NDC 52389-349 - Diurex Max

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 52389-349
Package NDCs from labels: 52389-349-16
Manufacturer: Kobayashi Healthcare International, Inc. | Kobayashi American Manufacturing, LLC
Effective date: 2025-05-07
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Canadian Diurex Water Caplets	Kobayashi Healthcare International, Inc. \| Kobayashi American Manufacturing, LLC	2025-05-07	HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52389-349-16	DiurexMax	8 in 1 BLISTER PACK	TABLET, FILM COATED	8		7
52389-349-16	DiurexMax	2 in 1 CARTON	TABLET, FILM COATED	2		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52389-349	DIUREX MAX (PAMABROM) TABLET, FILM COATED [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]	7	2 package rows	20250509_874aa629-1330-0c30-e053-2a95a90ac888.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 116 of 116 · 2,307 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Age Renewal Firming	OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE	AMCOL Health & Beauty Solutions, Inc. DBA	6cb27f87-40a3-4049-aded-eb788509c575	2016-10-07	Warnings	Exact identifier unii: 15FIX9V2JP
Nuance Salma Hayek Renewed Radiance Brightening BB Cream Broad Spectrum SPF 30 Sunscreen	NUANCE SALMA HAYEK RENEWED RADIANCE BRIGHTENING BB CREAM BROAD SPECTRUM SPF 30 SUNSCREEN	Mana Products	d0e00d97-dbf4-46af-aeda-bdfd6f49b5ab	2016-09-08	Warnings	Exact identifier unii: 15FIX9V2JP
Meijer Kids Tear Free SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Meijer Distribution, Inc.	7415511e-1ecf-4646-b64b-267fbf7d116b	2016-06-02	Warnings	Exact identifier unii: 15FIX9V2JP
Meijer Baby Tear Free SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Meijer Distributing Inc.	2434de23-bcc9-4a83-9945-16fc3f2b8c61	2016-06-01	Warnings	Exact identifier unii: 15FIX9V2JP
TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 34 Sunscreen (Tinted)	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE AND ZINC OXIDE	Allergan, Inc.	6a996e03-907f-4e6a-b232-0892b86956b0	2015-08-21	Warnings	Exact identifier unii: 15FIX9V2JP
Renewal Firming Day Broad Spectrum SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	BURT'S BEES, INC.	18ceb5d8-4b76-6a54-e054-00144ff88e88	2015-06-18	Warnings	Exact identifier unii: 15FIX9V2JP
TiZO2	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD.	30468afc-9616-4765-b046-12e97a0a7827	2010-12-20	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.