Home NDC 52389-306 Diurex
Product NDC 52389-306
11-digit product format 523890306
Labeler code 52389
Product ID 52389-306_32732994-0e5d-93a9-e063-6394a90a9c50
Type HUMAN OTC DRUG
Nonproprietary name Caffeine, magnesium salicylate
Dosage form TABLET, COATED
Route ORAL
Labeler Kobayashi Healthcare International, Inc.
Application M027
Marketing category OTC MONOGRAPH DRUG
Marketing start 2005-05-15
Substance MAGNESIUM SALICYLATE; CAFFEINE
Active strength 162.5; 50 mg/1; 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 Water Pills
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MAGNESIUM SALICYLATE 162.5 mg/1 CAFFEINE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 41728CY7UX Internal UNII lookup 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 1001437 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 52389-306-01 DiurexWater Pills 42 in 1 BLISTER PACK TABLET, COATED 42 13 52389-306-02 DiurexWater Pills 11 in 1 BLISTER PACK TABLET, COATED 11 13 52389-306-21 DiurexWater Pills 2 in 1 CARTON TABLET, COATED 2 13 52389-306-21 DiurexWater Pills 21 in 1 BLISTER PACK TABLET, COATED 21 13 52389-306-22 DiurexWater Pills 2 in 1 CARTON TABLET, COATED 2 13 52389-306-36 DiurexWater Pills 2 in 1 CARTON TABLET, COATED 2 13 52389-306-36 DiurexWater Pills 18 in 1 BLISTER PACK TABLET, COATED 18 13 52389-306-42 DiurexWater Pills 1 in 1 CARTON TABLET, COATED 1 13 52389-306-84 DiurexWater Pills 2 in 1 CARTON TABLET, COATED 2 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Caffeine ACTIVE INGREDIENT 3G6A5W338E DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 2 Magnesium salicylate ACTIVE INGREDIENT 41728CY7UX DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 2 Caffeine ACTIVE MOIETY 3G6A5W338E DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 2 SALICYLIC ACID ACTIVE MOIETY O414PZ4LPZ DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 2 Acacia INACTIVE INGREDIENT 5C5403N26O DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 2 Calcium carbonate INACTIVE INGREDIENT H0G9379FGK DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 2 Cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 2 Crospovidone INACTIVE INGREDIENT 68401960MK DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 2 FD&C Blue No. 1 INACTIVE INGREDIENT H3R47K3TBD DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 2 Hypromelloses INACTIVE INGREDIENT 3NXW29V3WO DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 2 Magnesium stearate INACTIVE INGREDIENT 70097M6I30 DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 2 Maltodextrin INACTIVE INGREDIENT 7CVR7L4A2D DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 2 Methylene blue INACTIVE INGREDIENT T42P99266K DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 2 Mineral oil INACTIVE INGREDIENT T5L8T28FGP DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 2 Polyethylene glycol 600 INACTIVE INGREDIENT NL4J9F21N9 DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 2 Polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 2 Shellac INACTIVE INGREDIENT 46N107B71O DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 2 Silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 2 Sodium starch glycolate type A potato INACTIVE INGREDIENT 5856J3G2A2 DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 2 Starch, corn INACTIVE INGREDIENT O8232NY3SJ DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 2 Stearic acid INACTIVE INGREDIENT 4ELV7Z65AP DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 2 Talc INACTIVE INGREDIENT 7SEV7J4R1U DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 2 Titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 2 Triacetin INACTIVE INGREDIENT XHX3C3X673 DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52389-306 DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.] 13 Current NDC, Legacy NDC, 9 package rows 20250412_e02a39f9-1c8c-4d38-b394-3f5b7062932c.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 52389-306-01 52389030601 42 in 1 BLISTER PACK Historical 52389-306-02 52389030602 11 in 1 BLISTER PACK Historical 52389-306-21 52389030621 2 in 1 CARTON Historical 52389-306-22 52389030622 2 in 1 CARTON Historical 52389-306-36 52389030636 2 BLISTER PACK in 1 CARTON (52389-306-36) / 18 TABLET, COATED in 1 BLISTER PACK 2 blister pack 2020-02-14 0000-00-00 No No Current 52389-306-42 52389030642 1 BLISTER PACK in 1 CARTON (52389-306-42) / 42 TABLET, COATED in 1 BLISTER PACK (52389-306-01) 1 blister pack 2005-05-15 0000-00-00 No No Current 52389-306-84 52389030684 2 BLISTER PACK in 1 CARTON (52389-306-84) / 42 TABLET, COATED in 1 BLISTER PACK (52389-306-01) 2 blister pack 2012-05-02 0000-00-00 No No Current