FDA.reportPublic FDA data

NyQuil Cold and Flu w/VapoCOOL, 4ct

Product NDC
85237-1917
Requested package NDC
85237-1917-1
11-digit product format
852371917
Labeler code
85237
Product ID
85237-1917_5e1687ef-4d22-558e-e063-6294a90a4bf5
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, doxylamine succinate, dextromethorphan hydrobromide tablet, coated
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Select Consumer Group
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-01
Substance
DOXYLAMINE SUCCINATE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
6.25; 325; 10 mg/1; mg/1; mg/1
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
NyQuil Cold and Flu w/VapoCOOL, 4ct
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYLAMINE SUCCINATE6.25 mg/1
ACETAMINOPHEN325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1

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 12 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dg health cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp Inc3d8ce88e-9f40-4b58-a811-160ddbfb81122026-08-04WarningsExact identifier
application number: M012
ValuRx Dye Free Allergy ReliefDIPHENHYDRAMINE HCL 25 MGShield Pharmaceuticals Corpca60a413-b02e-48ce-985d-4d415780c6792026-08-04WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRRite Aid Corporation20af2586-f8ac-47a3-9f8d-de255f9193282026-08-04WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWal-Mart Stores Inc150b68ba-3ed4-4533-9118-74e76eaf6e482026-08-04WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLRite Aid Corporationce393bff-498b-42e6-a41c-bbfbc58fb42c2026-08-04WarningsExact identifier
application number: M012
Sinus and HeadacheACETAMINOPHEN AND PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader3b8662bf-3abb-4e54-af9c-5fa1d2e190032026-08-04WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRFamily Dollar Services Inc74ee96f7-75ac-4b60-a2b8-13b050e238042026-08-04WarningsExact identifier
application number: M012
Mucus Relief PEGUAIFENESIN, PHENYLEPHRINE HCLWalgreen Companycb1c1922-5dc6-520d-e77e-e951726d97012026-08-04WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRDOLGENCORP, LLC7a662caf-9cbb-4d55-b0b2-43f1f1289ec72026-08-04WarningsExact identifier
application number: M012
Chest Congestion Relief DMDEXTROMETHORPHAN HBR, GUAIFENESINDOLGENCORP, LLCda053bc3-e790-4ae9-a406-2629640e97e72026-08-04WarningsExact identifier
application number: M012
Cold and Flu Daytime, Nighttime, Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company4d199dc7-253f-48fd-a77d-f8b10f724dd12026-08-04WarningsExact identifier
application number: M012
daytime nitetime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLMeijer Distribution Inc80aae1c3-a616-442b-842e-177db957a69c2026-08-04WarningsExact identifier
application number: M012
Mucus Relief DGUAIFENESIN, PSEUDOEPHEDRINE HCLMeijer Distribution Inc383281d7-0d25-4423-ace2-d2985f2c37d02026-08-03WarningsExact identifier
application number: M012
equaline daytime and nighttime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI8fc2389c-9657-4dbe-a32b-df8245fc67ca2026-08-03WarningsExact identifier
application number: M012
Acetominophen, Dextromethorphan hydrobromideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDESoftgel Healthcare Private Limited5302bc6d-d947-31c3-e063-6294a90a09f32026-08-03WarningsExact identifier
application number: M012
MUCINEX INSTASOOTHE COUGHDEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC0d99237c-0b52-0af6-e063-6394a90aba142026-08-03WarningsExact identifier
application number: M012
daytime nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company182a105b-bd49-42b5-b4e0-46e5ec0197e32026-08-03WarningsExact identifier
application number: M012
equaline nighttime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEUnited Natural Foods, Inc. dba UNFI05e089e7-8772-4bf4-914f-6a26067ee7192026-08-03WarningsExact identifier
application number: M012
AllergyCHLORPHENIRAMINE MALEATEMajor Pharmaceuticals66b918d3-5c37-4889-b981-819ced8b61472026-08-03WarningsExact identifier
application number: M012
Tukol Max Action Cold and Flu Nighttime ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEGenomma Lab USAcf0987a3-2c1d-4f40-8551-df9a8e08cd3d2026-08-03WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85237-1917-1852371917011 POUCH in 1 CARTON (85237-1917-1) / 2 TABLET, COATED in 1 POUCH (85237-1917-0) 1 pouch2025-06-01NoNoCurrent