FDA.reportPublic FDA data

Diphenhydramine HCL

Manufacturer
RPK Pharmaceuticals, Inc.
Effective date
2020-12-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:01:48

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 to 2 capsule                                      Children 6 to under 12 years 1 capsule Children under 6 years ask a doctor

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 25 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 haveTrouble urinating due to enlarged prostate glandA breathing problem such as emphysema or chronic bronchitisGlaucomaIf 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 to 2 capsule                                     
Children 6 to under 12 years
1 capsule
Children under 6 years
ask a doctor

Other information:

STORAGE AND HANDLING SECTION

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

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 53002-3140

NDC: 53002-3140-1 10 CAPSULE in a BOTTLE

NDC: 53002-3140-2 15 CAPSULE in a BOTTLE

NDC: 53002-3140-3 20 CAPSULE in a BOTTLE

NDC: 53002-3140-4 30 CAPSULE in a BOTTLE

Diphenhydramine HCl 25mg Capsules, USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-3140-12020-12-15C16284748780-19d75b9d0-e866-f424-e053-dadaa90a57ceDrug Facts
53002-3140-22020-12-15C16284748780-19d75b9d0-e866-f424-e053-dadaa90a57ceDrug Facts
53002-3140-32020-12-15C16284748780-19d75b9d0-e866-f424-e053-dadaa90a57ceDrug Facts
53002-3140-42020-12-15C16284748780-19d75b9d0-e866-f424-e053-dadaa90a57ceDrug Facts
53002-3140-12020-01-31C16284748780-19d75b9d0-e866-f424-e053-dadaa90a57ceDrug Facts
53002-3140-22020-01-31C16284748780-19d75b9d0-e866-f424-e053-dadaa90a57ceDrug Facts
53002-3140-32020-01-31C16284748780-19d75b9d0-e866-f424-e053-dadaa90a57ceDrug Facts
53002-3140-42020-01-31C16284748780-19d75b9d0-e866-f424-e053-dadaa90a57ceDrug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66424-020-01EA - Each66424-02062be7459-d627-4d56-af74-b18dfb1581dc12012-07-24
66424-020-10EA - Each66424-020cc145bd4-6e21-4bfe-a7b2-2ffe0528742b12012-07-24

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
53002-314053002-3140-3, 53002-3140-1, 53002-3140-4, 53002-3140-2
66424-020

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.6a520986-1004-4ee6-9a47-1dfd90bb1b2c2025-01-13WarningsExact identifier
ndc (product): 66424-020
d39fa341-a3ae-430f-ac2c-5763af91df55f6c232b6-7582-40ee-b146-8037f0a9622b2020-12-22WarningsExact identifier
spl set id: f6c232b6-7582-40ee-b146-8037f0a9622b

Reported adverse events (FAERS/openFDA)#

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