FDA.reportPublic FDA data

Kirkland 44-329

Manufacturer
COSTCO WHOLESALE CORPORATION | LNK International, Inc.
Effective date
2026-05-29
Label type
HUMAN OTC DRUG LABEL
Version
21
Source
daily-update
Hydrated at
2026-06-03 18:03:25

Label at a glance#

ProductAllergy Medicine
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat temporarily relieves these symptoms due to the common cold: runny nose sneezing

Dosage and administration

do not take more than directed take every 4 to 6 hours, or as directed by a doctor do not take more than 6 times in 24 hours adults and children 12 years and over 1 to 2 tablets children 6 to under 12 years 1 tablet children under 6 years do not use

Storage and handling

each tablet contains: calcium 30 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) protect from moisture use by expiration date on package

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • itchy, watery eyes
    • sneezing
    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • to make a child sleepy
  • 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

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery

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
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times in 24 hours
adults and children 12 years and over1 to 2 tablets
children 6 to under 12 years1 tablet
children under 6 yearsdo not use

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 30 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from moisture
  • use by expiration date on package

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, 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

KIRKLAND
Signature

COMPARE TO BENADRYL®
ALLERGY ULTRATABS®
active ingredient*

NDC 63981-329-78
ITM. / ART. 536099

ALLERGY
MEDICINE

Diphenhydramine HCl 25 mg

Antihistamine • Allergy Relief

For Temporary Relief of:
Sneezing & Runny Nose
Itchy, Watery Eyes
Hay Fever Symptoms
Itching of Nose or Throat

Actual Size

600
Minitabs

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not
manufactured or distributed by
Kenvue Inc., owner of the
registered trademark Benadryl®
Allergy ULTRATABS®.
50844  REV0625L32978

Manufactured by: LNK INTERNATIONAL, INC.
Hauppauge, NY 11788 USA
For: Costco Wholesale Corporation, P.O. Box 34535
Seattle, WA 98124-1535 USA       1-800-774-2678      www.costco.com

Kirkland 44-329
Kirkland 44-329

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN21
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD21

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-130096619536092GTIN-13: 0096619536092
EAN-13: 0096619536092
GTIN-12: 096619536092
UPC-A: 096619536092
GTIN storage (14 digits): 00096619536092		kirkland-44-329-1.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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63981-329-78EA - Each63981-32998a66b0e-bb3c-4397-a127-3a41b7bd043412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD405
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83M5
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92J5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U5
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6K5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I305
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A5
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J9905
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU45
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP5
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
63981-32963981-329-78

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
STARCH, CORNO8232NY3SJIACT
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
202026-04-09full-release2026-06-01 01:54:31

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 · 22 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
D&C RED NO. 27D&C RED NO. 272LRS185U6KTABLET, CHEWABLE / ORAL7 mgExact identifier — unii+route
8 equally ranked IID candidates
D&C RED NO. 27D&C RED NO. 272LRS185U6KTABLET / ORAL1 mgExact identifier — unii+route
8 equally ranked IID candidates
D&C RED NO. 27D&C RED NO. 272LRS185U6KPOWDER, FOR SUSPENSION / ORAL1.67 mg/5mlExact identifier — unii+route
8 equally ranked IID candidates
D&C RED NO. 27D&C RED NO. 272LRS185U6KPOWDER, FOR SUSPENSION / ORAL1.67 mg/5mlExact identifier — unii+route
8 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990TABLET, FILM COATED / ORAL20 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
D&C RED NO. 27D&C RED NO. 272LRS185U6KTABLET, CHEWABLE / ORAL7 mgExact identifier — unii+route
8 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET, FILM COATED / ORAL1075 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
D&C RED NO. 27D&C RED NO. 272LRS185U6KTABLET, EXTENDED RELEASE / ORAL1.43 mgExact identifier — unii+route
8 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990TABLET, FILM COATED / ORAL20 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET, FILM COATED / ORAL1075 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
D&C RED NO. 27D&C RED NO. 272LRS185U6KTABLET / ORAL1 mgExact identifier — unii+route
8 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
D&C RED NO. 27D&C RED NO. 272LRS185U6KTABLET, EXTENDED RELEASE / ORAL1.43 mgExact identifier — unii+route
8 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
2 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
Allergy MedicineDIPHENHYDRAMINE HCLCOSTCO WHOLESALE CORPORATIONd9f03e11-d11f-43ee-8ed0-9e07d1058f662026-05-29WarningsExact identifier
ndc (package): 63981-329-78
ndc (product): 63981-329
ndc11 (package): 63981032978
spl id: 87e7d8ca-ee63-4f68-ae33-aafb9c670b2e
spl set id: d9f03e11-d11f-43ee-8ed0-9e07d1058f66

Reported adverse events (FAERS/openFDA)#

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