FDA.reportPublic FDA data

Diphenhydramine HCl

Manufacturer
Akron Pharma Inc.
Effective date
2023-02-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:54:19

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 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

Storage and handling

store at temperature 15° to 30° C (59° to 86°F)  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

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
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

Other information

STORAGE AND HANDLING SECTION

  • store at temperature 15° to 30° C (59° to 86°F) 
  • 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, croscarmellose sodium, hard gelatin capsules, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline
cellulose, propyl paraben sodium.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free 1-877-225-6999
Mfg Lic .No: TN/DRUGS/558/1997

Manufactured for:
Akron Pharma, Inc,

373 RT US 46 W, Building E,

Suite 117, Fairfield, NJ 07004

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

25mg25mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN3
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD3

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
71399-8028-12025-01-30C16284748780-1f386c649-a338-0266-e053-dadaa90a7c1aAkron Pharma, Inc.
71399-8028-22025-01-30C16284748780-1f386c649-a338-0266-e053-dadaa90a7c1aAkron Pharma, Inc.
71399-8028-12023-02-28C16284748780-1f386c649-a338-0266-e053-dadaa90a7c1aAkron Pharma, Inc.
71399-8028-22023-02-28C16284748780-1f386c649-a338-0266-e053-dadaa90a7c1aAkron Pharma, Inc.
71399-8028-12023-01-30C16284748780-1f386c649-a338-0266-e053-dadaa90a7c1aAkron Pharma, Inc.
71399-8028-22023-01-30C16284748780-1f386c649-a338-0266-e053-dadaa90a7c1aAkron Pharma, Inc.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-8028-1Diphenhydramine HCl100 in 1 BOTTLECAPSULE1003
71399-8028-2Diphenhydramine HCl1000 in 1 BOTTLECAPSULE10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-8028DIPHENHYDRAMINE HCL CAPSULE [AKRON PHARMA INC.]3Legacy NDC, 2 package rows20230302_0617dd75-2e5a-4470-b903-390601c34032.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-8028-1EA - Each71399-80288f40c734-d0ae-4b7b-b57e-fa2447af662512021-03-02
71399-8028-2EA - Each71399-8028680ac178-d23a-4ab8-8b14-4417bd5e182312021-03-02

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
71399-802871399-8028-1, 71399-8028-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
GELATIN2G86QN327LIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
PROPYLPARABEN SODIUM625NNB0G9NIACT

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
5dfddb99-208f-4c76-8c59-3c13fd5fe52c0617dd75-2e5a-4470-b903-390601c340322023-02-25WarningsExact identifier
spl id: 5dfddb99-208f-4c76-8c59-3c13fd5fe52c
spl set id: 0617dd75-2e5a-4470-b903-390601c34032

Reported adverse events (FAERS/openFDA)#

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