Home NDC 52389-656 Diurex
Product NDC 52389-656
11-digit product format 523890656
Labeler code 52389
Product ID 52389-656_53c43c3f-7dd9-4887-e063-6294a90a0db4
Type HUMAN OTC DRUG
Nonproprietary name Caffeine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Kobayashi Healthcare International, Inc.
Application M027
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-10-31
Substance CAFFEINE
Active strength 100 mg/1
Pharmacologic classes Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
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 Diurex
Brand name suffix Ultimate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CAFFEINE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3G6A5W338E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308853 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 52389-656-01 DiurexUltimate 30 in 1 BLISTER PACK TABLET, FILM COATED 30 12 52389-656-60 DiurexUltimate 2 in 1 CARTON TABLET, FILM COATED 2 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52389-656 DIUREX ULTIMATE (CAFFEINE) TABLET, FILM COATED [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.] 12 Current NDC, Legacy NDC, 2 package rows 20250416_c6debbfe-6061-463f-8f17-fb240c6f1bab.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 3 of 3 · 43 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 52389-656-01 52389065601 30 in 1 BLISTER PACK Historical 52389-656-60 52389065660 2 BLISTER PACK in 1 CARTON (52389-656-60) / 30 TABLET, FILM COATED in 1 BLISTER PACK (52389-656-01) 2 blister pack 2015-10-31 0000-00-00 No No Current