and NyQuil VapoCOOL SEVERECOLD and FLU plus CONGESTION236 mL in 1 BOTTLE, PLASTICSOLUTION236 mL650 mg in 30mL7
69423-990-12DayQuil and NyQuil VapoCOOL SEVERECOLD and FLU plus CONGESTION354 mL in 1 BOTTLE, PLASTICSOLUTION236 mL650 mg in 30mL7
69423-991-24DayQuil and NyQuil VapoCOOL SEVERECOLD and FLU plus CONGESTION1 in 1 PACKAGEKIT17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-991DAYQUIL 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, 5 package rows20241114_fbd53e5f-bc03-75b4-e053-6394a90af028.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 156 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Signature Care Nasal DecongestantOXYMETAZOLINE HCLSafeway23f0a5b3-59ae-4eb3-9b7d-e6a4920603372024-08-27WarningsExact identifier
application number: M012
DG Health NasalOXYMETAZOLINE HYDROCHLORIDEDolgencorp, LLCdebcda99-c605-4941-b873-9e4dbae274832024-08-27WarningsExact identifier
application number: M012
Good Neighbor Pharmacy NasalOXYMETAZOLINE HCLAmerisource Bergend374d697-2b57-4558-a20b-d3d89aea82d72024-08-27WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HCLMeijer Distribution Inc3984cbc3-b60c-40a7-bc3a-7d1f600503ac2024-08-27WarningsExact identifier
application number: M012
foster and thrive nasalOXYMETAZOLINE HYDROCHLORIDEStrategic Sourcing Services LLCe6e51821-03ae-4ec3-82a9-b4a8feacd9962024-08-27WarningsExact identifier
application number: M012
Pyrilamine Maleate and Dextromethorphan HydrobromidePYRILAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDEWestminster Pharmaceuticals, LLCdd068449-9d24-41e6-8a6e-f69c9fe263f22024-08-26WarningsExact identifier
application number: M012
basic care nasalOXYMETAZOLINE HYDROCHLORIDEAmazon.com Services LLCa154e500-2b45-4242-a26c-9530849f99df2024-08-23WarningsExact identifier
application number: M012
Daytime Nighttime Ultra Concentrated Cold and FluDAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCL AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATETARGET CORPORATION0c0cf76f-2dd3-45ef-e063-6394a90a9fef2024-08-22WarningsExact identifier
application number: M012
Day Cold and Flu and Night Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCLTARGET CORPORATION08ee56d1-b11d-3e36-e063-6294a90acd5f2024-08-22WarningsExact identifier
application number: M012
Maximum Strength Daytime Cold and Flu and Nighttime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE,TRIPROLIDINE HYDROCHLORIDETARGET CORPORATION0fc523ce-55a7-6384-e063-6394a90aad3f2024-08-22WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWalgreens8045aef9-22bc-4146-b494-dbb1ffef06df2024-08-19WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.5a2053d4-9c0d-4613-9cf5-0067173f37302024-08-16WarningsExact identifier
application number: M012
QUALITY CHOICE Long Acting Cough SoftgelDEXTROMETHORPHAN HYDROBROMIDEChain Drug Marketing Association, Inc.f1ea7dfc-c605-45a1-ad1d-6e636a8a7b1c2024-08-16WarningsExact identifier
application number: M012
pseudoephedrine hydrochloridePSEUDOEPHEDRINE HCLPadagis Israel Pharmaceuticals Ltd458594e1-8d99-4de3-8923-2fd8ce2fc4062024-08-16WarningsExact identifier
application number: M012
Halls Sugar Free Mountain MentholMENTHOLMondelez Global LLC54e0d57e-1f48-45e2-86b3-0e50775996f42024-08-15WarningsExact identifier
application number: M012
SanaTos X ChildrenACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCIPharmadel LLC1fc1408c-c540-39ab-e063-6394a90aa4772024-08-15WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLNuCare Pharmaceuticals, Inc.489645ad-d7da-5f52-e054-00144ff8d46c2024-08-14WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDERite Aid Corporation6c949602-e0c8-40ce-8fb3-5147f406fa042024-08-14WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLNuCare Pharmaceuticals, Inc.3dbdf020-ca17-1197-e054-00144ff8d46c2024-08-13WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.445e49a2-6ed0-434c-aaea-3ce14bc7df592024-08-12WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 startSampleExclude flagStatus
69423-989-0869423098908236 mL in 1 BOTTLE, PLASTIC236 mlHistorical
69423-989-1269423098912354 mL in 1 BOTTLE, PLASTIC354 mlHistorical
69423-990-0869423099008236 mL in 1 BOTTLE, PLASTIC236 mlHistorical
69423-990-1269423099012354 mL in 1 BOTTLE, PLASTIC354 mlHistorical
69423-991-24694230991241 KIT in 1 PACKAGE (69423-991-24) * 354 mL in 1 BOTTLE, PLASTIC (69423-990-12) * 354 mL in 1 BOTTLE, PLASTIC (69423-989-12) * 236 mL in 1 BOTTLE, PLASTIC (69423-990-08) * 236 mL in 1 BOTTLE, PLASTIC (69423-989-08) 1 kit2021-03-22NoNoCurrent