FDA.reportPublic FDA data

Sleep Aid

Manufacturer
Ulai Health LLC
Effective date
2022-01-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:47:52

Label at a glance#

ProductSleep Aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

helps reduce difficulty falling asleep

Dosage and administration

 adults and children 12 years and over  take 2 caplets at bedtime if needed, or as directed by your doctor

Storage and handling

each caplet contains: calcium 15 mg store at 20-25 o C (68-77 o F)

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep aid

Uses

INDICATIONS & USAGE SECTION

  • helps reduce difficulty falling asleep

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged 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 drinks
  • use caution when driving a motor vehicle or operating machinery

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.

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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

 adults and children 12 years and over take 2 caplets at bedtime if needed, or as directed by your doctor

Other information

STORAGE AND HANDLING SECTION

  • each caplet contains: calcium 15 mg
  • store at 20-25 oC (68-77 oF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, corn startch, FD&C blue #1, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PHARBEST

NDC 73057-358-06

Manufactured in the USA

Safe, Non-habit forming

Sleep Aid

*Compare to the active ingredient in Sominex ® 

Diphenhydramine HCl 25 mg

Nighttime Sleep Aid

50 CAPLETS

Ulai SleepAid Caplet 50 ct. LabelUlai SleepAid Caplet 50 ct. Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN2
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD2

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73057-358-062025-01-30C16284748780-1d6a99b39-3620-a426-e053-dadaa90af4c2Drug Facts
73057-358-062022-01-31C16284748780-1d6a99b39-3620-a426-e053-dadaa90af4c2Drug Facts
73057-358-062022-01-28C16284748780-1d6a99b39-3620-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73057-358-06Sleep Aid50 in 1 BOTTLE, PLASTICTABLET502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73057-358SLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET [ULAI HEALTH LLC]2Legacy NDC, 1 package rows20220201_be1d7d73-7c6a-4826-8493-437e2bb7d11e.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73057-35873057-358-06

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
SILICON DIOXIDEETJ7Z6XBU4IACT
STARCH, CORNO8232NY3SJIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSL11K75P92JIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d6e6ff9c-dd59-7544-e053-2995a90ac6f4be1d7d73-7c6a-4826-8493-437e2bb7d11e2022-01-31WarningsExact identifier
spl id: d6e6ff9c-dd59-7544-e053-2995a90ac6f4
spl set id: be1d7d73-7c6a-4826-8493-437e2bb7d11e

Reported adverse events (FAERS/openFDA)#

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