FDA.reportPublic FDA data

DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML

Manufacturer
AARNA USA INC.
Effective date
2025-04-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:00:09

Label at a glance#

ProductDIPHENHYDRAMINE HCL 12.5 MG PER 5 ML
Active ingredientDIPHENHYDRAMINE
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each 5 mL)

Diphenhydramine HCl 12.5 mg

OTC - PURPOSE SECTION

Purpose

Antihistamine

OTC - WHEN USING SECTION

Uses

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

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

WARNINGS SECTION

Warnings

Do not use

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

Ask a doctor before use if the child has

  • a breathing problem such as chronic bronchitis
  • glaucoma
  • a sodium restricted diet

Ask a doctor or pharmacist before use if the child is

taking sedatives or tranquilizers.

When using this product

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

Keep out of reach of children.

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

INDICATIONS & USAGE SECTION

Directions

  • do not take more than 6 doses in any 24 hours
  • take every 4 to 6 hours, or as directed by a doctor
  • mL = milliliter
  • keep dosing cup with product
  • find the right dose on the chart below

Age (yr)

Dose (mL)

children 6 to 11 years

5 mL to 10 mL

children 2 to 5 years

Do not use unless directed by a doctor

children under 2 years

Do not use

OTHER SAFETY INFORMATION

Other Information
each 5 mL contains: sodium 8 mg
Store between 20°- 25°C (68°-77°F). Do not refrigerate
protect from light

INACTIVE INGREDIENT SECTION

Inactive Ingredients
anhydrous citric acid, bubble gum favor, purified water,sodium benzoate, sodium citrate, saccharin sodium, sorbitol solution, sucrose.

OTC - QUESTIONS SECTION

Questions or comments?

Please Call 1(877) 225-6999

Manufactured for:

AARNA USA INC

Leland, NC 28451

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl® Allergy

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

22

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

33

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

44

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

77

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

55

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN3
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD3
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY3
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY3
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY3

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
82568-0016-4DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML118 mL in 1 BOTTLESOLUTION1183
82568-0016-6DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML473 mL in 1 BOTTLESOLUTION4733
82568-0016-8DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML236 mL in 1 BOTTLESOLUTION2363

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82568-0016DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML SOLUTION [AARNA USA INC.]3Current NDC, 3 package rows20250502_32c26835-f54e-d7e5-e063-6294a90ae1c0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82568-0016-4ML - Milliliter82568-001635c7c353-2342-4500-98d2-2480ea09f79e12025-06-13
82568-0016-6ML - Milliliter82568-00166b0be2fa-03eb-4541-af14-49f9b301ad0712025-06-13
82568-0016-8ML - Milliliter82568-001670c09490-6b01-4c56-9ed5-6cdc7beb09ee12025-06-13

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82568-001682568-0016-4, 82568-0016-8, 82568-0016-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL SOLUTION8KW3E207O2IACT
SODIUM SACCHARINSB8ZUX40TYIACT
SODIUM CITRATE1Q73Q2JULRIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SUCROSEC151H8M554IACT
DIPHENHYDRAMINE8GTS82S83MACTIB

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 12.5 MG PER 5 MLDIPHENHYDRAMINE HCL 12.5 MG PER 5 MLAARNA USA INC.32c26835-f54e-d7e5-e063-6294a90ae1c02025-04-30WarningsExact identifier
ndc (package): 82568-0016-8
ndc (package): 82568-0016-6
ndc (package): 82568-0016-4
ndc (product): 82568-0016
ndc11 (package): 82568001608
ndc11 (package): 82568001606
ndc11 (package): 82568001604
spl id: 3404aa22-166f-5501-e063-6394a90a1e7a
spl set id: 32c26835-f54e-d7e5-e063-6294a90ae1c0

Reported adverse events (FAERS/openFDA)#

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