FDA.reportPublic FDA data

Diphenhydramine Hydrochloride Capsules, USP 25 mg Dye Free

Manufacturer
Walgreens
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:30:04

Label at a glance#

ProductAllergy Relief Dye Free
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure14 sections

Indications and uses

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

Dosage and administration

take every 4 to 6 hours do not take more than 6 doses in 24 hours adults and children 12 years of age and over 1 to 2 capsules children 6 to under 12 years of age 1 capsule children under 6 years do not use this product in children under 6 years of age

Storage and handling

store between 20° to 25°C (68° to 77°F). Avoid high humidity and excessive heat. Protect from light.

Label contents#

Full prescribing information#

Active Ingredient (in each liquid-filled capsules)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

Warnings Do not use

WARNINGS 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
  • trouble urinating due to an enlarged 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

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

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. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
adults and children 12 years of age and over1 to 2 capsules
children 6 to under 12 years of age1 capsule
children under 6 yearsdo not use this product in children under 6 years of age

Other Information

STORAGE AND HANDLING SECTION

  • store between 20° to 25°C (68° to 77°F). Avoid high humidity and excessive heat. Protect from light.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution.

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

diphen 25 mg dye freediphen 25 mg dye free

diphen 25 mg dye free 48countdiphen 25 mg dye free 48count

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN2
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD2

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
0363-6682-24Allergy ReliefDye Free2 in 1 CARTONCAPSULE, LIQUID FILLED22
0363-6682-24Allergy ReliefDye Free12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED122
0363-6682-48Allergy ReliefDye Free4 in 1 CARTONCAPSULE, LIQUID FILLED42
0363-6682-48Allergy ReliefDye Free12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED122

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-66820363-6682-24, 0363-6682-48

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 400B697894SGQIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT

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 Relief Dye FreeDIPHENHYDRAMINE HYDROCHLORIDE 25MGWalgreens36ba3ff2-1965-aa56-e063-6294a90afe172025-12-31WarningsExact identifier
ndc (package): 0363-6682-48
ndc (package): 0363-6682-24
ndc (product): 0363-6682
ndc11 (package): 00363668224
ndc11 (package): 00363668248
spl id: 474d5285-63ec-bf7c-e063-6294a90a72db
spl set id: 36ba3ff2-1965-aa56-e063-6294a90afe17

Reported adverse events (FAERS/openFDA)#

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