FDA.reportPublic FDA data

160R Walgreens 0363 0100 Diphenhydramine Hydrochloride 25 mg tablets

Manufacturer
WALGREENS | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date
2025-06-25
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:03:58

Label at a glance#

ProductALLERGY RELIEF
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

OTC - PURPOSE SECTION

Purpose

Antihistamine

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • glaucoma
  • trouble urinating due to enlarged prostrate gland
  • a breathing problem such as emphysema or chronic bronchitis

OTC - DO NOT USE SECTION

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

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

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

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. (1-800-222-1222)

DOSAGE & ADMINISTRATION SECTION

Directions

  • 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 of age and over: 1 to 2 caplets

children 6 to under 12 years of age: 1 caplet

children under 6 years of age: do not use

OTHER SAFETY INFORMATION

Other information

  • each caplet contains: calcium 25 mg
  • protect from light
  • Store between 20-25°C (68-77° F)
  • use by expiration date on package

INACTIVE INGREDIENT SECTION

Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80, titanium dioxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

160R-walg-600ct160R-walg-600ct

160R-walg-365ct160R-walg-365ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN4
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD4

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-0100-612025-02-11C16284748780-12cef2736-5cb6-d83d-e063-dadaa90ab31f160R Walgreens 0363 0100 Diphenhydramine Hydrochloride 25 mg tablets
0363-0100-652025-02-11C16284748780-12cef2736-5cb6-d83d-e063-dadaa90ab31f160R Walgreens 0363 0100 Diphenhydramine Hydrochloride 25 mg tablets
0363-0100-612025-01-30C16284748780-12cef2736-5cb6-d83d-e063-dadaa90ab31f160R Walgreens 0363 0100 Diphenhydramine Hydrochloride 25 mg tablets
0363-0100-652025-01-30C16284748780-12cef2736-5cb6-d83d-e063-dadaa90ab31f160R Walgreens 0363 0100 Diphenhydramine Hydrochloride 25 mg tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0100-61ALLERGY RELIEF600 in 1 BOTTLETABLET, FILM COATED6004
0363-0100-65ALLERGY RELIEF365 in 1 BOTTLETABLET, FILM COATED3654

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-01000363-0100-65, 0363-0100-61

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
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
CARNAUBA WAXR12CBM0EIZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM STEARATE70097M6I30IACT
POLYSORBATE 806OZP39ZG8HIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
HYPROMELLOSES3NXW29V3WOIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
POLYETHYLENE GLYCOL 400B697894SGQIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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
ALLERGY RELIEFDIPHENHYDRAMINE HYDROCHLORIDEWALGREENSc0270298-e7c5-e500-e053-2995a90aed232025-06-25WarningsExact identifier
ndc (package): 0363-0100-65
ndc (package): 0363-0100-61
ndc (product): 0363-0100
ndc11 (package): 00363010065
ndc11 (package): 00363010061
spl id: 385fdd93-c3a3-d252-e063-6394a90ab2ac
spl set id: c0270298-e7c5-e500-e053-2995a90aed23

Reported adverse events (FAERS/openFDA)#

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