FDA.reportPublic FDA data

Sleep-Aid, Circle K

Manufacturer
Lil' Drug Store Products, Inc.
Effective date
2023-12-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:04:27

Label at a glance#

ProductSleep-Aid, Lil Drug Store
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

Directions do not take more than directed adults and children 12 years and over: take 2 caplets (50 mg) at bedtime if needed, or as directed by a doctor children under 12 years: do not use

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Purpose

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

Uses

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

Warnings

WARNINGS SECTION

​Warnings

OTC - DO NOT USE SECTION

Do not use

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • 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.

OTC - WHEN USING SECTION

When using this product avoid alcoholic beverages.

OTC - STOP USE SECTION

Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks.
Insomnia may be a symptom of a 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. In case of overdose, get medical help or contact a Poison
Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not take more than directed
  • adults and children 12 years and over: take 2 caplets (50 mg) at bedtime if needed, or as directed by a doctor
  • children under 12 years: do not use

Other information

SPL UNCLASSIFIED SECTION

​Other information

  • each caplet contains: calcium 65 mg
  • avoid excessive heat (greater than 100°F) or humidity
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients

corn starch, D&C red #27 aluminum lake, dibasic calcium
phosphate dihydrate, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline
cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

Questions? Call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

PDP [Lil' Drug Store Nighttime Sleep-Aid, 24ct]

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

[caduceus]

*Compare to the Active Ingredient in
VICKS® ZzzQuil ®

Nighttime

Sleep-Aid
Diphenhydramine HCI 25 mg
Nighttime Sleep-Aid

[caplet image]

ACTUAL SIZE

  • Non-Habit Forming

​Not for treating Pain, Cold or Flu
24
Caplets [Lil' Drug Store logo]

PDPPDP

PDP [Circle K Nighttime Sleep-Aid, 24ct]

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NON-HABIT FORMING
NOT FOR TREATING PAIN, COLD OR FLU
Compare to the active ingredient in
Vicks® ZzzQuil ®*

CIRCLE K™

nighttime
sleep-aid
Diphenhydramine HCI, 25 mg
Nighttime Sleep-Aid

[caplet image]

actual size

24 caplets

PDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN3
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD3

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
66715-5503-8Sleep-Aid, Circle K2 in 1 CARTONTABLET, FILM COATED23
66715-5503-8Sleep-Aid, Circle K12 in 1 BLISTER PACKTABLET, FILM COATED123
66715-6643-8Sleep-Aid, Lil Drug Store12 in 1 BLISTER PACKTABLET, FILM COATED123
66715-6643-8Sleep-Aid, Lil Drug Store2 in 1 CARTONTABLET, FILM COATED23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-5503SLEEP-AID, LIL DRUG STORE (DIPHENHYDRAMINE HCL CAPLET, 25MG) TABLET, FILM COATED SLEEP-AID, CIRCLE K (DIPHENHYDRAMINE HCL CAPLET, 25MG) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]3Current NDC, Legacy NDC, 2 package rows20231215_d3ad24c4-44ba-6451-e053-2a95a90a1339.zip
66715-6643SLEEP-AID, LIL DRUG STORE (DIPHENHYDRAMINE HCL CAPLET, 25MG) TABLET, FILM COATED SLEEP-AID, CIRCLE K (DIPHENHYDRAMINE HCL CAPLET, 25MG) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]3Current NDC, Legacy NDC, 2 package rows20231215_d3ad24c4-44ba-6451-e053-2a95a90a1339.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
66715-664366715-6643-8
66715-550366715-5503-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C BLUE NO. 2--ALUMINUM LAKE4AQJ3LG584IACT
STARCH, CORNO8232NY3SJIACT
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
MAGNESIUM STEARATE70097M6I30IACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
STARCH, CORNO8232NY3SJIACT
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
FD&C BLUE NO. 2--ALUMINUM LAKE4AQJ3LG584IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
MAGNESIUM STEARATE70097M6I30IACT
SILICON DIOXIDEETJ7Z6XBU4IACT

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-Aid, Circle KDIPHENHYDRAMINE HCL CAPLET, 25MGLil' Drug Store Products, Inc.d3ad24c4-44ba-6451-e053-2a95a90a13392023-12-14WarningsExact identifier
ndc (package): 66715-5503-8
ndc (package): 66715-6643-8
ndc (product): 66715-5503
ndc (product): 66715-6643
ndc11 (package): 66715664308
ndc11 (package): 66715550308
spl id: 0c7ba1ad-f58d-aae5-e063-6294a90a1ed2
spl set id: d3ad24c4-44ba-6451-e053-2a95a90a1339

Reported adverse events (FAERS/openFDA)#

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