FDA.reportPublic FDA data

Diphenhydramine Oral Liquid

Manufacturer
Rising Pharma Holdings, Inc. | Invahealth Inc.
Effective date
2024-10-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:27:33

Label at a glance#

ProductDiphenhydramine Oral Liquid
Active ingredientDiphenhydramine Hydrochloride
Label structure8 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

Storage and handling

store at room temperature 15º - 30ºC (59º - 86ºF) protect from freezing protect from light each teaspoon (5 mL) contains: sodium 8 mg TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient in each 5 mL ( in one teaspoonful)

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

temporarily relieves these symptoms due to the common cold:

  • runny nose
  • sneezing

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • with any other product containing diphenhydramine, even one used on skin.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis.
  • a sodium-restricted diet

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take every 4-6 hours
  • Do not use more than 6 dose in 24 hours
adults and children 12 years of age and over2 to 4 teaspoonfuls (25 to 50 mg)
children 6 to under 12 years of age1 to 2 teaspoonfuls (12.5 to 25 mg)
children under 6 yearsask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature 15º - 30ºC (59º - 86ºF)
  • protect from freezing
  • protect from light
  • each teaspoon (5 mL) contains: sodium 8 mg

TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.

Inactive ingredients

INACTIVE INGREDIENT SECTION

cherry flavor, citric acid, D & C Red #33, FD & C Red #40, flavor, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, sucrose, water.

Questions or comments?

SPL UNCLASSIFIED SECTION

1-844-474-7464

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rising Health, LLC

NDC 57237-305-12

Diphenhydramine Hcl 12.5 mg/5 mL Oral Solution

4 fl oz (118 mL)diphenhydramine-labeldiphenhydramine-label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN2
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD2
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY2
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY2
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY2

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
57237-305-12Diphenhydramine Oral Liquid118 mL in 1 BOTTLELIQUID1182
57237-305-16Diphenhydramine Oral Liquid473 mL in 1 BOTTLELIQUID4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-305DIPHENHYDRAMINE ORAL LIQUID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [RISING PHARMA HOLDINGS, INC.]2Current NDC, Legacy NDC, 2 package rows20241020_d8462e6f-a9fb-4701-97e2-d81a47f3e196.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-305-12ML - Milliliter57237-305aa05f7f2-8b91-47a3-95ec-9e97e34984c812023-02-06
57237-305-16ML - Milliliter57237-3059a997a67-be7c-4cef-a004-9a8394d8822812023-02-06

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
57237-30557237-305-12, 57237-305-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
Diphenhydramine HydrochlorideTC2D6JAD40ACTIB
Anhydrous Citric AcidXF417D3PSLIACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C RED NO. 40WZB9127XOAIACT
Sodium BenzoateOJ245FE5EUIACT
Sodium Citrate1Q73Q2JULRIACT
Saccharin SodiumSB8ZUX40TYIACT
Sorbitol506T60A25RIACT
SucroseC151H8M554IACT
Water059QF0KO0RIACT

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 Oral LiquidDIPHENHYDRAMINE HYDROCHLORIDERising Pharma Holdings, Inc.d8462e6f-a9fb-4701-97e2-d81a47f3e1962024-10-18WarningsExact identifier
ndc (package): 57237-305-12
ndc (package): 57237-305-16
ndc (product): 57237-305
ndc11 (package): 57237030516
ndc11 (package): 57237030512
spl id: 952598aa-cb50-400d-85da-e8acab206e5a
spl set id: d8462e6f-a9fb-4701-97e2-d81a47f3e196

Reported adverse events (FAERS/openFDA)#

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