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 176 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NyQuil Severe Plus VapoCOOL Cold and Flu, TRAVEL BASIXACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDELil' Drug Store Products, Inc.e7355543-6dd7-4560-8fe0-9c1ebd4d2c0b2023-10-02WarningsExact identifier
application number: M012
Guaifenesin DMGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEPD-Rx Pharmaceuticals, Inc.ac8c0c15-b305-47f2-8712-e4b53636f7fa2023-10-02WarningsExact identifier
application number: M012
Maximum strength Day cold and flu and Night severe cold and fluACETAMINOPHE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL TABLETSTIME CAP LABORATORIES,INCfff69901-965c-5372-e053-6394a90a29c22023-09-18WarningsExact identifier
application number: M012
Tussin Mucus and Chest Congestion Sugar FreeGUAIFENESINAARNA USA, Inc.6e488782-0138-436d-a9f0-0ec5bc9daedd2023-05-15WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESINKROGER COMPANY813b1db2-a177-77c6-e053-2a91aa0ac73b2023-01-17WarningsExact identifier
application number: M012
MUCUS RELIEF DMDEXTROMETHORPHAN HBR/GUAIFENESINKROGER COMPANY813baf42-edb0-33a9-e053-2a91aa0a85992023-01-17WarningsExact identifier
application number: M012
Daytime NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEH-E-Bdb19b8c7-0334-0664-e053-2a95a90ad61f2023-01-14WarningsExact identifier
application number: M012
NightimeACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEH-E-Bdb44560b-da02-74c9-e053-2a95a90af0b62023-01-13WarningsExact identifier
application number: M012
DAYTIME COLD AND FLU Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCLWalgreensdbf5656b-9105-871b-e053-2995a90a49412023-01-03WarningsExact identifier
application number: M012
DAYTIME-NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLKROGERa2508699-08c0-4a22-e053-2a95a90a8a6d2022-11-02WarningsExact identifier
application number: M012
GUAIFENESINGUAIFENESINPAI Holdings, LLC dba PAI Pharmac2e53fb5-2798-47c8-9285-d1077d46e6292022-06-14WarningsExact identifier
application number: M012
Mucus Relief DMMUCUS RELIEF DMTopCo Associates, LLC71674a9b-89ed-43d1-aadb-b9311fdfbdf92022-06-07WarningsExact identifier
application number: M012
Daytime Nighttime Cold and Flu Relief Combo PackDAYTIME NIGHTTIME COLD AND FLUAllegiant Healthfa7ed5db-4da7-46b4-a08d-1d79cb7a56742022-05-19WarningsExact identifier
application number: M012
Mucus Relief DM Immediate ReleaseMUCUS RELIEF DMGood Sense26a199bf-57e5-4f36-b40c-83a1187e48702022-05-18WarningsExact identifier
application number: M012
Mucus Relief DM Immediate ReleaseMUCUS RELIEF DMAllegiant Health731f8608-ad5b-491e-a4d4-2bb0c423fed52022-05-18WarningsExact identifier
application number: M012
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HClACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLOPMX LLCb3c229a4-c772-70fb-e053-2a95a90a72db2022-03-11WarningsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATEGood Sensef88e2654-8e97-4cf6-9c36-01aeb51a91022021-11-30WarningsExact identifier
application number: M012
Cold MedicineCOLD MEDICINEAllegiant Health443fbc44-2c33-4316-ad31-dcc5a5aa8f522021-11-23WarningsExact identifier
application number: M012
Decongestant PE Non DrowsyPHENYLEPHRINE HCLAllegiant Health7a3098b4-381c-4f32-97a7-87b53fd644282021-06-16WarningsExact identifier
application number: M012
Mucus Relief Immediate ReleaseGUAIFENESIN 400MGGood Sensee7c68746-7ec0-46cf-b4a3-174fab819b5e2021-05-05WarningsExact 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