FDA.reportPublic FDA data

Diphenhydramine HCl Oral Solution

Manufacturer
Everpharm LLC
Effective date
2025-01-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:53:08

Label at a glance#

ProductDiphenhydramine HCl Oral Solution
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure14 sections

Indications and uses

Temporarily relieves these symptoms due to hay fever or other respiratory allergies:    • runny nose                   • sneezing      • itchy, watery eyes         • itching of the nose or throat

Dosage and administration

For the 5 mL Unit-Dose:  • take every 4 to 6 hours, or as directed by a physician • do not take more than 6 doses in 24 hours age dose Children under 2 years of age Do not use Children 2 to under 6 years of age Do not use unless directed by a doctor Children 6 to under 12 years of age 5 mL (12.5 mg) to 10 mL (25 mg)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient per 5 mL (1 Unit Dose)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 12.5 mg

Active ingredient per 10 mL (1 Unit Dose)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves these symptoms due to hay fever or other respiratory allergies:

   • runny nose                   • sneezing  

   • itchy, watery eyes         • itching of the nose or throat

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

• to make a child sleepy
• with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if the child has

OTC - ASK DOCTOR SECTION

• a breathing problem such as chronic bronchitis
• glaucoma

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if the child istaking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

• marked drowsiness may occur
• sedatives and tranquilizers may increase drowsiness
• excitability may occur, especially in children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Directions 

DOSAGE & ADMINISTRATION SECTION

For the 5 mL Unit-Dose: 

• take every 4 to 6 hours, or as directed by a physician

• do not take more than 6 doses in 24 hours

agedose
Children under 2 years of ageDo not use
Children 2 to under 6 years of ageDo not use unless directed by a doctor
Children 6 to under 12 years of age5 mL (12.5 mg) to 10 mL (25 mg)

Directions

DOSAGE & ADMINISTRATION SECTION

For the 10 mL Unit-Dose:

• take every 4 to 6 hours, or as directed by a physician
• do not take more than 6 doses in 24 hours

agedose
Children under 6 years of age                   Do not use
Children 6 to under 12 years of age               10 mL (25 mg)
Adults and children 12 years of age and over 10 mL (25 mg) to 20 mL (50 mg) 

Other information

SPL UNCLASSIFIED SECTION

• each 5 mL contains sodium: 3 mg
• store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
• do not use if lid is torn or broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients: citric acid, flavor, FD&C red#40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose

Questions or comments?

OTC - QUESTIONS SECTION

Questions or comments? (866) 838-3774

SPL UNCLASSIFIED SECTION

Distributed by:

EverPharm, LLC

14A Winthrop St

Marlborough, MA 01752

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EverPharm

NDC 84415-012-01

Diphenhydramine HCL

Oral Solution

Antihistamine

12.5 mg/5 mL

• Alcohol Free

• Sugar Free

• Cherry Flavor

For Institutional Use Only

100 x 5 mL Unit-Dose Cups

5label5label

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EverPharm

NDC 84415-013-01

Diphenhydramine HCL

Oral Solution

Antihistamine

25 mg/10 mL

• Alcohol Free

• Sugar Free

• Cherry Flavor

For Institutional Use Only

100 x 10 mL Unit-Dose Cups

10label10label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN1
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD1
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY1
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY1
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY1

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
84415-012-01Diphenhydramine HCl Oral Solution5 mL in 1 CUP, UNIT-DOSESOLUTION51
84415-012-01Diphenhydramine HCl Oral Solution100 in 1 BOX, UNIT-DOSESOLUTION1001
84415-013-01Diphenhydramine HCl Oral Solution10 mL in 1 CUP, UNIT-DOSESOLUTION101
84415-013-01Diphenhydramine HCl Oral Solution100 in 1 BOX, UNIT-DOSESOLUTION1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84415-012DIPHENHYDRAMINE HCL ORAL SOLUTION (DIPHENHYDRAMINE HCL ORAL) SOLUTION [EVERPHARM LLC]1Current NDC, 2 package rows20250119_d7aaf874-69ac-49cf-93be-6d4a38b9a557.zip
84415-013DIPHENHYDRAMINE HCL ORAL SOLUTION (DIPHENHYDRAMINE HCL ORAL) SOLUTION [EVERPHARM LLC]1Current NDC, 2 package rows20250119_d7aaf874-69ac-49cf-93be-6d4a38b9a557.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
84415-013-01ML - Milliliter84415-0134a6ea4c8-4ad2-4c47-9a02-1ef93f62841e12025-05-14
84415-012-01ML - Milliliter84415-01270a458ce-939c-46d2-af0e-ca6a0fd1cc2d12025-05-14

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
84415-01384415-013-01
84415-01284415-012-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C RED NO. 40WZB9127XOAIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM CITRATE1Q73Q2JULRIACT
SUCRALOSE96K6UQ3ZD4IACT
WATER059QF0KO0RIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C RED NO. 40WZB9127XOAIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM CITRATE1Q73Q2JULRIACT
SUCRALOSE96K6UQ3ZD4IACT
WATER059QF0KO0RIACT
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HCl Oral SolutionDIPHENHYDRAMINE HCL ORALEverpharm LLCd7aaf874-69ac-49cf-93be-6d4a38b9a5572025-01-16WarningsExact identifier
ndc (package): 84415-012-01
ndc (package): 84415-013-01
ndc (product): 84415-012
ndc (product): 84415-013
ndc11 (package): 84415001301
ndc11 (package): 84415001201
spl id: 2bd97cb8-2b08-aa8d-e063-6394a90ad19d
spl set id: d7aaf874-69ac-49cf-93be-6d4a38b9a557

Reported adverse events (FAERS/openFDA)#

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