Home NDC 52389-249 Diurex
Product NDC 52389-249
11-digit product format 523890249
Labeler code 52389
Product ID 52389-249_3287c676-c9cc-273e-e063-6294a90a9c9b
Type HUMAN OTC DRUG
Nonproprietary name Pamabrom
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Kobayashi Healthcare International, Inc.
Application M027
Marketing category OTC MONOGRAPH DRUG
Marketing start 1995-12-20
Substance PAMABROM
Active strength 50 mg/1
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 · 36 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 Max
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PAMABROM 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination UA8U0KJM72 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199158 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52389-249-10 DiurexMax 4 in 1 CARTON TABLET, FILM COATED 4 14 52389-249-10 DiurexMax 10 in 1 BLISTER PACK TABLET, FILM COATED 10 14 52389-249-16 DiurexMax 2 in 1 CARTON TABLET, FILM COATED 2 14 52389-249-16 DiurexMax 8 in 1 BLISTER PACK TABLET, FILM COATED 8 14 52389-249-20 DiurexMax 30 in 1 BLISTER PACK TABLET, FILM COATED 30 14 52389-249-20 DiurexMax 1 in 1 CARTON TABLET, FILM COATED 1 14 52389-249-24 DiurexMax 1 in 1 CARTON TABLET, FILM COATED 1 14 52389-249-24 DiurexMax 24 in 1 BLISTER PACK TABLET, FILM COATED 24 14 52389-249-30 DiurexMax 10 in 1 BLISTER PACK TABLET, FILM COATED 10 14 52389-249-30 DiurexMax 3 in 1 CARTON TABLET, FILM COATED 3 14 52389-249-40 DiurexMax 1 in 1 CARTON TABLET, FILM COATED 1 14 52389-249-40 DiurexMax 40 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 40 14 52389-249-48 DiurexMax 24 in 1 BLISTER PACK TABLET, FILM COATED 24 14 52389-249-48 DiurexMax 2 in 1 CARTON TABLET, FILM COATED 2 14 52389-249-50 DiurexMax 10 in 1 BLISTER PACK TABLET, FILM COATED 10 14 52389-249-50 DiurexMax 5 in 1 CARTON TABLET, FILM COATED 5 14 52389-249-72 DiurexMax 3 in 1 CARTON TABLET, FILM COATED 3 14 52389-249-72 DiurexMax 24 in 1 BLISTER PACK TABLET, FILM COATED 24 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Pamabrom ACTIVE INGREDIENT UA8U0KJM72 DIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 2 Pamabrom ACTIVE MOIETY UA8U0KJM72 DIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 2 Calcium sulfate dihydrate INACTIVE INGREDIENT 4846Q921YM DIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 2 Croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 DIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 2 DIBASIC CALCIUM PHOSPHATE DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP DIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 2 FD&C Blue No. 1 INACTIVE INGREDIENT H3R47K3TBD DIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 2 Hypromellose INACTIVE INGREDIENT 3NXW29V3WO DIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 2 Magnesium stearate INACTIVE INGREDIENT 70097M6I30 DIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 2 Mineral oil INACTIVE INGREDIENT T5L8T28FGP DIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 2 Polyethylene glycol 400 INACTIVE INGREDIENT B697894SGQ DIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 2 Potassium gluconate INACTIVE INGREDIENT 12H3K5QKN9 DIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 2 Riboflavin INACTIVE INGREDIENT TLM2976OFR DIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 2 Sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J DIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 2 Stearic acid INACTIVE INGREDIENT 4ELV7Z65AP DIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] 2 Titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP DIUREX MAX (PAMABROM) TABLET, FILM 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 52389-249 DIUREX MAX (PAMABROM) TABLET, FILM COATED [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.] 14 Current NDC, Legacy NDC, 18 package rows 20250413_37dfece3-d570-4ab2-ba95-af6eb1f3acd4.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 52389-249-10 52389024910 4 BLISTER PACK in 1 CARTON (52389-249-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK 4 blister pack 2017-11-10 0000-00-00 No No Current 52389-249-16 52389024916 2 in 1 CARTON Historical 52389-249-20 52389024920 30 in 1 BLISTER PACK Historical 52389-249-24 52389024924 1 BLISTER PACK in 1 CARTON (52389-249-24) / 24 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2011-04-18 0000-00-00 No No Current 52389-249-30 52389024930 3 BLISTER PACK in 1 CARTON (52389-249-30) / 10 TABLET, FILM COATED in 1 BLISTER PACK 3 blister pack 2021-07-12 0000-00-00 No No Current 52389-249-40 52389024940 1 in 1 CARTON Historical 52389-249-48 52389024948 2 BLISTER PACK in 1 CARTON (52389-249-48) / 24 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2013-07-18 0000-00-00 No No Current 52389-249-50 52389024950 5 BLISTER PACK in 1 CARTON (52389-249-50) / 10 TABLET, FILM COATED in 1 BLISTER PACK 5 blister pack 2022-07-18 0000-00-00 No No Current 52389-249-72 52389024972 3 BLISTER PACK in 1 CARTON (52389-249-72) / 24 TABLET, FILM COATED in 1 BLISTER PACK 3 blister pack 2018-06-12 0000-00-00 No No Current