FDA.reportPublic FDA data

Banophen

Manufacturer
Atlantic Biologicals Corps
Effective date
2019-09-17
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:00:30

Label at a glance#

ProductBanophen
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

take every 4 to 6 hours do not take more than 6 doses in 24 hours adults and children 12 years and over 2 - 4 teaspoonsful (25 mg to 50 mg) children 6 to under 12 years 1 - 2 teaspoonsful (12.5 mg to 25 mg) children 2 to 5 years of age do not use unless directed by a doctor children under 2 years of age do not use

Storage and handling

each teaspoonful (5 mL) contains: sodium 7 mg store at room temperature 20°-25°C (68°-77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each teaspoonful (5 mL))

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl USP 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

OTC - DO NOT USE SECTION

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, including one applied topically.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
adults and children 12 years and over2 - 4 teaspoonsful (25 mg to 50 mg)
children 6 to under 12 years1 - 2 teaspoonsful (12.5 mg to 25 mg)
children 2 to 5 years of agedo not use unless directed by a doctor
children under 2 years of agedo not use

Other information

STORAGE AND HANDLING SECTION

  • each teaspoonful (5 mL) contains: sodium 7 mg
  • store at room temperature 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

artificial cherry flavor, citric acid, D&C Red #33, FD&C Red #40, glycerin, polysorbate 20, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution

Questions or comments?

OTC - QUESTIONS SECTION

(800) 616-2471

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 17856-5174

NDC: 17856-5174-2 5 mL in a CUP

NDC: 17856-5174-1 10 mL in a CUP, UNIT-DOSE

BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1092424Banophen 12.5 MG in 5 mL Oral SolutionPSN6
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN6
1092424diphenhydramine hydrochloride 2.5 MG/ML Oral Solution [Banophen]SBD6
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD6
1092424Banophen 12.5 MG per 5 ML Oral SolutionSY6
1092424Banophen 2.5 MG/ML Oral SolutionSY6
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY6
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY6
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY6

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-5174-22021-01-29C16284748780-1ba0f9c33-51cb-a910-e053-dadaa90a0b85Banophen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-5174-2Banophen72 in 1 CASELIQUID726
17856-5174-2Banophen5 mL in 1 CUP, UNIT-DOSELIQUID56

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-5174BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [ATLANTIC BIOLOGICALS CORPS]6Legacy NDC, 2 package rows20190918_f60f923c-b2d6-4917-98cc-b0a8e3e47239.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5174-16ML - Milliliter0904-517464f0a5e7-0bdc-4c50-ab4e-1a4f91cdbee812013-02-13

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
17856-517417856-5174-2
0904-5174

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
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
Citric Acid Monohydrate2968PHW8QPIACT
Sorbitol506T60A25RIACT
FD&C Red no. 40WZB9127XOAIACT
GlycerinPDC6A3C0OXIACT
Polysorbate 207T1F30V5YHIACT
CherryBUC5I9595WIACT
Water059QF0KO0RIACT
Sodium BenzoateOJ245FE5EUIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
D&C Red no. 339DBA0SBB0LIACT

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
8b549445-7b81-4d30-b030-b508801111f8f60f923c-b2d6-4917-98cc-b0a8e3e472392019-09-17WarningsExact identifier
spl id: 8b549445-7b81-4d30-b030-b508801111f8
spl set id: f60f923c-b2d6-4917-98cc-b0a8e3e47239

Reported adverse events (FAERS/openFDA)#

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