FDA.reportPublic FDA data

Vicks PainQuil PM

Product NDC
84126-350
11-digit product format
841260350
Labeler code
84126
Product ID
84126-350_32bee530-bd27-4c40-e063-6394a90a1832
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-06
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
1000; 50 mg/30mL; mg/30mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Vicks PainQuil PM
Brand name suffix
PAIN RELIEVER plus NIGHTTIME SLEEP-AID
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, TC2D6JAD40
Rxcui1092373

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
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
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
377068df-225f-7318-a910-a1987cdfa361Product name320170608
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-350-12Vicks PainQuil and Vicks PainQuil PMPAIN RELIEVER354 mL in 1 BOTTLELIQUID354 mL50 mg in 30mL2
84126-350-12Vicks PainQuil PMPAIN RELIEVER plus NIGHTTIME SLEEP-AID354 mL in 1 BOTTLELIQUID3541

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84126-350VICKS PAINQUIL AND VICKS PAINQUIL PM PAIN RELIEVER (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY]2Current NDC20250507_334f3194-9737-8f85-e063-6394a90ad416.zip
84126-350VICKS PAINQUIL PM PAIN RELIEVER PLUS NIGHTTIME SLEEP-AID (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) LIQUID [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1Current NDC, 1 package rows20250507_32bedbbc-b939-1bea-e063-6394a90a6934.zip

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) } PackGPCK334f3194-9737-8f85-e063-6394a90ad4162
26810101 nighttime (acetaminophen 1000 MG / diphenhydrAMINE HCl 50 MG in 30 mL Oral Solution) / 1 daytime (acetaminophen 1000 MG in 30 mL Oral Solution) PackPSN334f3194-9737-8f85-e063-6394a90ad4162
1092373acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG in 15 mL Oral SolutionPSN334f3194-9737-8f85-e063-6394a90ad4162
307684acetaminophen 500 MG in 15 mL Oral SolutionPSN334f3194-9737-8f85-e063-6394a90ad4162
1092373acetaminophen 33.3 MG/ML / diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCD334f3194-9737-8f85-e063-6394a90ad4162
307684acetaminophen 33.3 MG/ML Oral SolutionSCD334f3194-9737-8f85-e063-6394a90ad4162
26810101 nighttime (acetaminophen 1000 MG / diphenhydramine HCl 50 MG per 30 mL Oral Solution) / 1 daytime (acetaminophen 1000 MG per 30 mL Oral Solution) PackSY334f3194-9737-8f85-e063-6394a90ad4162
1092373acetaminophen 1000 MG / diphenhydramine HCl 50 MG per 30 ML Oral SolutionSY334f3194-9737-8f85-e063-6394a90ad4162
1092373acetaminophen 500 MG / diphenhydramine HCl 25 MG per 15 ML Oral SolutionSY334f3194-9737-8f85-e063-6394a90ad4162
307684APAP 1000 MG per 30 ML Oral SolutionSY334f3194-9737-8f85-e063-6394a90ad4162
307684APAP 167 MG per 5 ML Oral SolutionSY334f3194-9737-8f85-e063-6394a90ad4162
1092373APAP 33.3 MG/ML / Diphenhydramine Hydrochloride 1.67 MG/ML Oral SolutionSY334f3194-9737-8f85-e063-6394a90ad4162
307684APAP 33.3 MG/ML Oral SolutionSY334f3194-9737-8f85-e063-6394a90ad4162
307684APAP 500 MG per 15 ML Oral SolutionSY334f3194-9737-8f85-e063-6394a90ad4162
1092373acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG in 15 mL Oral SolutionPSN32bedbbc-b939-1bea-e063-6394a90a69341
1092373acetaminophen 33.3 MG/ML / diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCD32bedbbc-b939-1bea-e063-6394a90a69341
1092373acetaminophen 1000 MG / diphenhydramine HCl 50 MG per 30 ML Oral SolutionSY32bedbbc-b939-1bea-e063-6394a90a69341
1092373acetaminophen 500 MG / diphenhydramine HCl 25 MG per 15 ML Oral SolutionSY32bedbbc-b939-1bea-e063-6394a90a69341
1092373APAP 33.3 MG/ML / Diphenhydramine Hydrochloride 1.67 MG/ML Oral SolutionSY32bedbbc-b939-1bea-e063-6394a90a69341

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-350-1284126035012354 mL in 1 BOTTLE (84126-350-12) 354 ml2025-05-06NoNoCurrent