FDA.reportPublic FDA data

Benadryl

Manufacturer
Rebel Distributors Corp
Effective date
2011-04-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:27:45

Label at a glance#

ProductBenadryl Allergy
Active ingredientDiphenhydramine Hydrochloride
Label structure10 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 temporarily relieves these symptoms due to the common cold: runny nose sneezing

Dosage and administration

if needed, repeat dose every 4 to 6 hours do not take more than 6 times in 24 hours adults and children 12 years of age and over 1 to 2 gelcaps children 6 to under 12 years of age 1 gelcap children under 6 years of age do not use this product in children under 6 years of age

Storage and handling

each gelcap contains: calcium 35 mg store between 20-25°C (68-77°F). Avoid high humidity. do not use if carton is open or if blister unit is broken see side panel for lot number and expiration date

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each gelcap)

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:
    • 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

OTC - DO NOT USE SECTION

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

OTC - WHEN USING SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • if needed, repeat dose every 4 to 6 hours
  • do not take more than 6 times in 24 hours
adults and children 12 years of age and over1 to 2 gelcaps
children 6 to under 12 years of age1 gelcap
children under 6 years of agedo not use this product in children under 6 years of age

Other information

STORAGE AND HANDLING SECTION

  • each gelcap contains: calcium 35 mg
  • store between 20-25°C (68-77°F). Avoid high humidity.
  • do not use if carton is open or if blister unit is broken
  • see side panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, black iron oxide, butylparaben, carboxymethylcellulose sodium, crospovidone, D&C red #28, dibasic calcium phosphate dihydrate, edetate calcium disodium, FD&C red #40, gelatin, hypromellose, magnesium stearate, methylparaben, microcrystalline cellulose, polyethylene glycol, polysorbate 80, propylparaben, red iron oxide, sodium lauryl sulfate, sodium propionate, titanium dioxide, yellow iron oxide

Questions or comments?

OTC - QUESTIONS SECTION

call 1-877-717-2824

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Benadryl 25mg
Benadryl 25mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049632Benadryl 25 MG Oral TabletPSN1
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN1
1049632diphenhydramine hydrochloride 25 MG Oral Tablet [Benadryl]SBD1
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD1
1049632Benadryl 25 MG Oral TabletSY1
1049632Benadryl Allergy Ultratab 25 MG Oral TabletSY1

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
21695-811-242019-09-24C16284748780-1934fe258-4860-48b1-e053-8cdaa90a720aBenadryl ® ™ ALLERGY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-811-24BenadrylAllergy3 in 1 CARTONTABLET, COATED31
21695-811-24BenadrylAllergy8 in 1 BLISTER PACKTABLET, COATED81

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-811BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20110414_9c3fc14a-551c-4957-9074-6b27dfd4a29f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-811-24EA - Each21695-811bb6252be-aaf5-4596-b38c-fa9db66190f012012-07-24
50580-580-25EA - Each50580-5802dd4f587-8805-42cb-9034-7e5f6a32a9b912012-07-24
50580-580-49EA - Each50580-5809deaf86f-2a7a-4b87-b9e6-5682a479faae12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Diphenhydramine HydrochlorideACTIVE INGREDIENTTC2D6JAD401
DiphenhydramineACTIVE MOIETY8GTS82S83M1
butylparabenINACTIVE INGREDIENT3QPI1U3FV81

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21695-81121695-811-24
50580-580

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
Diphenhydramine HydrochlorideTC2D6JAD40ACTIB
butylparaben3QPI1U3FV8IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 15 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
butylparabenBUTYLPARABEN3QPI1U3FV8OINTMENT / TOPICAL0.18 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
butylparabenBUTYLPARABEN3QPI1U3FV8TABLET, COATED / ORAL0.08 mgExact identifier — unii candidate
15 equally ranked IID candidates
butylparabenBUTYLPARABEN3QPI1U3FV8CAPSULE, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
15 equally ranked IID candidates
butylparabenBUTYLPARABEN3QPI1U3FV8LOTION / TOPICAL4 mgExact identifier — unii candidate
15 equally ranked IID candidates
butylparabenBUTYLPARABEN3QPI1U3FV8DROPS / ORALNAExact identifier — unii candidate
15 equally ranked IID candidates
butylparabenBUTYLPARABEN3QPI1U3FV8TABLET / ORALNAExact identifier — unii candidate
15 equally ranked IID candidates
butylparabenBUTYLPARABEN3QPI1U3FV8SOLUTION / OPHTHALMIC0.02 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
butylparabenBUTYLPARABEN3QPI1U3FV8SUSPENSION / ORAL12 mgExact identifier — unii candidate
15 equally ranked IID candidates
butylparabenBUTYLPARABEN3QPI1U3FV8SOLUTION / ORAL6 mgExact identifier — unii candidate
15 equally ranked IID candidates
butylparabenBUTYLPARABEN3QPI1U3FV8CAPSULE / ORALNAExact identifier — unii candidate
15 equally ranked IID candidates
butylparabenBUTYLPARABEN3QPI1U3FV8SOLUTION / RECTAL0.01 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
butylparabenBUTYLPARABEN3QPI1U3FV8LIQUID / TOPICAL0.02 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
butylparabenBUTYLPARABEN3QPI1U3FV8TABLET, EXTENDED RELEASE / ORAL0.01 mgExact identifier — unii candidate
15 equally ranked IID candidates
butylparabenBUTYLPARABEN3QPI1U3FV8CREAM / TOPICAL0.4 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
butylparabenBUTYLPARABEN3QPI1U3FV8SYRUP / ORAL28.4 mg/1mlExact identifier — unii candidate
15 equally ranked IID candidates

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
9c3fc14a-551c-4957-9074-6b27dfd4a29f9c3fc14a-551c-4957-9074-6b27dfd4a29f2011-04-13WarningsExact identifier
spl id: 9c3fc14a-551c-4957-9074-6b27dfd4a29f
spl set id: 9c3fc14a-551c-4957-9074-6b27dfd4a29f

Reported adverse events (FAERS/openFDA)#

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