FDA.reportPublic FDA data

Diphenhydramine HCL

Manufacturer
Proficient Rx LP
Effective date
2024-01-01
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:08:08

Label at a glance#

ProductDiphenhydramine HCL
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure11 sections

Indications and uses

• Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies. • Sneezing. • Nasal congestion. • Runny nose. • Itchy, watery eyes.

Dosage and administration

• Take every 4-6 hours • Do not take more than 6 doses in 24 hours. Adults and children 12 years or over 1 capsule                                      Children under 12 years ask a doctor **25 mg strength is not available in this package. Do not attempt to break capsules.

Storage and handling

• Store at room temperature 15-30  degrees C (59-86 degrees F) • Protect from excessive moisture

Label contents#

Full prescribing information#

Active ingredient(in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCL 50 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses:

INDICATIONS & USAGE SECTION

  • Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies.
  • Sneezing.
  • Nasal congestion.
  • Runny nose.
  • Itchy, watery eyes.

Do not use

OTC - DO NOT USE SECTION

  • With any other product containing Diphenhydramine HCL, including one applied topically.

Ask a doctor or pharmacist before use

OTC - ASK DOCTOR/PHARMACIST SECTION

If you have

  • Trouble urinating due to enlarged prostate gland
  • A breathing problem such as emphysema or chronic bronchitis
  • Glaucoma
  • If you are taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • Avoid alcoholic drinks.
  • Marked drowsiness may occur.
  • Excitability may occur, especially in children.
  • Alcohol, sedatives and tranquilizers may increase drowsiness.
  • Be careful when driving a motor vehicle or operating machinery.

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 right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Take every 4-6 hours
  • Do not take more than 6 doses in 24 hours.

Adults and children 12 years or over

1 capsule                                     

Children under 12 years

ask a doctor

**25 mg strength is not available in this package. Do not attempt to break capsules.

Other information:

STORAGE AND HANDLING SECTION

  • Store at room temperature 15-30  degrees C (59-86 degrees F)
  • Protect from excessive moisture

Questions? Adverse drug event call:

OTC - QUESTIONS SECTION

1-800-687-0176

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

63187-866-30
63187-866-30

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN5
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD5
1020477diphenhydramine HCl 50 MG Oral CapsuleSY5

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
63187-866-10Diphenhydramine HCL10 in 1 BOTTLE, PLASTICCAPSULE105
63187-866-30Diphenhydramine HCL30 in 1 BOTTLE, PLASTICCAPSULE305
63187-866-60Diphenhydramine HCL60 in 1 BOTTLE, PLASTICCAPSULE605
63187-866-90Diphenhydramine HCL90 in 1 BOTTLE, PLASTICCAPSULE905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-866DIPHENHYDRAMINE HCL CAPSULE [PROFICIENT RX LP]5Current NDC, Legacy NDC, 4 package rows20240201_6e91b9c3-57e8-488b-ac70-d863cdf9d6e8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-866-30EA - Each63187-866fc05308c-f8cc-4834-8e27-c6d7bc05127c12017-08-11
66424-021-01EA - Each66424-0219776653f-7c63-4b8b-a643-b1ff6450406412012-07-24
66424-021-10EA - Each66424-021fa4dd348-3929-4217-a7fb-c7f312f780c812012-07-24

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63187-86663187-866-10, 63187-866-30, 63187-866-60, 63187-866-90
66424-021

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
FERROSOFERRIC OXIDEXM0M87F357IACT
D&C RED NO. 28767IP0Y5NHIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM LAURYL SULFATE368GB5141JIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HCLDIPHENHYDRAMINE HCLSDA Laboratories, Inc.437e6a13-a4ff-4f98-8973-042f224ee85e2025-01-13WarningsExact identifier
ndc (product): 66424-021
Diphenhydramine HCLDIPHENHYDRAMINE HCLProficient Rx LP6e91b9c3-57e8-488b-ac70-d863cdf9d6e82024-01-01WarningsExact identifier
ndc (package): 63187-866-10
ndc (package): 63187-866-60
ndc (package): 63187-866-90
ndc (package): 63187-866-30
ndc (product): 63187-866
ndc11 (package): 63187086660
ndc11 (package): 63187086690
ndc11 (package): 63187086630
ndc11 (package): 63187086610
spl id: d27b1389-9287-4f39-91de-0d76a87f4e05
spl set id: 6e91b9c3-57e8-488b-ac70-d863cdf9d6e8

Reported adverse events (FAERS/openFDA)#

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