FDA.reportPublic FDA data

Diphenhydramine Hydrochloride Oral Solution USP Drug Facts

Manufacturer
American Health Packaging
Effective date
2024-08-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:16:41

Label at a glance#

ProductDiphenhydramine HCl
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

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

Dosage and administration

find right dose on chart below mL = milliliter take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hours Age (yr) Dose (mL) children under 2 years do not use children 2 to 5 years do not use unless directed by a doctor children 6 to 11 years 5 mL to 10 mL

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 12.5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms due to hay fever or other upper 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

Ask a doctor or pharmacist

OTC - ASK DOCTOR/PHARMACIST SECTION

before use if the child is taking 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

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. (1-800-222-1222)

Directions:

DOSAGE & ADMINISTRATION SECTION

  • find right dose on chart below
  • mL = milliliter
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
Age (yr)Dose (mL)

children under 2 years

do not use

children 2 to 5 years

do not use unless directed by a doctor

children 6 to 11 years

5 mL to 10 mL

Other information

SPL UNCLASSIFIED SECTION

  • each 5 mL contains: sodium 10 mg
  • store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used.

Diphenhydramine HCl Oral Solution, USP is a clear, cherry flavored liquid supplied in the following:
5 mL unit dose cups: 100 cups (10 x 10) NDC 60687-829-86

Inactive ingredients:

INACTIVE INGREDIENT SECTION

citric acid anhydrous, glycerin, flavoring, purified water, saccharin sodium, sodium benzoate, sodium carboxymethylcellulose, sodium citrate, sorbitol.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-845-8210

DO NOT USE IF SEAL IS BROKEN.

Distributed by:
American Health Packaging
Columbus, OH 43217

R02/24

Principal Display Panel - Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diphenhydramine Hydrochloride Oral Solution USP LabelDiphenhydramine Hydrochloride Oral Solution USP Label

100 Count Case NDC 60687-829-86
Cup NDC 60687-829-40

Diphenhydramine Hydrochloride
Oral Solution USP

12.5 mg/5 mL

Antihistamine/Allergy
Alcohol Free/Dye Free/Sugar Free

Usual Dosage: See attached Drug Facts

Store at 20° to 25°C (68° to 77°F)

For Institutional Use Only

10 x 5 mL Unit-Dose Cups

T0865C050224       R02/24

Principal Display Panel – Cup – 12.5 mg/5 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

12.5 mg/5 mL Diphenhydramine Hydrochloride Oral Solution USP Cup Label12.5 mg/5 mL Diphenhydramine Hydrochloride Oral Solution USP Cup Label

NDC 60687- 829-40

Diphenhydramine
Hydrochloride
Oral Solution USP

12.5 mg/5 mL

Antihistamine/Allergy
Alcohol Free/Dye Free/Sugar Free

Delivers 5 mL

Sodium Content: 10 mg/5 ml

See package Drug Facts insert for full
prescribing information and storage.

For Institutional Use Only.

American Health Packaging
Columbus, OH 43217

A0865C050224

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
60687-829-40Diphenhydramine HCl5 mL in 1 CUP, UNIT-DOSESOLUTION51
60687-829-46Diphenhydramine HCl10 in 1 TRAYSOLUTION101
60687-829-86Diphenhydramine HCl10 in 1 CASESOLUTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-829DIPHENHYDRAMINE HCL (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [AMERICAN HEALTH PACKAGING]1Current NDC, 3 package rows20240807_4cd8aee3-5522-434b-a1b1-9591bed3e9a6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-829-40ML - Milliliter60687-8294229f2cb-2587-4f47-977d-9101e08eaefa12024-08-12
60687-829-86ML - Milliliter60687-829b1a76687-7b8c-4093-b22a-a673a2357bcb12024-08-12

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60687-82960687-829-40, 60687-829-46, 60687-829-86

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
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 HClDIPHENHYDRAMINE HYDROCHLORIDEAmerican Health Packaging4cd8aee3-5522-434b-a1b1-9591bed3e9a62024-08-04WarningsExact identifier
ndc (package): 60687-829-46
ndc (package): 60687-829-40
ndc (package): 60687-829-86
ndc (product): 60687-829
ndc11 (package): 60687082940
ndc11 (package): 60687082986
ndc11 (package): 60687082946
spl id: 1d639138-d6a9-588b-e063-6394a90a2bb9
spl set id: 4cd8aee3-5522-434b-a1b1-9591bed3e9a6

Reported adverse events (FAERS/openFDA)#

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