Diphenhydramine HCL

Manufacturer
Belleview Biosciences
Effective date
2025-06-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:02:50

Label at a glance#

ProductDiphenhydramine HCL
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Directions: Take every 4-6 hours, or as directed by doctor. * Do NOT exceed the recommended dose

AgeDose
Adults and Children 12 years of age and overtake 10 to 20 mL (2 to 4 tsp), not to exceed 300 mg in 24 hours
Children 6 to under 12 years of agetake 5 to 10 mL (1 to 2 tsp) not to exceed 150 mg in 24 hours
Children under 6 years of ageConsult a doctor

WARNINGS SECTION

Warnings:

Do not use: ■ with any other product containing

diphenhydramine, even one used on skin ■ to make a

child sleepy

Ask a doctor before use if you have: ■ a breathing

problem such as emphysema or chronic bronchitis

■ glaucoma ■ trouble urinating due to the enlarged

prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product: ■ excitability might occur,

especially in children ■ marked drowsiness may occur

■ avoid alcoholic drinks ■ alcohol, sedatives, and

tranquilizers may increase drowsiness effect ■ be careful

when driving a motor vehicle or operating machinery

If pregnant or breast-feeding, ask a health

professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a

Poison Control Center (1-800-222-1222) right away.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Citric Acid,

Flavor, Methylparaben, Monoammonium

Glycyrrhizinate, Potassium Citrate, Propylene Glycol,

Propylparaben, Purified Water, Sorbitol, Sucralose

INDICATIONS & USAGE SECTION

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

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 (1-800-222-1222) right away.

OTC - PURPOSE SECTION

Purpose: Antihistamine

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each 5 mL tsp)

Diphenhydramine HCL, 12.5 mg

Drug Facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bulk LabelBulk Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN2
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD2
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY2
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY2
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY2

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
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84447-103-01Diphenhydramine HCL200000 mL in 1 DRUMSOLUTION2000002
84447-103-04Diphenhydramine HCL118 mL in 1 BOTTLE, PLASTICSOLUTION1182
84447-103-16Diphenhydramine HCL473 mL in 1 BOTTLE, PLASTICSOLUTION4732

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
84447-103-16ML - Milliliter84447-1033fbeb6a1-3362-4f18-b499-87b41d9d205c12025-07-08

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
84447-10384447-103-16, 84447-103-04, 84447-103-01

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 HCLDIPHENHYDRAMINE HCLBelleview Biosciences1db57d86-39f0-f8ca-e063-6394a90a63972025-06-12WarningsExact identifier
ndc (package): 84447-103-16
ndc (package): 84447-103-01
ndc (package): 84447-103-04
ndc (product): 84447-103
ndc11 (package): 84447010304
ndc11 (package): 84447010316
ndc11 (package): 84447010301
spl id: 3765beab-e853-b34f-e063-6394a90ac9d5
spl set id: 1db57d86-39f0-f8ca-e063-6394a90a6397

Reported adverse events (FAERS/openFDA)#

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