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
LabelManufacturerEffective dateType
Canadian Diurex Water CapletsKobayashi Healthcare International, Inc. | Kobayashi American Manufacturing, LLC2025-05-07HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52389-349-16DiurexMax8 in 1 BLISTER PACKTABLET, FILM COATED87
52389-349-16DiurexMax2 in 1 CARTONTABLET, FILM COATED27

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52389-349DIUREX MAX (PAMABROM) TABLET, FILM COATED [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]72 package rows20250509_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 88 of 116 · 2,307 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.102ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDEAMOREPACIFIC CORPORATION531f60c9-c89a-46bc-8460-d01b2e838e6f2024-10-08WarningsExact identifier
unii: 15FIX9V2JP
AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.104OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDEAMOREPACIFIC CORPORATION60964d9f-d96c-4397-b273-6b63d18867222024-10-08WarningsExact identifier
unii: 15FIX9V2JP
IOPE AIR CUSHION Cover 21 VanillaZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDEAMOREPACIFIC CORPORATION29d6cc8d-1469-479d-a15a-e78d4e22d4a22024-10-08WarningsExact identifier
unii: 15FIX9V2JP
PrenatrylFERROUS FUMARATE, FOLIC ACIDPureTek Corporationb364551b-2ccc-4db3-e053-2995a90afbbf2024-10-08Boxed warning, Adverse reactionsExact identifier
unii: TLM2976OFR
Bio Co-Enzyme PhaseCARDUUS MARIANUS, ASCORBICUM ACIDUM, CYSTEINUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PULSATILLA (PRATENSIS), PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-KETOGLUTARICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CERIUM OXALICUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MAGNESIUM OROTICUM DIHYDRICUM, MALICUM ACIDUM, NADIDUM, NATRUM PYRUVICUM, PANTOTHENIC ACID, SUCCINICUM ACIDUM, ADRENALINUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, HEPAR SULPHURIS CALCAREUM, SULPHUR, ACONITICUM ACIDUM, CIS-,Deseret Biologicals, Inc.afad858e-064f-454d-be78-da1501ffe8532024-10-04WarningsExact identifier
unii: TLM2976OFR
Cramp TabsACETAMINOPHEN, PAMABROM, AND PYRILAMINE MALEATEJHK DBA American Safety & First Aidc090807d-03b7-42d4-be41-f6240a3b330f2024-10-04WarningsExact identifier
unii: UA8U0KJM72
DermacinRx Skin Moisturizing Ultra SPF 50 SunscreenAVOBENZONE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDEPureTek Corporation86eb06cc-d63f-4500-a52e-14ef99a565322024-10-02WarningsExact identifier
unii: 15FIX9V2JP
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD43bec652-3f2c-4671-8a0c-c4c4a4bfcc7a2024-10-01WarningsExact identifier
unii: 15FIX9V2JP
PrenatrixFERROUS FUMARATE, FOLIC ACIDPureTek Corporationae07585b-e6e4-fd6d-e053-2995a90a7eec2024-09-30Boxed warning, Adverse reactionsExact identifier
unii: TLM2976OFR
PretrateFERROUS FUMARATE, FOLIC ACIDPureTek Corporationba4a1424-0782-77c0-e053-2a95a90a6e442024-09-30Boxed warning, Adverse reactionsExact identifier
unii: TLM2976OFR
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUREnergique, Inc.87c92497-8a51-4977-87fe-e0b4c6bafb192024-09-27WarningsExact identifier
unii: 368GB5141J
Advanced Eye Relief/ Redness Maximum ReliefNAPHAZOLINE HYDROCHLORIDE AND HYPROMELLOSEBausch & Lomb Incorporated3c11285a-7e86-4b47-b1ee-e7d59858087d2024-09-25WarningsExact identifier
unii: 3NXW29V3WO
blink tearsPOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporated10fcf407-6eaf-4730-9ed0-9b7715cf57012024-09-20WarningsExact identifier
unii: B697894SGQ
Soothe XP Preservative FreeLIGHT MINERAL OIL AND MINERAL OILBausch & Lomb Incorporatedb254d885-6d49-4c95-b6be-cfdad49c85e62024-09-20WarningsExact identifier
unii: N6K5787QVP
blink gel tearsPOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporated6f7e06c3-204d-459a-af8f-c46be9ad0e8d2024-09-20WarningsExact identifier
unii: B697894SGQ
Soothe XPLIGHT MINERAL OIL AND MINERAL OILBausch & Lomb Incorporatedc0f053da-8d22-433e-a36e-79cf15ad387f2024-09-20WarningsExact identifier
unii: N6K5787QVP
DexatranMULTIVITAMINPureTek Corporatione052d2c2-7a3f-37be-e053-2a95a90af21c2024-09-13Warnings, Adverse reactionsExact identifier
unii: TLM2976OFR
DavimetMULTIVITAMINPureTek Corporatione4a57710-caa9-51e5-e053-2a95a90a8ad02024-09-13Warnings, Adverse reactionsExact identifier
unii: TLM2976OFR
Bact CombinationADENOSINUM TRIPHOSPHORICUM DINATRUM, CINNAMIC ACID, COLIBACILLINUM CUM NATRUM MURIATICUM, STREPTOCOCCUS BOVIS DNA, DYSENTERY BACILLUS, ECHINACEA (ANGUSTIFOLIA), ENTEROCOCCUS FAECALIS, HELICOBACTER PYLORI, HELICOBACTER PYLORI DNA, LEGIONELLA PNEUMOPHILA, LISTERIA MONOCYTOGENES, MALICUM ACIDUM, MYCOPLASMA PNEUMONIAE, NATRUM OXALACETICUM, OROTICUM ACIDUM, PETROSELINUM SATIVUM, PNEUMOCOCCINUM, PROTEUS (MIRABILIS), PROTEUS (MORGANI), PROTEUS (VULGARIS), RIBOFLAVINUM, PSEUDOMONAS AERUGINOSA,Deseret Biologicals, Inc.bcc7daf2-013b-4978-a33c-bb7e63039f592024-09-11WarningsExact identifier
unii: TLM2976OFR
Leader Preservative-Free Ultra Lubricating Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCardinal Health2a2aa620-ca63-4698-88fd-fc263b8fa0d12024-09-07WarningsExact identifier
unii: B697894SGQ

Reported adverse events (FAERS/openFDA)#

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