FDA.reportPublic FDA data

Diphenydramine HCl Oral Solution, USP

Manufacturer
PAI Holdings, LLC dba PAI Pharma | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma
Effective date
2024-01-05
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:19:15

Label at a glance#

ProductDiphenhydramine HCl
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure11 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 Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist 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

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. (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 yearsdo not use
children 2 to 5 yearsdo not use unless directed by a doctor
children 6 to 11 years5 mL to 10 mL

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

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.

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Delivers 5 mL

NDC 0121-0865-05

Diphenydramine HCl Oral Solution USP

12.5 mg/5 mL

Antihistamine/Allergy

Alcohol Free/Dye Free/Sugar Free

Package Not Child-Resistant

Principal Display Panel
Principal Display Panel

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Delivers 10 mL

NDC 0121-1730-10

Diphenydramine HCl Oral Solution USP

25 mg/10 mL

Antihistamine/Allergy

Alcohol Free/Dye Free/Sugar Free

Package Not Child-Resistant

Principal Display Panel
Principal Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN5
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD5
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY5
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY5
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY5

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-0865-00Diphenhydramine HCl10 in 1 CASESOLUTION105
0121-0865-00Diphenhydramine HCl10 in 1 TRAYSOLUTION105
0121-0865-05Diphenhydramine HCl5 mL in 1 CUP, UNIT-DOSESOLUTION55
0121-0865-30Diphenhydramine HCl10 in 1 TRAYSOLUTION105
0121-0865-30Diphenhydramine HCl3 in 1 CASESOLUTION35
0121-1730-00Diphenhydramine HCl10 in 1 CASESOLUTION105
0121-1730-00Diphenhydramine HCl10 in 1 TRAYSOLUTION105
0121-1730-10Diphenhydramine HCl10 mL in 1 CUP, UNIT-DOSESOLUTION105
0121-1730-30Diphenhydramine HCl3 in 1 CASESOLUTION35
0121-1730-30Diphenhydramine HCl10 in 1 TRAYSOLUTION105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0865DIPHENHYDRAMINE HCL (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]5Current NDC, Legacy NDC, 5 package rows20240911_3c3e0dc8-cddd-4f46-9b68-19bac00c07cc.zip
0121-1730DIPHENHYDRAMINE HCL (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]5Current NDC, Legacy NDC, 5 package rows20240911_3c3e0dc8-cddd-4f46-9b68-19bac00c07cc.zip

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
0121-08650121-0865-05, 0121-0865-00, 0121-0865-30
0121-17300121-1730-10, 0121-1730-00, 0121-1730-30

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
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SORBITOL506T60A25RIACT

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 HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma3c3e0dc8-cddd-4f46-9b68-19bac00c07cc2024-01-05WarningsExact identifier
ndc (package): 0121-0865-00
ndc (package): 0121-1730-10
ndc (package): 0121-1730-00
ndc (package): 0121-0865-30
ndc (package): 0121-0865-05
ndc (package): 0121-1730-30
ndc (product): 0121-1730
ndc (product): 0121-0865
ndc11 (package): 00121173030
ndc11 (package): 00121173000
ndc11 (package): 00121086530
ndc11 (package): 00121173010
ndc11 (package): 00121086500
ndc11 (package): 00121086505
spl id: d56f4fe1-e90c-4e35-a488-12c93938a3dd
spl set id: 3c3e0dc8-cddd-4f46-9b68-19bac00c07cc

Reported adverse events (FAERS/openFDA)#

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