FDA.reportPublic FDA data

Vicks PainQuil PM

Product NDC
69423-834
11-digit product format
694230834
Labeler code
69423
Product ID
69423-834_5d19191e-0d66-d40a-e063-6394a90a8563
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-07
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN
Active strength
50; 1000 mg/30mL; mg/30mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [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
Vicks PainQuil PM
Brand name suffix
PAIN RELIEVER plus NIGHTTIME SLEEP-AID
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/30mL
ACETAMINOPHEN1000 mg/30mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
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90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
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cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-834-12Vicks PainQuil PMPAIN RELIEVER plus NIGHTTIME SLEEP-AID354 mL in 1 BOTTLELIQUID3548
69423-834-12Vicks PainQuil and Vicks PainQuil PMPAIN RELIEVER354 mL in 1 BOTTLELIQUID354 mL in 250 mg in 30mL8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-834VICKS PAINQUIL AND VICKS PAINQUIL PM PAIN RELIEVER (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY]6Current NDC20250213_163a1617-b7f1-4c80-e063-6394a90a74c3.zip
69423-834VICKS PAINQUIL PM PAIN RELIEVER PLUS NIGHTTIME SLEEP-AID (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) LIQUID [THE PROCTER & GAMBLE MANUFACTURING COMPANY]6Current NDC, 1 package rows20241220_65803fcd-3f5b-4c9d-85a1-2bf03ed6f68d.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 72 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Excedrin Extra Strength Pain RelieverACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINEHaleon US Holdings LLC691b754c-bafc-47e2-a322-cf56245c01f62024-03-14WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENCVS PHARMACY, INCfdc80b2a-d7c1-4b3d-9a9b-28182c6320de2024-03-14WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENQUALITY CHOICE (Chain Drug Marketing Association)2cde052d-22a4-470f-8d6a-7c17061b8ac82024-03-14WarningsExact identifier
application number: M013
Excedrin Tension HeadacheACETAMINOPHEN, CAFFEINEHaleon US Holdings LLC12c074d1-81ac-47d2-8747-b018cda0058a2024-03-13WarningsExact identifier
application number: M013
Menstrual CompleteACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEStrive Pharmaceuticals Inc.78c12459-3b27-4ed0-943d-520794eb438d2024-03-07WarningsExact identifier
application number: M013
Pain Reliever fever Reducer Extra StrengthACETAMINOPHENCVS Pharmacy7b5263ad-01b7-4fc5-9384-4da8efe89e352024-03-06WarningsExact identifier
application number: M013
Excedrin Extra Strength GeltabsACETAMINOPHEN, ASPRIN, CAFFEINEHaleon US Holdings LLC11a8439b-0159-4351-b0f5-fe7fad6a33c02024-03-05WarningsExact identifier
application number: M013
Winco Foods Effervescent Pain ReliefASPIRINWinco Foods, LLC128afdd7-a9d1-8957-e063-6294a90af5692024-03-05WarningsExact identifier
application number: M013
Aspirin Low Dose Safety CoatedASPIRINCare One (Retail Business Services, LLC.)6659e103-fa03-4de0-af42-d2fbd548a87c2024-03-05WarningsExact identifier
application number: M013
Dolex Children Pain and FeverACETAMINOPHENPharmadel LLCf9158463-aeb1-5de0-e053-6294a90a748b2024-03-04WarningsExact identifier
application number: M013
SEDALMEX FORTEACETAMINOPHEN, ASPIRIN, CAFFEINEBelmora LLC33b3508e-4caa-4d05-9b15-cb82a2ee2d4d2024-02-28WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENAMERISOURCE BERGEN2b923a97-836c-4dac-a8c0-3047a35fb62e2024-02-23WarningsExact identifier
application number: M013
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLBJWC (Berkley & Jensen / BJ's)b20a08f3-c9c0-4bd9-8ce0-acb932b5bb862024-02-22WarningsExact identifier
