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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16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
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ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
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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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cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
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 70 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength Pain RelieverACETAMINOPHEN, ASPIRIN, AND CAFFEINEJHK Inc dba American Safety & First Aid87c5ad71-0448-4e0f-acee-bf9a1d38675e2024-04-25WarningsExact identifier
application number: M013
dg health childrens pain and feverACETAMINOPHENDolgencorp Inc49b2ac72-86a3-4783-bf51-8c1a222e457e2024-04-25WarningsExact identifier
application number: M013
basic care infants pain and feverACETAMINOPHENAmazon.com Services LLCdab1f9e6-3875-4d53-a417-c6a78274ee562024-04-23WarningsExact identifier
application number: M013
Excedrin Extra Strength Pain RelieverACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINEHaleon US Holdings LLCa71074a6-cc19-4bb3-8c84-4e82a89068012024-04-22WarningsExact identifier
application number: M013
Regular Strength AcetaminophenACETAMINOPHENKROGER COMPANY0fe995cd-f974-db04-e063-6294a90a33552024-04-18WarningsExact identifier
application number: M013
Regular Strength Aspirin 325 mgASPIRINKroger0fc3193d-af4e-ff3a-e063-6294a90a27432024-04-17WarningsExact identifier
application number: M013
Childrens Pain and Fever Dye FreeACETAMINOPHENKROGER COMPANY0fec66b4-3a2a-63d1-e063-6294a90a6d722024-04-17WarningsExact identifier
application number: M013
aspirin low dose chewableASPIRINTime-Cap Labs, Inc5d56618c-8ea2-42ea-a9f2-339bd0055ddd2024-04-17WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINP & L Development, LLC0058175f-3474-40c3-a046-6cfaec86d84b2024-04-16WarningsExact identifier
application number: M013
Handy Solutions Headache Pain ReliefACETAMINOPHEN, ASPIRIN, CAFFEINENavajo Manufacturing Company Inc.e5481abe-6971-2bc5-e053-2995a90ae8952024-04-15WarningsExact identifier
application number: M013
childrens acetaminophenACETAMINOPHENMajor Pharmaceuticals243a5cff-e506-434b-ab19-1a6ac53f85332024-04-15WarningsExact identifier
application number: M013
Dye Free Pain Reliever ChildrensACETAMINOPHENP & L Development, LLC45ddcaad-d416-4d7c-a84a-43548d5c5d3b2024-04-15WarningsExact identifier
application number: M013
Tylenol Extra StrengthACETAMINOPHENNavajo Manufacturing Company Inc.65bf1556-f25a-9439-e053-2a91aa0a31942024-04-15WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENKroger Companybbeebdd6-fe2c-5b8a-e053-2a95a90ab95e2024-04-13WarningsExact identifier
application number: M013
infants pain reliefACETAMINOPHENPublix Super Markets Inc3d1818a7-d3b2-434c-b3c9-b2713f08ded22024-04-13WarningsExact identifier
application number: M013
Mommys Bliss Childrens Pain and FeverACETAMINOPHENMom Enterprises, LLC.08b9eaf7-70d1-640f-e063-6394a90a8d3b2024-04-12WarningsExact identifier
application number: M013
Mommys Bliss Infants Pain and FeverACETAMINOPHENMom Enterprises, LLC.05e26650-81b3-d7b1-e063-6394a90a14ed2024-04-11WarningsExact identifier
application number: M013
Childrens Pain ReliefCHILDRENS PAIN RELIEFAllegiant Health7381dd26-c507-4d02-b989-cfd96e02f4952024-04-11WarningsExact identifier
application number: M013
Childrens Pain Relief Dye-FreeACTEAMINOPHENWinCo Foods, LLC5ee134b3-b8e9-4621-b0a1-a84d9867ccba2024-04-11WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENWALGREENS0b1d086f-7be1-5072-e063-6394a90a11e62024-04-10WarningsExact 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