FDA.reportPublic FDA data

Vicks ZzzQuil

Product NDC
69423-985
11-digit product format
694230985
Labeler code
69423
Product ID
69423-985_50251f25-9af1-cc04-e063-6294a90a0da2
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
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
2027-12-31
Current FDA listing
Yes

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
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
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

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