Home NDC 71205-611 Banophen
Product NDC 71205-611
11-digit product format 712050611
Labeler code 71205
Product ID 71205-611_449c7ca6-7fd4-4728-b330-2a3e261c6693
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Proficient Rx LP
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 1990-03-02
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 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Banophen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TC2D6JAD40 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049630 Internal RxNorm lookup 1092421 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71205-611-20 Banophen 20 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 20 3 71205-611-30 Banophen 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 3 71205-611-60 Banophen 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 3 71205-611-90 Banophen 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71205-611 BANOPHEN (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [PROFICIENT RX LP] 3 Current NDC, Legacy NDC, 4 package rows 20231212_62934d0f-b23d-4c03-9d60-a7bad41f9b42.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 73 of 178 · 3,550 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 71205-611-20 71205061120 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-611-20) 2021-10-11 0000-00-00 No No Current 71205-611-30 71205061130 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-611-30) 2021-10-11 0000-00-00 No No Current 71205-611-60 71205061160 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-611-60) 2021-10-11 0000-00-00 No No Current 71205-611-90 71205061190 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-611-90) 2021-10-11 0000-00-00 No No Current