FDA.reportPublic FDA data

Walgreens 44-799

Manufacturer
Walgreen Company | LNK International, Inc.
Effective date
2026-08-24
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-08-26 01:01:46

Label at a glance#

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

Storage and handling

each caplet contains: calcium 50 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 50 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

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

Other information

STORAGE AND HANDLING SECTION

  • each caplet contains: calcium 50 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

croscarmellose sodium, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Walgreens

• WALGREENS •
PHARMACIST RECOMMENDED †

Compare to the active ingredient in
Benadryl® Allergy Extra Strength††

EXTRA STRENGTH
Allergy Relief

DIPHENHYDRAMINE HCl CAPLETS, 50 mg / ANTIHISTAMINE

Dye-Free
Extra Strength

• Sneezing; itchy, watery eyes;
  runny nose & itchy throat
• Ages 12 years & older

24 CAPLETS

ACTUAL SIZE

Walgreens 44-799 REV0225A
Walgreens 44-799 REV0225A

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130311917063263GTIN-13: 0311917063263
EAN-13: 0311917063263
GTIN-12: 311917063263
UPC-A: 311917063263
GTIN storage (14 digits): 00311917063263		walgreens-44-799-1.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

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-17990363-1799-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42026-06-30weekly-update2026-07-17 21:41:53
32025-06-02full-release2026-06-01 01:02:07

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 ReliefDIPHENHYDRAMINE HCLWalgreen Company7d972559-6184-476b-9cbf-1bc5663ea00d2026-08-24WarningsExact identifier
ndc (package): 0363-1799-08
ndc (product): 0363-1799
ndc11 (package): 00363179908
spl id: 902c45b7-18fe-45b5-bf40-e534041f2a7b
spl set id: 7d972559-6184-476b-9cbf-1bc5663ea00d

Reported adverse events (FAERS/openFDA)#

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