FDA.reportPublic FDA data

ZzzQuil

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2024-10-10
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 00:24:17

Label at a glance#

ProductZzzQuil Nighttime Sleep-Aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep

Dosage and administration

take only one dose (30 mL) per day (24 hours) only use dose cup provided adults & children 12 yrs & over 30 mL at bed time if needed or as directed by a doctor children under 12 yrs do not use

Storage and handling

each 30 mL dose contains: sodium 23 mg store at no greater than 25ºC

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 30 mL dose cup)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 50 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

  • for the relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • avoid alcoholic beverages

Stop use and ask a doctor if

OTC - STOP USE SECTION

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

SPL UNCLASSIFIED SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only one dose (30 mL) per day (24 hours)
  • only use dose cup provided
adults & children 12 yrs & over30 mL at bed time if needed or as directed by a doctor
children under 12 yrsdo not use

Other information

STORAGE AND HANDLING SECTION

  • each 30 mL dose contains:sodium 23 mg
  • store at no greater than 25ºC

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol, citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, polysorbate 20, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose, water, xanthan gum

Questions?

OTC - QUESTIONS SECTION

1-877-881-5813

SPL UNCLASSIFIED SECTION

Tamper evident:do not use if printed shrinkband seal around the neck is broken or missing

SPL UNCLASSIFIED SECTION

MADE IN CANADA

DIST. BY

PROCTER & GAMBLE, CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VICKS ®

ZzzQuil™

NIGHTTIME SLEEP-AID

Diphenhydramine HCl

Fall Asleep Fast
Non-Habit Forming


Alcohol 10%

4 FL OZ (118 mL)

4oz4oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSN10
1248356ZzzQuil NIGHTTIME SLEEP-AID 50 MG in 30 mL Oral SolutionPSN10
1248356diphenhydramine hydrochloride 1.67 MG/ML Oral Solution [Zzzquil]SBD10
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCD10
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSY10
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSY10
1248356Zzzquil 1.67 MG/ML Oral SolutionSY10
1248356Zzzquil 50 MG per 30 ML Oral SolutionSY10

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-97969423-979-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
FD&C RED NO. 40WZB9127XOAIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
SUCRALOSE96K6UQ3ZD4IACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
SODIUM CITRATE1Q73Q2JULRIACT
XANTHAN GUMTTV12P4NEEIACT
POLYSORBATE 207T1F30V5YHIACT
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ALCOHOL3K9958V90MIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
24231292-7b80-0d7e-e063-6294a90a925ddd1ab38a-afe6-07ea-e053-2995a90ad98f2024-10-10WarningsExact identifier
spl id: 24231292-7b80-0d7e-e063-6294a90a925d
spl set id: dd1ab38a-afe6-07ea-e053-2995a90ad98f

Reported adverse events (FAERS/openFDA)#

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