FDA.reportPublic FDA data

Diphenhydramine Hydrochloride

Manufacturer
Bi-Mart | ELYSIUM PHARMACEUTICALS LIMITED
Effective date
2025-07-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:06:19

Label at a glance#

ProductDiphenhydramine Hydrochloride
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure11 sections

Indications and uses

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

Dosage and administration

take every 4 to 6 hours, or as directed by a doctor do not take not more than 6 times in 24 hours adults and children 12 years and over: 1 or 2 tablets children 6 to under 12 years: 1 tablet children under 6 years: do not use

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 other upper respiratory allergies:  

     o runny nose

     o sneezing

     o itchy, watery eyes

     o itchy of the nose or throat

  • temporarily relieves these symptoms of the common cold:

    o runny nose
    o 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

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

Ask a doctor or pharmacist before use if youaretaking sedatives or tranquilizers

When using this product

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives and othe tranquilizers may increase drowsiness
  • use caution 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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take every 4 to 6 hours, or as directed by a doctor
  • do not take not more than 6 times in 24 hours
  • adults and children 12 years and over:1 or 2 tablets
  • children 6 to under 12 years:1 tablet
  • children under 6 years:do not use

Other Information

OTHER SAFETY INFORMATION

  • each tablet contains:calcium 30 mg
  • each tablet contains:phosphorus 15 mg
  • store  at room temperature
  • protct from moisture
  • DO NOT USE IF  PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, phloxine B lake, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, titanium dioxide.

Questions?

OTC - QUESTIONS SECTION

call toll free 1-844-912-4012

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 37835-641-01

Compare to the active ingredients in Benadryl ®Allergy ULTRATAB ®Tablets.*

Allergy Medicine

Antihistamine

Diphenhydramine HCl 25 mg

100 Tablets

*This product is not manufactured or distributed by the owner of the registered trademark Benadryl ®Allergy ULTRATAB ®Tablets.

Distributed by:

BI-MART

Eugene, OR 97402

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN2
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD2

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
37835-641-01Diphenhydramine Hydrochloride100 in 1 BOTTLETABLET1002

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
37835-64137835-641-01

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
CROSCARMELLOSE SODIUMM28OL1HH48IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
D&C RED NO. 28767IP0Y5NHIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL532B59J990IACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
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
38f71fd9-448b-95d3-e063-6294a90a35232e7a9032-67d6-d408-e063-6394a90aca8c2025-07-02WarningsExact identifier
spl id: 38f71fd9-448b-95d3-e063-6294a90a3523
spl set id: 2e7a9032-67d6-d408-e063-6394a90aca8c

Reported adverse events (FAERS/openFDA)#

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