FDA.reportPublic FDA data

Banophen

Product NDC
83112-555
Requested package NDC
83112-555-59
11-digit product format
831120555
Labeler code
83112
Product ID
83112-555_2cdbe7df-4c68-9b05-e063-6394a90a4699
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Health Department, Oklahoma State
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-01-31
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Banophen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049630Internal RxNorm lookup
1092421Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2cdbe7df-4c67-9b05-e063-6394a90a4699Available on FDA.report

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
83112-555-59Banophen1 in 1 PACKETTABLET, FILM COATED11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83112-555BANOPHEN (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [HEALTH DEPARTMENT, OKLAHOMA STATE]1Current NDC, 1 package rows20250131_2cdbe7df-4c67-9b05-e063-6394a90a4699.zip

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
BanophenDIPHENHYDRAMINE HCLHealth Department, Oklahoma State2cdbe7df-4c67-9b05-e063-6394a90a46992025-01-29Exact identifier
ndc (package): 83112-555-59
ndc (product): 83112-555
ndc11 (package): 83112055559

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092421BANOPHEN 25 MG Oral TabletPSN2cdbe7df-4c67-9b05-e063-6394a90a46991
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN2cdbe7df-4c67-9b05-e063-6394a90a46991
1092421diphenhydramine hydrochloride 25 MG Oral Tablet [Banophen]SBD2cdbe7df-4c67-9b05-e063-6394a90a46991
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD2cdbe7df-4c67-9b05-e063-6394a90a46991
1092421Banophen 25 MG Oral TabletSY2cdbe7df-4c67-9b05-e063-6394a90a46991

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83112-555-59831120555591 TABLET, FILM COATED in 1 PACKET (83112-555-59) 2025-01-31NoNoCurrent