FDA.reportPublic FDA data

ZzzQuil

Product NDC
84126-316
11-digit product format
841260316
Labeler code
84126
Product ID
84126-316_4c48a499-96b2-2775-e063-6394a90ad205
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
LIQUID
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-15
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ZzzQuil
Brand name suffix
Nighttime Sleep-Aid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1248354, 1248356

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-316-04ZzzQuilNighttime Sleep-Aid118 mL in 1 BOTTLE, PLASTICLIQUID1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84126-316ZZZQUIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1Current NDC, 1 package rows20240717_1d608c94-1651-f318-e063-6294a90aa11e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSN1d608c94-1651-f318-e063-6294a90aa11e3
1248356ZzzQuil NIGHTTIME SLEEP-AID 50 MG in 30 mL Oral SolutionPSN1d608c94-1651-f318-e063-6294a90aa11e3
1248356diphenhydramine hydrochloride 1.67 MG/ML Oral Solution [Zzzquil]SBD1d608c94-1651-f318-e063-6294a90aa11e3
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCD1d608c94-1651-f318-e063-6294a90aa11e3
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSY1d608c94-1651-f318-e063-6294a90aa11e3
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSY1d608c94-1651-f318-e063-6294a90aa11e3
1248356Zzzquil 1.67 MG/ML Oral SolutionSY1d608c94-1651-f318-e063-6294a90aa11e3
1248356Zzzquil 50 MG per 30 ML Oral SolutionSY1d608c94-1651-f318-e063-6294a90aa11e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-316-0484126031604118 mL in 1 BOTTLE, PLASTIC (84126-316-04) 118 ml2024-06-15NoNoCurrent