FDA.reportPublic FDA data

ZzzQuil

Product NDC
69423-979
Requested package NDC
69423-979-04
11-digit product format
694230979
Labeler code
69423
Product ID
69423-979_ded3bf7b-1a9e-0e3b-e053-2a95a90a7471
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
LIQUID
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
part338
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-05-12
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/30mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69423-97969423-979-04DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
69423-979-04ZzzQuilNighttime Sleep-Aid118 mL in 1 BOTTLE, PLASTICLIQUID11810

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-979ZZZQUIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [THE PROCTER & GAMBLE MANUFACTURING COMPANY]10Legacy NDC, 1 package rows20241012_dd1ab38a-afe6-07ea-e053-2995a90ad98f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSNdd1ab38a-afe6-07ea-e053-2995a90ad98f10
1248356ZzzQuil NIGHTTIME SLEEP-AID 50 MG in 30 mL Oral SolutionPSNdd1ab38a-afe6-07ea-e053-2995a90ad98f10
1248356diphenhydramine hydrochloride 1.67 MG/ML Oral Solution [Zzzquil]SBDdd1ab38a-afe6-07ea-e053-2995a90ad98f10
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCDdd1ab38a-afe6-07ea-e053-2995a90ad98f10
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSYdd1ab38a-afe6-07ea-e053-2995a90ad98f10
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSYdd1ab38a-afe6-07ea-e053-2995a90ad98f10
1248356Zzzquil 1.67 MG/ML Oral SolutionSYdd1ab38a-afe6-07ea-e053-2995a90ad98f10
1248356Zzzquil 50 MG per 30 ML Oral SolutionSYdd1ab38a-afe6-07ea-e053-2995a90ad98f10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69423-979-0469423097904118 mL in 1 BOTTLE, PLASTIC (69423-979-04) 118 ml2022-05-120000-00-00NoNoCurrent