FDA.reportPublic FDA data

Diphenhydramine HCL 25 mg Capsules

Manufacturer
Reliable 1 Laboratories LLC
Effective date
2025-01-15
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:52:52

Label at a glance#

ProductDiphenhydramine HCl 25 mg
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure17 sections

Indications and uses

temporarily releaves these symptoms of hay fever or other upper respiratory allergies: runny nose itchy nose or throat sneezing 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 and over 1 to 2 capsules children 6 to under 12 years 1 capsule children under 6 years do not use

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 releaves these symptoms of hay fever or other upper respiratory allergies:

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

Warnings

WARNINGS SECTION

Do not use

  • with any otherprodcut containing diphenhydramine, even one use on skin
  • to make a child sleepy

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 pharamcist before use if you are taking sedatives or tranquilizers

Drug Facts continued of back of label

OTC - WHEN USING SECTION

When using this product

  • you may get very drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives, & 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take every 4-6 hours
  • do not take more than 6 doses in 24 hours
adults and children 12 years and over

1 to 2 capsules

children 6 to under 12 years

1 capsule

children under 6 yearsdo not use

Other information

OTHER SAFETY INFORMATION

  • store at room temperature
  • protect from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS BROKEN OR MISSING

SPL UNCLASSIFIED SECTION

Distributed by: Reliable 1 Laboratories LLC

Valley Stream, NY 11580

www.reliable1labs.com

SPL UNCLASSIFIED SECTION

Drug Facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69618-024-01

Diphenhydramine HCL 25 mg

ANTIHISTAMINE

100 CAPSULES

DIPHENHYDRAMINE 25 CAPSULESDIPHENHYDRAMINE 25 CAPSULES

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN6
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD6

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69618-024-012023-03-29C16284748780-1f386c64a-1896-0266-e053-dadaa90a7c1aDiphenhydramine HCL 25 mg Capsules
69618-024-012023-01-30C16284748780-1f386c64a-1896-0266-e053-dadaa90a7c1aDiphenhydramine HCL 25 mg Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69618-024-01Diphenhydramine HCl 25 mg100 in 1 BOTTLE, PLASTICCAPSULE1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69618-024DIPHENHYDRAMINE HCL 25 MG (DIPHENHYDRAMINE HCL) CAPSULE [RELIABLE 1 LABORATORIES LLC]6Current NDC, Legacy NDC, 1 package rows20250117_32fa40ad-fed5-586f-e054-00144ff88e88.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-024-01EA - Each69618-0248be65923-d60d-4f3b-a337-8be559b0e6fc12016-06-14

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69618-02469618-024-01

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
D&C RED NO. 28767IP0Y5NHIACT
METHYLPARABENA2I8C7HI9TIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
SODIUM LAURYL SULFATE368GB5141JIACT
GELATIN2G86QN327LIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLPARABENZ8IX2SC1OHIACT
BENZYL ALCOHOLLKG8494WBHIACT
BUTYLPARABEN3QPI1U3FV8IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
LACTOSEJ2B2A4N98GIACT
MAGNESIUM STEARATE70097M6I30IACT

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 HCl 25 mgDIPHENHYDRAMINE HCLReliable 1 Laboratories LLC32fa40ad-fed5-586f-e054-00144ff88e882025-01-15WarningsExact identifier
ndc (package): 69618-024-01
ndc (product): 69618-024
ndc11 (package): 69618002401
spl id: 2bc84c78-287a-70e5-e063-6394a90a01c3
spl set id: 32fa40ad-fed5-586f-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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