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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88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
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a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
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06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
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20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
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816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
377068df-225f-7318-a910-a1987cdfa361Product name320170608
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
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 55 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACETAMINOPHEN (RED)ACETAMINOPHENHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltda352f588-4a70-42b2-8f9c-a73a0629517d2024-11-25WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.5c42dd28-820c-4cc5-9016-11ad5e5806162024-11-25WarningsExact identifier
application number: M013
equate pain relieverACETAMINOPHENWALMART INC.4518fe82-3ba8-4e9e-a036-776df7fb8d572024-11-21WarningsExact identifier
application number: M013
Family Wellness Pain RelieverASPIRINFAMILY WELLNESS SERVICES, INC.075e19f4-1a58-aedd-e063-6294a90af7082024-11-20WarningsExact identifier
application number: M013
MejoralitoACETAMINOPHENOPMX Chula Vistafd2ecde0-296e-060f-e053-6294a90afd982024-11-15WarningsExact identifier
application number: M013
Temp XACETAMINOPHENOPMX Chula Vistafd2edc32-0351-c991-e053-6294a90ab4ce2024-11-15WarningsExact identifier
application number: M013
CVS Health Extra Strength Antacid and Pain RelieverASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATECVS Pharmacyafe9e755-18ba-305f-e053-2995a90aa8d02024-11-14WarningsExact identifier
application number: M013
Walgreens Effervescent Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEWalgreens667418fc-a3ab-cbc7-e053-2a91aa0a20232024-11-13WarningsExact identifier
application number: M013
Up and Up Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATETarget Corporationa72eef45-b985-638a-e053-2995a90aa20a2024-11-13WarningsExact identifier
application number: M013
Signature Care Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATESafeway, Inc6e120024-475a-73af-e053-2a91aa0a42a62024-11-13Warnings, Adverse reactionsExact identifier
application number: M013
Kroger Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEKroger Company6d858b0e-a3c8-2686-e053-2991aa0acc062024-11-13WarningsExact identifier
application number: M013
TopCare Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATETopco Associates LLC639f9d57-f26a-708a-e053-2a91aa0a69622024-11-13Warnings, Adverse reactionsExact identifier
application number: M013
Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEH. E. Butt Grocery Company6418cde9-607b-4ca1-e053-2991aa0a91702024-11-13WarningsExact identifier
application number: M013
Bromo SeltzerASPIRIN, SODIUM BICARBONATE, CITRIC ACIDTower Laboratories Ltd8ff88ee1-e33e-4051-992f-24e2720c48ce2024-11-13WarningsExact identifier
application number: M013
Care One Original Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEFoodhold U.S.A.8f662c51-d2fa-6458-e053-2995a90ac6fd2024-11-13WarningsExact identifier
application number: M013
Top Value Effervescent Pain ReliefAPIRIN, CITRIC ACID, SODIUM BICARBONATETower Laboratories Ltd43c7f435-735c-3fab-e054-00144ff88e882024-11-13Warnings, Adverse reactionsExact identifier
application number: M013
DG Health Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEDOLGENCORP, INC8f1343d5-2884-3a14-e053-2a95a90a2f902024-11-13WarningsExact identifier
application number: M013
Good Sense Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEGood Sensecd25b0c3-0134-beef-e053-2a95a90a092b2024-11-13WarningsExact identifier
application number: M013
Drug Mart Effervescent Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEDiscount Drug Mart, Inc8bc65603-1dbf-30ab-e053-2995a90a7c152024-11-13WarningsExact identifier
application number: M013
Best Choice Effervescent Antacid Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEValu Merchandisers Company8aab905b-5fe7-dddb-e053-2995a90a6c6f2024-11-13WarningsExact 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