Family Wellness 44-367

Manufacturer
Family Dollar Services Inc | LNK International, Inc.
Effective date
2026-05-13
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 01:57:12

Label at a glance#

ProductSleep Aid Nighttime
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 adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor children under 12 years: do not use

Storage and handling

each caplet contains: calcium 30 mg TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN protect from moisture store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number

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

  • 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
  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma

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
  • adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor
  • children under 12 years: do not use

Other information

STORAGE AND HANDLING SECTION

  • each caplet contains: calcium 30 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • protect from moisture
  • 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

corn starch, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FAMILY
wellness™

*COMPARE TO THE
ACTIVE INGREDIENT
IN SIMPLY SLEEP®

SLEEP AID
Diphenhydramine HCl 25 mg
Nighttime Sleep-Aid

Safe & Effective
Helps You Fall Asleep
Not for treating Pain, Cold or Flu

24 CAPLETS

ACTUAL SIZE

NDC 55319-367-08

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Kenvue
Inc., owner of the registered trademark Simply Sleep®.
50844    ORG101936712

DISTRIBUTED BY: MIDWOOD BRANDS LLC,
500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA
NOT 100% SATISFIED?
Return within 30 days to the store of purchase
for a refund (with receipt) or exchange.

Family Wellness 44-367
Family Wellness 44-367

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN12
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD12

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
55319-367-08Sleep AidNighttime2 in 1 CARTONTABLET, FILM COATED212
55319-367-08Sleep AidNighttime12 in 1 BLISTER PACKTABLET, FILM COATED1212
55319-367-12Sleep AidNighttime100 in 1 BOTTLETABLET, FILM COATED10012
55319-367-12Sleep AidNighttime1 in 1 CARTONTABLET, FILM COATED112

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD405
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83M5
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92J5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I305
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A5
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J9905
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU45
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP5
TALCINACTIVE INGREDIENT7SEV7J4R1U5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP5

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
55319-36755319-367-08, 55319-367-12

Ingredients#

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

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

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 30 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990TABLET, FILM COATED / ORAL20 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, FILM COATED / ORAL91 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, FILM COATED / ORAL91 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET, FILM COATED / ORAL1075 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET, FILM COATED / ORAL1075 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, FILM COATED / ORAL91 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990TABLET, FILM COATED / ORAL20 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET, FILM COATED / ORAL1075 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990TABLET, FILM COATED / ORAL20 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates

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 NighttimeDIPHENHYDRAMINE HCLFamily Dollar Services Inc8ebd9949-ef53-4d66-a20c-3e0047b3e1ef2026-05-13WarningsExact identifier
ndc (package): 55319-367-12
ndc (package): 55319-367-08
ndc (product): 55319-367
ndc11 (package): 55319036708
ndc11 (package): 55319036712
spl id: ca5419cb-5e17-48ed-97ab-7b48dab5482f
spl set id: 8ebd9949-ef53-4d66-a20c-3e0047b3e1ef

Reported adverse events (FAERS/openFDA)#

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