Home NDC 0904-7672 Banophen
Product NDC 0904-7672
11-digit product format 009047672
Labeler code 0904
Product ID 0904-7672_3a7e89bb-8a02-4fe1-9fd9-821f403a10b3
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Major Pharmaceuticals
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-10-15
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 1049909 Internal RxNorm lookup 1092422 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 70 of 174 · 3,464 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0904-7672-24 00904767224 24 BLISTER PACK in 1 CARTON (0904-7672-24) / 1 CAPSULE in 1 BLISTER PACK 24 blister pack 2026-10-15 No No Current 0904-7672-60 00904767260 100 CAPSULE in 1 BOTTLE (0904-7672-60) 100 capsule 2026-10-15 No No Current 0904-7672-61 00904767261 100 BLISTER PACK in 1 CARTON (0904-7672-61) / 1 CAPSULE in 1 BLISTER PACK 100 blister pack 2026-10-15 No No Current 0904-7672-80 00904767280 1000 CAPSULE in 1 BOTTLE (0904-7672-80) 1000 capsule 2026-10-15 No No Current