FDA.reportPublic FDA data

OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution

Manufacturer
MEDWISE LIFESCIENCES INC.
Effective date
2025-10-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:37:58

Label at a glance#

ProductOneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure15 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

mL = milliliter take every 4 to 6 hours or as directed by a doctor do not take more than 6 doses (6 sachets) in 24 hours follow the instruction given on this carton for your easy use Age (years) Dose (mL) Children under 2 Years do not use Children 2 to 5 Years do not use unless directed by doctor Children 6 to 11 Years 1 Sachet (5 mL) to 2 Sachets (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 SECTION

Warnings

OTC - DO NOT USE SECTION

Do not use

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if the child has

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers.

OTC - WHEN USING SECTION

When using this product

  • 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

  • mL = milliliter
  • take every 4 to 6 hours or as directed by a doctor
  • do not take more than 6 doses (6 sachets) in 24 hours
  • follow the instruction given on this carton for your easy use
Age (years)Dose (mL)
Children under 2 Yearsdo not use
Children 2 to 5 Yearsdo not use unless directed by doctor
Children 6 to 11 Years1 Sachet (5 mL) to 2 Sachets (10 mL)

Other Information

OTHER SAFETY INFORMATION

  • store between 20-25°C (68-77°F)
  • Do not use if carton or sachet is torn, broken or punctured.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Sorbitol, sodium benzoate, sucralose, citric acid anhydrous, sodium citrate, flavor, xanthan gum, glycerin, sodium saccharin, sodium EDTA, water.

Question or comments?

OTC - QUESTIONS SECTION

call 1-516-675-8915

RECENT MAJOR CHANGES SECTION

Addition of picture

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 87078-411-52NDC 87078-411-52

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850078212009GTIN-13: 0850078212009
EAN-13: 0850078212009
GTIN-12: 850078212009
UPC-A: 850078212009
GTIN storage (14 digits): 00850078212009		Diphenhydramine Bubble Gum Liquid Sachet-5 ml Carton_CC.jpg

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
87078-411-52OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution12 in 1 CARTONSOLUTION121
87078-411-52OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution5 mL in 1 POUCHSOLUTION51

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87078-41187078-411-52

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
EDETATE DISODIUM7FLD91C86KIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
SUCRALOSE96K6UQ3ZD4IACT
SODIUM SACCHARINSB8ZUX40TYIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL SOLUTION8KW3E207O2IACT
SODIUM CITRATE1Q73Q2JULRIACT
XANTHAN GUMTTV12P4NEEIACT
GLYCERINPDC6A3C0OXIACT

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
OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral SolutionDIPHENHYDRAMINE HCLMEDWISE LIFESCIENCES INC.407b7cbb-7ebd-7b7e-e063-6394a90af5012025-10-06WarningsExact identifier
ndc (package): 87078-411-52
ndc (product): 87078-411
ndc11 (package): 87078041152
spl id: 407b7cbb-7ebe-7b7e-e063-6394a90af501
spl set id: 407b7cbb-7ebd-7b7e-e063-6394a90af501

Reported adverse events (FAERS/openFDA)#

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