FDA.reportPublic FDA data

Banophen

Manufacturer
Proficient Rx LP
Effective date
2023-12-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:03:53

Label at a glance#

ProductBanophen
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: o runny nose o itchy, watery eyes o sneezing o itching of the nose or throat • temporarily relieves these symptoms due to the common cold: o runny nose o sneezing 

Dosage and administration

• do not take more than directed • take every 4 to 6 hours, or as directed by a doctor • do not take more than 6 times in 24 hours adults and children 12 years and over 1 to 2 tablets children 6 to under 12 years 1 tablet children under 6 years do not use

Storage and handling

• each tablet contains: calcium 30 mg • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) • protect from moisture • see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 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
    • itchy, watery eyes
    • sneezing
    • 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

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

  • marked drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution 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

  • do not take more than directed
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times in 24 hours

adults and children 12
years and over

1 to 2 tablets

children 6 to under 12
years

1 tablet

children under 6 years

do not use

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 30 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from moisture
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

(800)-616-2471

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71205-611-20

Compare to the active ingredient in Benadryl® Allergy ULTRATAB® Tablets*

Banophen
Diphenhydramine HCl
25 mg
Antihistamine / Allergy Relief

Relieves
Sneezing,  Runny Nose,
Itchy Throat and
Itchy, Watery Eyes

Actual Size

20 Minitabs

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl® Allergy ULTRATAB® Tablets.
50844    REV1220M32908

Rev. 03/21   M-17   Re-order No. 250050

Distributed by:
MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 USA

Repackaged by:
PROFICIENT RX LP
Thousand Oaks, CA 91320

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

71205-611-20
71205-611-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1092421BANOPHEN 25 MG Oral TabletPSN3
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN3
1092421diphenhydramine hydrochloride 25 MG Oral Tablet [Banophen]SBD3
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD3
1092421Banophen 25 MG Oral TabletSY3

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
71205-611-20Banophen20 in 1 BOTTLE, PLASTICTABLET, FILM COATED203
71205-611-30Banophen30 in 1 BOTTLE, PLASTICTABLET, FILM COATED303
71205-611-60Banophen60 in 1 BOTTLE, PLASTICTABLET, FILM COATED603
71205-611-90Banophen90 in 1 BOTTLE, PLASTICTABLET, FILM COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-611BANOPHEN (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [PROFICIENT RX LP]3Current NDC, Legacy NDC, 4 package rows20231212_62934d0f-b23d-4c03-9d60-a7bad41f9b42.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5551-24EA - Each0904-5551805dcd85-34b6-4a0a-9406-d46680925db812012-07-24
0904-5551-59EA - Each0904-55516037c229-d392-48f1-bbd8-febe968f67a312012-07-24

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
71205-61171205-611-20, 71205-611-30, 71205-611-60, 71205-611-90
0904-5551

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
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
MAGNESIUM STEARATE70097M6I30IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
STARCH, CORNO8232NY3SJIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
TALC7SEV7J4R1UIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BanophenDIPHENHYDRAMINE HCLMajor Pharmaceuticals69b7f7ca-7a3a-4fe6-a9bb-90b0e6ad62c12025-10-27WarningsExact identifier
ndc (product): 0904-5551
BanophenDIPHENHYDRAMINE HCLProficient Rx LP62934d0f-b23d-4c03-9d60-a7bad41f9b422023-12-01WarningsExact identifier
ndc (package): 71205-611-30
ndc (package): 71205-611-60
ndc (package): 71205-611-20
ndc (package): 71205-611-90
ndc (product): 71205-611
ndc11 (package): 71205061190
ndc11 (package): 71205061120
ndc11 (package): 71205061130
ndc11 (package): 71205061160
spl id: 449c7ca6-7fd4-4728-b330-2a3e261c6693
spl set id: 62934d0f-b23d-4c03-9d60-a7bad41f9b42

Reported adverse events (FAERS/openFDA)#

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