Diphenhydramine Hydrochloride 25mg

Manufacturer
Strive Pharmaceuticals Inc
Effective date
2024-12-11
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:52:13

Label at a glance#

ProductDiphenhydramine Hydrochloride 25mg
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or 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, or as directed by doctor • do not take more than 6 times in 24 hours  adults and children 12 years and older  1 to 2 tablets  children 6 to under 12 years  1 tablet  children under 6 years old  do not use

Storage and handling

•  each tablet contains: calcium 18.64 mg • store between 20-25°C (68-77°F) • protect from light.

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever or 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

WARNINGS SECTION

Do not use
• to make a child sleepy
• with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have
• 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 taking sedatives or tranquilizers.

When using this product
• 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, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

• take every 4 to 6 hours, or as directed by doctor
• do not take more than 6 times in 24 hours

 adults and children 12 years and older 1 to 2 tablets
 children 6 to under 12 years 1 tablet
 children under 6 years old do not use

Other information

STORAGE AND HANDLING SECTION

• each tablet contains: calcium 18.64 mg
• store between 20-25°C (68-77°F)
• protect from light.

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dicalcium phosphate, D&C red #27, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-577-8033 Monday-Friday 8am-4pm EST

SPL UNCLASSIFIED SECTION

RIGHT REMEDIES

Compare to the active ingredient of Benadryl® Allergy ULTRATAB®*

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl® Allergy ULTRATAB® 

Distributed by:
Strive Pharmaceuticals Inc.
East Brunswick, NJ 08816

Product of India
Packaged and Quality Assured in the USA

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING 

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Strive-148-1Strive-148-1

Strive-148-2Strive-148-2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN5
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD5

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
70692-148-01Diphenhydramine Hydrochloride 25mg100 in 1 PACKAGETABLET1005
70692-148-11Diphenhydramine Hydrochloride 25mg1000 in 1 BOTTLETABLET10005
70692-148-40Diphenhydramine Hydrochloride 25mg400 in 1 BOTTLETABLET4005
70692-148-46Diphenhydramine Hydrochloride 25mg72 in 1 BOTTLETABLET725
70692-148-46Diphenhydramine Hydrochloride 25mg1 in 1 CARTONTABLET15
70692-148-62Diphenhydramine Hydrochloride 25mg600 in 1 BOTTLETABLET6005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70692-148DIPHENHYDRAMINE HYDROCHLORIDE 25MG TABLET [STRIVE PHARMACEUTICALS INC]5Current NDC, Legacy NDC, 6 package rows20250112_b440eb2e-4de9-2b65-e053-2995a90abda8.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70692-14870692-148-01, 70692-148-46, 70692-148-40, 70692-148-62, 70692-148-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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 Hydrochloride 25mgDIPHENHYDRAMINE HYDROCHLORIDE 25MGStrive Pharmaceuticals Incb440eb2e-4de9-2b65-e053-2995a90abda82024-12-11WarningsExact identifier
ndc (package): 70692-148-62
ndc (package): 70692-148-40
ndc (package): 70692-148-46
ndc (package): 70692-148-01
ndc (package): 70692-148-11
ndc (product): 70692-148
ndc11 (package): 70692014811
ndc11 (package): 70692014801
ndc11 (package): 70692014846
ndc11 (package): 70692014840
ndc11 (package): 70692014862
spl id: ec06fc1c-c111-4d17-b42f-9817a45bf385
spl set id: b440eb2e-4de9-2b65-e053-2995a90abda8

Reported adverse events (FAERS/openFDA)#

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