FDA.reportPublic FDA data

Vicks

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-10-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-10-06 02:02:45

Label at a glance#

ProductVICKS ZzzQuil FREE and CLEAR 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 dose cup contains:  sodium 88 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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • 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 a serious underlying medical illness.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 dose cup contains: sodium 88 mg
  • store at no greater than 25°C

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, glycerin, natural flavor, polysorbate 20, propylene glycol, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, water

Questions or comments?

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Vicks®

ZzzQuil™

FREE & CLEAR

NIGHTTIME SLEEP-AID

Diphenhydramine HCl

FREE OF

DYES · SUGAR · ALCOHOL · CORN SYRUP

Fall Asleep Fast

Non-Habit Forming

Strawberry Flavored

Not for colds or for pain

12 FL OZ (354 mL)

370370

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130323900038561GTIN-13: 0323900038561
EAN-13: 0323900038561
GTIN-12: 323900038561
UPC-A: 323900038561
GTIN storage (14 digits): 00323900038561		370.jpg
QR code linkQR Codescan.pg.com/01/00323900038561370.jpg
Data codeData Matrix21434114370.jpg
Data codeData Matrix21434115370.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84126-37084126-370-12, 84126-370-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM BENZOATEOJ245FE5EUIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
POLYSORBATE 207T1F30V5YHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-12-22full-release2026-06-01 01:36:09

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
VICKS ZzzQuil FREE and CLEAR NIGHTTIME SLEEP-AIDDIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company468fa756-1ed6-4652-e063-6294a90a67ea2025-12-22WarningsExact identifier
ndc (package): 84126-370-12
ndc (package): 84126-370-24
ndc (product): 84126-370
ndc11 (package): 84126037024
ndc11 (package): 84126037012
spl set id: 468fa756-1ed6-4652-e063-6294a90a67ea

Reported adverse events (FAERS/openFDA)#

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