FDA.reportPublic FDA data

Diphenhydramine HCl 50 mg tablet, Dollar General, allergy relief

Manufacturer
DOLGENCORP INC | Bionpharma Inc. | OrBion Pharmaceuticals Private Limited | JOHNSON & SMITH COMPANY
Effective date
2026-07-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-08-01 05:10:12

Label at a glance#

ProductAllergy Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

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

Dosage and administration

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

Storage and handling

■ each tablet contains: calcium 36 mg ■ store between 20-25°C (68-77°F). Protect from light. ■ do not use if blister unit is torn or broken

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

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 the other upper respiratory allergies:
■ runny nose ■ sneezing ■ itchy, watery eyes ■ itching of the nose or throat

Warnings

WARNINGS SECTION

■ May cause excitability especially in children.

■ May cause marked drowsiness; alcohol, sedatives, and tranquilizres may increase the drowsiness effect.

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

■ 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

OTC - ASK DOCTOR/PHARMACIST SECTION

if you are taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

■ avoid alcoholic beverages ■ be careful 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

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 Centre right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and over

■ take 1 tablet every 4 to 6 hours, or as directed by a doctor

■ do not take more than 6 tablets in 24 hours

children under 12 yearsdo not use

Other information

STORAGE AND HANDLING SECTION

■ each tablet contains: calcium 36 mg ■ store between 20-25°C (68-77°F). Protect from light.

■ do not use if blister unit is torn or broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free 1-888-235-2466(Mon - Fri 9AM - 5PM EST)

SPL UNCLASSIFIED SECTION

†This product is not manufactured or distributed by the owners of Benadryl® Allergy Extra Strength.

THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND

TAMPER-EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE

WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE GOODLETTSVILLE, TN 37072

MADE IN INDIA

L0001282

R0426

carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

†Compare to the

active ingredient of
Benadryl® Allergy

Extra Strength

DG TMhealth

Extra Strength

Allergy Relief

diphenhydramine HCl Tablets, 50 mg
Antihistamine

Relieves:
• Sneezing • Itchy throat or nose
• Runny nose • Itchy, watery eyes

50

mg each

24 Tablets

cartoncarton

carton-2carton-2

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 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55910-45055910-450-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
TITANIUM DIOXIDE15FIX9V2JPIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
TALC7SEV7J4R1UIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-06-23full-release2026-06-01 01:03:44

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 HCLDOLGENCORP INC38400854-27fa-e291-e063-6294a90a5c4e2026-07-27WarningsExact identifier
ndc (package): 55910-450-12
ndc (product): 55910-450
ndc11 (package): 55910045012
spl id: 57c0df1b-bb9c-1913-e063-6394a90a8427
spl set id: 38400854-27fa-e291-e063-6294a90a5c4e

Reported adverse events (FAERS/openFDA)#

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