application number: M013
M-PAPACETAMINOPHENBryant Ranch Prepack31a41976-7f65-42d7-acf5-de9c2c5ca58e2024-02-20WarningsExact identifier
application number: M013
Publix Fast Relief Effervescent - Original FlavorASPIRINPUBLIX SUPER MARKETS INC.0a342f72-45fd-3e12-e063-6394a90ae33e2024-02-16WarningsExact identifier
application number: M013
Equaline Effervescent Pain RelieverASPIRINUNITED NATURAL FOODS, INC. DBA UNFI0761299a-e913-7665-e063-6394a90a60032024-02-16WarningsExact identifier
application number: M013
TopCare Effervescent Pain ReliefASPIRINTOPCO ASSOCIATES LLC075f36e1-110c-e839-e063-6294a90a89d72024-02-16WarningsExact identifier
application number: M013
Extra Strength Pain RelieverACETAMINOPHENINGLES MARKETS, INC.115d0b4f-6f0f-79a9-e063-6394a90ab18a2024-02-14WarningsExact identifier
application number: M013
PANADOLACETAMINOPHENHaleon US Holdings LLCe1799765-c247-42b4-ad6a-8ba7d136abf22024-02-06WarningsExact identifier
application number: M013
Panadol Cold and Flu NonDrowsyACETAMINOPHEN AND PHENYLEPRINE HCLHaleon US Holdings LLCf626ab17-01c9-4493-ba9e-0c8c111463842024-02-06WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2681010{1 (acetaminophen 33.3 MG/ML / diphenhydramine hydrochloride 1.67 MG/ML Oral Solution) / 1 (acetaminophen 33.3 MG/ML Oral Solution) } PackGPCK163a1617-b7f1-4c80-e063-6394a90a74c38
26810101 nighttime (acetaminophen 1000 MG / diphenhydrAMINE HCl 50 MG in 30 mL Oral Solution) / 1 daytime (acetaminophen 1000 MG in 30 mL Oral Solution) PackPSN163a1617-b7f1-4c80-e063-6394a90a74c38
1092373acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG in 15 mL Oral SolutionPSN65803fcd-3f5b-4c9d-85a1-2bf03ed6f68d8
1092373acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG in 15 mL Oral SolutionPSN163a1617-b7f1-4c80-e063-6394a90a74c38
307684acetaminophen 500 MG in 15 mL Oral SolutionPSN163a1617-b7f1-4c80-e063-6394a90a74c38
1092373acetaminophen 33.3 MG/ML / diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCD163a1617-b7f1-4c80-e063-6394a90a74c38
1092373acetaminophen 33.3 MG/ML / diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCD65803fcd-3f5b-4c9d-85a1-2bf03ed6f68d8
307684acetaminophen 33.3 MG/ML Oral SolutionSCD163a1617-b7f1-4c80-e063-6394a90a74c38
26810101 nighttime (acetaminophen 1000 MG / diphenhydramine HCl 50 MG per 30 mL Oral Solution) / 1 daytime (acetaminophen 1000 MG per 30 mL Oral Solution) PackSY163a1617-b7f1-4c80-e063-6394a90a74c38
1092373acetaminophen 1000 MG / diphenhydramine HCl 50 MG per 30 ML Oral SolutionSY163a1617-b7f1-4c80-e063-6394a90a74c38
1092373acetaminophen 1000 MG / diphenhydramine HCl 50 MG per 30 ML Oral SolutionSY65803fcd-3f5b-4c9d-85a1-2bf03ed6f68d8
1092373acetaminophen 500 MG / diphenhydramine HCl 25 MG per 15 ML Oral SolutionSY163a1617-b7f1-4c80-e063-6394a90a74c38
1092373acetaminophen 500 MG / diphenhydramine HCl 25 MG per 15 ML Oral SolutionSY65803fcd-3f5b-4c9d-85a1-2bf03ed6f68d8
307684APAP 1000 MG per 30 ML Oral SolutionSY163a1617-b7f1-4c80-e063-6394a90a74c38
307684APAP 167 MG per 5 ML Oral SolutionSY163a1617-b7f1-4c80-e063-6394a90a74c38
1092373APAP 33.3 MG/ML / Diphenhydramine Hydrochloride 1.67 MG/ML Oral SolutionSY163a1617-b7f1-4c80-e063-6394a90a74c38
1092373APAP 33.3 MG/ML / Diphenhydramine Hydrochloride 1.67 MG/ML Oral SolutionSY65803fcd-3f5b-4c9d-85a1-2bf03ed6f68d8
307684APAP 33.3 MG/ML Oral SolutionSY163a1617-b7f1-4c80-e063-6394a90a74c38
307684APAP 500 MG per 15 ML Oral SolutionSY163a1617-b7f1-4c80-e063-6394a90a74c38

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69423-834-1269423083412354 mL in 1 BOTTLE (69423-834-12) 354 ml2024-05-07NoNoCurrent
69423-834-24694230834242 BOTTLE in 1 CELLO PACK (69423-834-24) / 354 mL in 1 BOTTLE2 bottle2026-08-03NoNoCurrent