FDA.reportPublic FDA data

Diphenhydramine Hydrochloride

Manufacturer
Major Pharmaceuticals
Effective date
2026-02-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:46:50

Key Label Information#

Active Ingredients And Purpose

Drug Facts

Active ingredient (in each capsule) Diphenhydramine HCl 25 mg

OTC - PURPOSE SECTION

Purpose Antihistamine

Uses

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

Directions And Dosage

Directions

 take every 4 to 6 hours, or as directed by a doctor  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 of age do not use this product in children under 6 years of age

Other Label Information

INACTIVE INGREDIENT SECTION

corn starch, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, sodium lauryl sulfate

Questions or comments?

1-800-616-2471

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Major BENOPHEN NDC 0904-7237-24 Diphenhydramin HCl 25 mg Antihistamine For the temporary relief of the symptoms of: • Upper Respiratory Allergies • Hay Fever Compare to the active ingredient in BENADRYL® Allergy* 24 CAPSULES EACH CAPSULE INDIVIDUALLY BANDED FOR YOUR PROTECTION

Label Images#

0835K-24BB-Major-G2_IFC R53756_701309
0835K-24BB-Major-G2_IFC R53756_701309

DailyMed RxNorm Mappings#

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

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
0904-7237-24Diphenhydramine Hydrochloride2 in 1 CARTONCAPSULE24
0904-7237-24Diphenhydramine Hydrochloride12 in 1 BLISTER PACKCAPSULE124
0904-7237-60Diphenhydramine Hydrochloride100 in 1 BOTTLECAPSULE1004
0904-7237-61Diphenhydramine Hydrochloride10 in 1 BOX, UNIT-DOSECAPSULE104
0904-7237-61Diphenhydramine Hydrochloride10 in 1 BLISTER PACKCAPSULE104
0904-7237-80Diphenhydramine Hydrochloride1000 in 1 BOTTLECAPSULE10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7237-24EA - Each0904-72370f407112-e93a-4544-a880-485bfe00249e12022-11-07
0904-7237-60EA - Each0904-72370ee1a165-13f2-4f89-b39c-1c8f9e940d2812022-10-06
0904-7237-61EA - Each0904-72379d1b9365-5c30-45de-8071-c9a0262ad0c812023-01-09
0904-7237-80EA - Each0904-7237a9264169-ed21-468e-860b-7bb8a0f8406212022-11-07

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0904-72370904-7237-80, 0904-7237-60, 0904-7237-24, 0904-7237-61

Ingredients#

Name, UNII, Kind table
NameUNIIKind
D&C RED NO. 28767IP0Y5NHIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
MAGNESIUM STEARATE70097M6I30IACT
GELATIN2G86QN327LIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
SODIUM LAURYL SULFATE368GB5141JIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
STARCH, CORNO8232NY3SJIACT

Complete SPL Sections#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each capsule) Diphenhydramine HCl 25 mg

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

Purpose 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

Directions

DOSAGE & ADMINISTRATION SECTION

 take every 4 to 6 hours, or as directed by a doctor  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 of age do not use this product in children under 6 years of age

Other information

OTHER SAFETY INFORMATION

 store in a dry place at 15° – 30°C (59° – 86°F)

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

corn starch, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, sodium lauryl sulfate

Questions or comments?

OTC - QUESTIONS SECTION

1-800-616-2471

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Distributed by: MAJOR® PHARMACEUTICALS, Indianapolis, IN 46268 *This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Benadryl®. RETAIN CARTON FOR COMPLETE PRODUCT INFORMATION DO NOT USE IF CARTON IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN, OR SHOWS ANY SIGNS OF TAMPERING. DO NOT USE IF RED CAPSULE BAND IS BROKEN OR MISSING.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Major BENOPHEN NDC 0904-7237-24 Diphenhydramin HCl 25 mg Antihistamine For the temporary relief of the symptoms of: • Upper Respiratory Allergies • Hay Fever Compare to the active ingredient in BENADRYL® Allergy* 24 CAPSULES EACH CAPSULE INDIVIDUALLY BANDED FOR YOUR PROTECTION

Source Document#

Source XML