FDA.reportPublic FDA data

Vicks ZzzQuil Nighttime Sleep-Aid

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-04-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:52:42

Label at a glance#

ProductVicks ZzzQuil Nighttime Sleep-Aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure19 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 bedtime if needed or as directed by a doctor children under 12 yrs do not use

Storage and handling

each 30 mL contains:  sodium 23 mg store at no greater than 25°C

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 30 mL)

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 are taking 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.

OVERDOSAGE 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 bedtime if needed or as directed by a doctor
children under 12 yrsdo not use

Other information

STORAGE AND HANDLING SECTION

  • each 30 mL contains: sodium 23 mg
  • store at no greater than 25°C

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 IS BROKEN OR MISSING.

SPL UNCLASSIFIED SECTION

DIST. BY PROCTER & GAMBLE,

CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 2 BOTTLES - 12 FL OZ (354 mL) EACH; TOTAL 24 FL OZ (708 mL); 2 CLEAR NASAL STRIPS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VICKS ®

ZzzQuil™

NIGHTTIME SLEEP-AID

Diphenhydramine HCl

Fall Asleep Fast

Non-Habit Forming

Warming Berry

Alcohol 10%

Not for colds or for pain

FREE SLEEP NASAL STRIPS INSIDE

2 BOTTLES - 12 FL OZ (354 mL) EACH; TOTAL 24 FL OZ (708 mL); 2 CLEAR NASAL STRIPS

306306

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSN3
1248356ZzzQuil NIGHTTIME SLEEP-AID 50 MG in 30 mL Oral SolutionPSN3
1248356diphenhydramine hydrochloride 1.67 MG/ML Oral Solution [Zzzquil]SBD3
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCD3
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSY3
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSY3
1248356Zzzquil 1.67 MG/ML Oral SolutionSY3
1248356Zzzquil 50 MG per 30 ML Oral SolutionSY3

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130323900036659GTIN-13: 0323900036659
EAN-13: 0323900036659
GTIN-12: 323900036659
UPC-A: 323900036659
GTIN storage (14 digits): 00323900036659		306.jpg
Data codeData Matrix21178468306.jpg

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
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
37000-500-12Vicks ZzzQuilNighttime Sleep-Aid354 mL in 1 BOTTLE, PLASTICLIQUID354 mL50 mg in 30mL3
37000-500-24Vicks ZzzQuilNighttime Sleep-Aid2 in 1 PACKAGE, COMBINATIONLIQUID50 mg in 30mL3
84126-306-03Vicks ZzzQuilNighttime Sleep-Aid1 in 1 CARTONKIT13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37000-500-06ML - Milliliter37000-5007c7ff596-24c8-4894-a0c7-9df5bfc3aec612013-03-03
37000-500-12ML - Milliliter37000-500e0b24d7c-6a0a-4407-a48b-cca3d0d3b8a112016-06-14
37000-500-24ML - Milliliter37000-5008581da31-ba83-4caa-828e-148ce4cb05a912017-06-15
37000-500-36ML - Milliliter37000-50048fae6c1-97bf-4d14-aac0-8989228fd3d812017-06-15

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84126-30684126-306-03
37000-50037000-500-12, 37000-500-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 207T1F30V5YHIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
ALCOHOL3K9958V90MIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vicks ZzzQuil Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company1be2f00b-5bdd-82e7-e063-6394a90ab9a52026-04-06WarningsExact identifier
ndc (package): 84126-306-03
ndc (package): 37000-500-12
ndc (package): 37000-500-24
ndc (product): 84126-306
ndc11 (package): 84126030603
ndc11 (package): 37000050012
ndc11 (package): 37000050024
spl id: 4ecd7f52-57c2-a89d-e063-6294a90ac7b1
spl set id: 1be2f00b-5bdd-82e7-e063-6394a90ab9a5
ZzzQuil Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companye441c952-cd48-4159-ada2-271ca75416002026-02-20WarningsExact identifier
ndc (package): 37000-500-12
ndc (package): 37000-500-24
ndc (product): 37000-500
ndc11 (package): 37000050012
ndc11 (package): 37000050024

Reported adverse events (FAERS/openFDA)#

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