FDA.reportPublic FDA data

Vicks ZzzQuil

Product NDC
69423-985
11-digit product format
694230985
Labeler code
69423
Product ID
69423-985_5ce1528e-c80e-5007-e063-6294a90a02f1
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride and Acetaminophen
Dosage form
LIQUID
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-03
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 ZzzQuil
Brand name suffix
Night Pain
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
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-985-02Vicks ZzzQuilNight Pain2 in 1 CARTONLIQUID29
69423-985-02Vicks ZzzQuilNight Pain354 mL in 1 BOTTLELIQUID3549
69423-985-12Vicks ZzzQuilNight Pain354 mL in 1 BOTTLELIQUID3549

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-985VICKS ZZZQUIL NIGHT PAIN (DIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHEN) LIQUID [THE PROCTER & GAMBLE MANUFACTURING COMPANY]5Current NDC, 3 package rows20241012_f3bb75e8-3d43-f91e-e053-2a95a90a584d.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 9 of 13 · 259 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime Sleep AidDIPHENHYDRAMINE HCLTOP CARE (Topco Associates LLC)027d7eff-6c83-40f1-9716-231637cdbeba2025-06-12WarningsExact identifier
application number: M010
Nighttime Sleep Aid maximum strengthDIPHENHYDRAMINE HCLCardinal Health (Leader) 70000546e4fda-6eb2-4358-840e-e2473bf7f3522025-06-03WarningsExact identifier
application number: M010
Simply SleepDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC37c606b0-04d5-49f0-886a-3ee2c9b0e9cc2025-06-02WarningsExact identifier
application number: M010
Sleep Aid Maximum StrengthDIPHENHYDRAMINE HCLWinCo Foods, LLCe9bc5a16-b1fc-4585-8f3b-30ccf43004922025-05-30WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLCare One (Retail Business Services, LLC.)51e633a8-5bfc-4ff9-816f-3bc22b8a5c4c2025-05-23WarningsExact identifier
application number: M010
Nighttime Sleep Aid Maximum StrengthDIPHENHYDRAMINE HCLCare One (Retail Business Services, LLC.)536cd7d6-a470-4614-89c8-6c3ada582a902025-05-23WarningsExact identifier
application number: M010
Diphenhydramine HClDIPHENHYDRAMINE HCLBI-MART2914504a-ed42-4168-9e5c-f49407ed5a302025-05-20WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLCardinal Health (Leader) 70000133d6f38-9de7-4104-8175-3933b263afe02025-05-16WarningsExact identifier
application number: M010
Nighttime Sleep-aidDIPHENHYDRAMINE HCLNORTHEAST PHARMAd2062094-d1b5-38ab-e053-2995a90a56702025-05-15WarningsExact identifier
application number: M010
Nighttime Sleep-aidDIPHENHYDRAMINE HCLGeri-Care Pharmaceutical Corp0fce381f-28ef-4591-a569-c5d599a3b95f2025-05-14WarningsExact identifier
application number: M010
Rest SimplyDIPHENHYDRAMINE HYDROCHLORIDEChain Drug Marketing Association54bdb6bc-622c-412a-8365-a1b1c968e13e2025-05-01WarningsExact identifier
application number: M010
Diphenhydramine HCl Maximum StrengthDIPHENHYDRAMINE HCLBi-Martb89c80aa-27ae-4fce-b574-8ee64bbae2752025-05-01WarningsExact identifier
application number: M010
Sleep Aid NighttimeDIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFI217a211e-b8bf-4119-a094-0e5e733d0b182025-04-21WarningsExact identifier
application number: M010
Vicks PainQuil PM PAIN RELIEVER plus NIGHTTIME SLEEP-AIDACETAMINOPHEN, DIPHENHYDRAMINE HCLThe Procter & Gamble Manufacturing Company32bedbbc-b939-1bea-e063-6394a90a69342025-04-14WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLQUALITY CHOICE (Chain Drug Marketing Association)25f32a1c-0687-45e9-8142-96cf635990902025-04-03WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLFSA Store Inc. (Caring Mills)9d32a3a1-9528-4de4-9fd1-1d01a1ad93e92025-03-28WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLWR Group, Inc.d28d0f6d-8029-4e31-b417-4f8f864d840e2025-03-28WarningsExact identifier
application number: M010
Sleep Aid NightTimeDIPHENHYDRAMINE HCLP & L Development, LLC4144b1a6-aeae-4560-a997-b07206d803502025-03-24WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLStrategic Sourcing Services LLCa512413c-639b-4846-b016-332a78b50ab72025-03-21WarningsExact identifier
application number: M010
Diphenhydramine HClDIPHENHYDRAMINE HCLPD-Rx Pharmaceuticals, Inc.1ee41c86-6767-43ca-a5bb-fc685fa662cd2025-03-20WarningsExact identifier
application number: M010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092373acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG in 15 mL Oral SolutionPSNf3bb75e8-3d43-f91e-e053-2a95a90a584d9
1092373acetaminophen 33.3 MG/ML / diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCDf3bb75e8-3d43-f91e-e053-2a95a90a584d9
1092373acetaminophen 1000 MG / diphenhydramine HCl 50 MG per 30 ML Oral SolutionSYf3bb75e8-3d43-f91e-e053-2a95a90a584d9
1092373acetaminophen 500 MG / diphenhydramine HCl 25 MG per 15 ML Oral SolutionSYf3bb75e8-3d43-f91e-e053-2a95a90a584d9
1092373APAP 33.3 MG/ML / Diphenhydramine Hydrochloride 1.67 MG/ML Oral SolutionSYf3bb75e8-3d43-f91e-e053-2a95a90a584d9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69423-985-02694230985022 BOTTLE in 1 CARTON (69423-985-02) / 354 mL in 1 BOTTLE2 bottle2023-03-03NoNoCurrent
69423-985-1269423098512354 mL in 1 BOTTLE (69423-985-12) 354 ml2023-03-03NoNoCurrent