FDA.reportPublic FDA data

Diphenhydramine HCL STRAWBERRY FLAVOR

Manufacturer
Innovida Pharmaeutique Corporation
Effective date
2025-06-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:02:39

Label at a glance#

ProductDiphenhydramine HCL STRAWBERRY FLAVOR
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 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 Temporarily relieves these symptoms due to the common cold: runny nose sneezing

Dosage and administration

Take every 4 to 6 hours, or as directed by a doctor. Do not exceed recommended dose.  Adults and Children 12 years of age and over  take 10 to 20 mL (2 to 4 tsp) not to exceed 300 mg in 24 hours  Children 6 to under 12 years of age Children under 6 years of age:  take 5 to 10 mL (1 to 2 tsp) not to exceed 150 mg in 24 hours consult a doctor

Label contents#

Full prescribing information#

Active Ingredient (in each 5mL tsp)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl, 12.5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Warnings

WARNINGS SECTION

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 you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to the enlarged prostate gland

Ask a doctor or pharmacist before use if you are takingsedatives or tranquilizers

When using this product:

  • excitability might occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness effect
  • be careful when driving a motor vehicle or operating machinery

If pregnant of breast-feeding, ask a health professional before use.

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.

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

Temporarily relieves these symptoms due to the common cold:

  • runny nose
  • sneezing

Directions

DOSAGE & ADMINISTRATION SECTION

  • Take every 4 to 6 hours, or as directed by a doctor.
  • Do not exceed recommended dose.
 Adults and Children 12 years of age and over take 10 to 20 mL (2 to 4 tsp) not to exceed 300 mg in 24 hours

 Children 6 to under 12 years of age

Children under 6 years of age:

 take 5 to 10 mL (1 to 2 tsp) not to exceed 150 mg in 24 hours

consult a doctor

Other Information

SPL UNCLASSIFIED SECTION

  • Store at controlled room temperature 15º - 30ºC (59º - 86ºF).
  • Do not refrigerate. Avoid excessive heat or humidity.
  • Protect from light.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Citric acid, FD&C red #40, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sorbitol, strawberry flavor, sucralose.

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF SEAL UNDER CAP IS TORN, BROKEN OR MISSING.

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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
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
71800-058-19Diphenhydramine HCL STRAWBERRY FLAVOR119 mL in 1 BOTTLESOLUTION1191

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71800-058-19ML - Milliliter71800-058d3de1998-9883-4792-b903-67cf9b6f8a0312025-07-08

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71800-05871800-058-19

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID2968PHW8QPIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
STRAWBERRY4J2TY8Y81VIACT
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 STRAWBERRY FLAVORDIPHENHYDRAMINE HCLInnovida Pharmaeutique Corporation7eb709a5-c587-4f1d-bc2d-576d07a3a3bf2025-06-04WarningsExact identifier
ndc (package): 71800-058-19
ndc (product): 71800-058
ndc11 (package): 71800005819
spl id: 36c01631-ab1a-2489-e063-6294a90a5569
spl set id: 7eb709a5-c587-4f1d-bc2d-576d07a3a3bf

Reported adverse events (FAERS/openFDA)#

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