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 3 of 13 · 259 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime Sleep AidDIPHENHYDRAMINE HCLFamily Dollar Services Inc2d63400b-43ae-4dd2-b917-3f65e02366b42026-06-08WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLTOPCO ASSOCIATES LLC9558cc42-d27d-42af-b0a7-44cad025165d2026-05-21WarningsExact identifier
application number: M010
Sleep Aid NightTimeDIPHENHYDRAMINE HCLWal-Mart Stores Incdac2a0b9-f851-467b-a39f-3560d42c96e22026-05-20WarningsExact identifier
application number: M010
Sleep Aid NighttimeDIPHENHYDRAMINE HCLWalgreen Companyec3618dd-8713-4f3c-b639-fc240021c7be2026-05-13WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLRite Aid Corporationfbedb50d-b96f-4ce4-a1dc-d2b357cf6de12026-05-13WarningsExact identifier
application number: M010
Sleep Aid NighttimeDIPHENHYDRAMINE HCLFamily Dollar Services Inc8ebd9949-ef53-4d66-a20c-3e0047b3e1ef2026-05-13WarningsExact identifier
application number: M010
Sleep Aid NighttimeDIPHENHYDRAMINE HCLCVS Pharmacy0be4ef9a-2484-41dd-8bb8-e92d411f13842026-05-11WarningsExact identifier
application number: M010
Nighttime Sleep-AidDIPHENHYDRAMINE HCLAMERISOURCE BERGENca052b38-de38-7bf0-e053-2995a90a4e852026-05-11WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLStrategic Sourcing Services LLCe68d96c8-21c5-406c-b22c-3e384027c79f2026-05-07WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLKroger Companyb71bb567-5605-430b-b3fa-048fe9bbe8ff2026-05-04WarningsExact identifier
application number: M010
Sleep II Nighttime Sleep AidDIPHENHYDRAMINE HCLWalgreen Companyed864c84-a430-4ca8-87e8-04f1c1df538b2026-05-04WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLWalgreen Companyf8f17615-e4ec-49d4-9c0d-581d0fd6feb72026-04-28WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLL.N.K. International, Inc.888dc258-d5a3-4b62-aea1-c81ea29ff6f52026-04-28WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLAmerisource Bergen8f1cb631-4633-4ef5-868e-48a46ab311a42026-04-27WarningsExact identifier
application number: M010
VICKS ZzzQuil NIGHTTIME SLEEP-AIDDIPHENHYDRAMINE HCLThe Procter & Gamble Manufacturing Company05f77c69-c8ea-f8ba-e063-6394a90aa60f2026-04-23WarningsExact identifier
application number: M010
Vicks ZzzQuil Night PainDIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHENThe Procter & Gamble Manufacturing Companyf3bb75e8-3d43-f91e-e053-2a95a90a584d2026-04-23WarningsExact identifier
application number: M010
ndc (product): 69423-985
Nightime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEBETTER LIVING BRANDS LLC.202bb1ff-3273-4872-e063-6294a90abebb2026-04-11WarningsExact identifier
application number: M010
Vicks ZzzQuil Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company1be2f00b-5bdd-82e7-e063-6394a90ab9a52026-04-06WarningsExact identifier
application number: M010
Night Time Sleep AidDIPHENHYDRAMINE HCLHyVee Inccf94fa56-01a5-4d6c-ad08-38b0ea3633992026-04-03WarningsExact identifier
application number: M010
Sleep-AidDIPHENHYDRAMINE HCLARMY AND AIR FORCE EXCHANGE SERVICE84ec323d-0523-41e8-856c-e02d6afdc9ec2026-04-02WarningsExact 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