FDA.reportPublic FDA data

Diphenhydramine Hydrochloride

Manufacturer
RedPharm Drug, Inc.
Effective date
2021-01-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:36:55

Label at a glance#

ProductDiphenhydramine Hydrochloride
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies: runny nose sneezing itchy nose or throat itchy, watery eyes

Dosage and administration

adults & children 12 years and over: take 1-2 capsules every 4-6 hours; not more than 6 does in 24 hours ​children under 12 years: ask a doctor

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 of hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy nose or throat
  • itchy, watery eyes

WARNINGS

WARNINGS SECTION

​Do not use​ with any other product containing diphenhydramine, even one used on skin

​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

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

​When using this product

  • ​you may get very drowsy
  • 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

​If pregnant or breast-feeding​, ask a health professional before use.

​

KEEP OUT OF THE REACH OF CHILDREN.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Venter right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • adults & children 12 years and over: take 1-2 capsules every 4-6 hours; not more than 6 does in 24 hours
  • ​children under 12 years: ask a doctor

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

  • store at 15°-30°C (59°-86°F)
  • protect from moisture
  • This is a bulk package. Dispense contents in a tight, light-resistant container with a child-resistant closure as defined in the USP

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

benzyl alcohol, butylparaben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium lauryl sulfate

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

call ​888-374-279​ 1, 8:30 am - 4:30 pm ET, Monday - Friday

​TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFTEY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED

​Distributed by:

Epic Pharma, LLC

Laurelton, NY

11413

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABELLABEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN2
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD2

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
67296-1645-12023-01-30C16284748780-1f386c649-d277-0266-e053-dadaa90a7c1aDiphenhydramine 25mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1645-1Diphenhydramine Hydrochloride24 in 1 BOTTLECAPSULE242

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1645DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [REDPHARM DRUG, INC.]2Legacy NDC, 1 package rows20210115_88f1ac7b-31a1-0636-e053-2a95a90a5001.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-648-10EA - Each42806-648101d637c-4636-4598-9c22-bc9eca653b2b12017-04-05

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67296-164567296-1645-1
42806-648

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZYL ALCOHOLLKG8494WBHIACT
BUTYLPARABEN3QPI1U3FV8IACT
D&C RED NO. 28767IP0Y5NHIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN2G86QN327LIACT
LACTOSEJ2B2A4N98GIACT
MAGNESIUM STEARATE70097M6I30IACT
METHYLPARABENA2I8C7HI9TIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM LAURYL SULFATE368GB5141JIACT
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b8df8cb5-109f-58db-e053-2a95a90a831388f1ac7b-31a1-0636-e053-2a95a90a50012021-01-14WarningsExact identifier
spl id: b8df8cb5-109f-58db-e053-2a95a90a8313
spl set id: 88f1ac7b-31a1-0636-e053-2a95a90a5001
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEEpic Pharma, LLCa083dec1-d4a7-4573-8a14-f5739d5bf1532016-11-22WarningsExact identifier
ndc (product): 42806-648

Reported adverse events (FAERS/openFDA)#

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