FDA.reportPublic FDA data

Sleep Aid

Manufacturer
Wal-Mart Stores Inc | LNK International, Inc.
Effective date
2026-03-05
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:49:09

Label at a glance#

ProductSleep Aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

do not take more than directed mL = milliliter only use the dose cup provided take only one dose per day (24 hours) adults and children 12 years and over: 30 mL at bedtime if needed or as directed by a doctor children under 12 years: do not use

Storage and handling

each 30 mL contains: sodium 21 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package

Label contents#

Full prescribing information#

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 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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • mL = milliliter
  • only use the dose cup provided
  • take only one dose per day (24 hours)
  • adults and children 12 years and over: 30 mL at bedtime if needed or as directed by a doctor
  • children under 12 years: do not use

Other information

STORAGE AND HANDLING SECTION

  • each 30 mL contains: sodium 21 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, high fructose corn syrup, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, sucrose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

1-888-287-1915

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 49035-704-02

equate™

Compare to
VICKS® ZzzQuil®
Nighttime
Sleep-Aid
active
ingredient*

Nighttime
Sleep-Aid

Diphenhydramine HCl
50 mg per 30 mL
Nighttime Sleep-Aid

• Non-habit forming
• Not for colds or
  for pain
• Ages 12+

12 FL OZ (355 mL)

Cherry
Vanilla

F-047
ORG

TAMPER EVIDENT: DO NOT USE IF PRINTED
NECK WRAP IS BROKEN OR MISSING

DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716
PRODUCT OF CHINA
*This product is not manufactured or distributed by The
Procter & Gamble Company, owner of the registered
trademark VICKS® ZzzQuil® Nighttime Sleep-Aid.

50844
ORG052304702

B-047 ORG

Satisfaction guaranteed - Or we’ll replace it or
give you your money back. For questions or
comments or to report an undesired reaction
or side effect, please call 1-888-287-1915.

Equate 44-047
Equate 44-047

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSN10
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

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-130681131280419GTIN-13: 0681131280419
EAN-13: 0681131280419
GTIN-12: 681131280419
UPC-A: 681131280419
GTIN storage (14 digits): 00681131280419		equate-44-047-1.jpg

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
49035-704-02Sleep Aid355 mL in 1 BOTTLE, PLASTICSOLUTION35510

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49035-70449035-704-02

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
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CHLORIDE451W47IQ8XIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
SUCRALOSE96K6UQ3ZD4IACT
SUCROSEC151H8M554IACT
XANTHAN GUMTTV12P4NEEIACT

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
Sleep AidDIPHENHYDRAMINE HCLWal-Mart Stores Inc5ef35ab9-b6e8-4c88-a623-35ac9d6bd3592026-03-05WarningsExact identifier
ndc (package): 49035-704-02
ndc (product): 49035-704
ndc11 (package): 49035070402
spl id: 9996fe9a-d6fe-4fb1-a5f3-fec1caeda1ff
spl set id: 5ef35ab9-b6e8-4c88-a623-35ac9d6bd359

Reported adverse events (FAERS/openFDA)#

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