Home NDC 52389-155 Diurex
Product NDC 52389-155
11-digit product format 523890155
Labeler code 52389
Product ID 52389-155_32c05c2a-5010-0362-e063-6394a90af7cf
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 2005-09-01
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 2026-12-31
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 Ultra
Listing expiration 2026-12-31 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 52389-155-02 DiurexUltra 80 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 80 15 52389-155-02 DiurexUltra 2 in 1 PACKAGE TABLET, FILM COATED 2 15 52389-155-80 DiurexUltra 80 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 80 15 52389-155-90 DiurexUltra 1 in 1 CARTON TABLET, FILM COATED 1 15 52389-155-90 DiurexUltra 90 in 1 BOTTLE TABLET, FILM COATED 90 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Caffeine ACTIVE INGREDIENT 3G6A5W338E DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 Caffeine ACTIVE MOIETY 3G6A5W338E DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 Acacia INACTIVE INGREDIENT 5C5403N26O DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 Calcium carbonate INACTIVE INGREDIENT H0G9379FGK DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 Cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 Croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 Ethyl vanillin INACTIVE INGREDIENT YC9ST449YJ DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 FD&C Blue No. 1 INACTIVE INGREDIENT H3R47K3TBD DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 FD&C Blue No. 2 INACTIVE INGREDIENT L06K8R7DQK DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 Hypromellose INACTIVE INGREDIENT 3NXW29V3WO DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 Lactose INACTIVE INGREDIENT J2B2A4N98G DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 Magnesium silicate INACTIVE INGREDIENT 9B9691B2N9 DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 Magnesium stearate INACTIVE INGREDIENT 70097M6I30 DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 Maltodextrin INACTIVE INGREDIENT 7CVR7L4A2D DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 Polyethylene glycol 600 INACTIVE INGREDIENT NL4J9F21N9 DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 Polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 Stearic acid INACTIVE INGREDIENT 4ELV7Z65AP DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 Titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52389-155 DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.] 15 Current NDC, Legacy NDC, 5 package rows 20250416_9a035265-40c6-43f5-8de6-6bece8449840.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 52389-155-02 52389015502 2 BOTTLE, PLASTIC in 1 PACKAGE (52389-155-02) / 80 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2024-01-04 No No Current 52389-155-80 52389015580 80 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52389-155-80) 2005-09-01 0000-00-00 No No Current 52389-155-90 52389015590 1 BOTTLE in 1 CARTON (52389-155-90) / 90 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2005-09-01 0000-00-00 No No Current