FDA.reportPublic FDA data

Diphenhydramine HCl

Manufacturer
AARNA USA INC. | KJD PHARMA PRIVATE LIMITED
Effective date
2025-05-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:01:59

Label at a glance#

ProductDiphenhydramine HCl
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 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

Dosage and administration

take every 4 to 6 hours  do not take more than 6 doses in 24 hours 25 mg Dosage: Age Dose adults and children 12 years and over 1 to 2 capsules children 6 to under 12 years of age 1 capsule children under 6 years of age do not use this product in children under 6 years of age 50 mg Dosage:  Age  Dose  adults and children 12 years and over  1 capsules  children under 12 years of age  ask a doctor, the proper dosage...

Storage and handling

store at room temperature 20 º-25 ºC(68 º-77 ºF) do not use if either capsule band or imprinted safety seal under cap is broken or missing protect from moisture

Label contents#

Full prescribing information#

Active ingredient (in each banded capsule)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine Hydrochloride 25 mg and 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
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

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

  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

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 beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
  • be careful 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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take every 4 to 6 hours 
  • do not take more than 6 doses in 24 hours

25 mg Dosage:

AgeDose
adults and children 12 years and over1 to 2 capsules
children 6 to under 12 years of age1 capsule
children under 6 years of agedo not use this product in children under 6 years of age

50 mg Dosage:

 Age Dose
 adults and children 12 years and over 1 capsules
 children under 12 years of age ask a doctor, the proper dosage
strength is not available in this
package**

**Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the
25 mg. package.

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature 20 º-25 ºC(68 º-77 ºF)
  • do not use if either capsule band or imprinted safety seal under cap is broken or missing
  • protect from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

Colloidal silicon dioxide, Gelatin, Lactose Monohydrate, Magnesium Stearate, Microcrystalline cellulose

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free 1-877-225-6999

Manufactured for:

AARNA USA INC

Leland, NC 28451

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11223344

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN4
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN4
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD4
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD4
1020477diphenhydramine HCl 50 MG Oral CapsuleSY4

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
82568-0004-1Diphenhydramine HCl100 in 1 BOTTLECAPSULE1004
82568-0004-2Diphenhydramine HCl1000 in 1 BOTTLECAPSULE10004
82568-0005-1Diphenhydramine HCl100 in 1 BOTTLECAPSULE1004
82568-0005-2Diphenhydramine HCl1000 in 1 BOTTLECAPSULE10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82568-0004-1EA - Each82568-0004bd61f210-3f49-41f8-9cb7-74bc7e179b8e12025-11-13
82568-0004-2EA - Each82568-000402e7d248-56ac-4020-8b7f-8aec09287b8012025-11-13
82568-0005-1EA - Each82568-0005afffdf14-4554-4c30-83ed-1a383374ba7412025-11-13
82568-0005-2EA - Each82568-0005e0cdc316-b2b6-47a2-9152-2127192c4efe12025-11-13

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82568-000482568-0004-1, 82568-0004-2
82568-000582568-0005-1, 82568-0005-2

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
SILICON DIOXIDEETJ7Z6XBU4IACT
GELATIN2G86QN327LIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
GELATIN2G86QN327LIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

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
Diphenhydramine HClDIPHENHYDRAMINE HCLAARNA USA INC.365bb414-8425-a900-e063-6394a90aa8872025-05-30WarningsExact identifier
ndc (package): 82568-0004-2
ndc (package): 82568-0005-1
ndc (package): 82568-0005-2
ndc (package): 82568-0004-1
ndc (product): 82568-0005
ndc (product): 82568-0004
ndc11 (package): 82568000501
ndc11 (package): 82568000402
ndc11 (package): 82568000401
ndc11 (package): 82568000502
spl id: 365baf41-5399-4fd7-e063-6294a90a81e1
spl set id: 365bb414-8425-a900-e063-6394a90aa887

Reported adverse events (FAERS/openFDA)#

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