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Diurex

Canadian Diurex Water Caplets

Approved
Approval ID

874aa629-1330-0c30-e053-2a95a90ac888

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 7, 2025

Manufacturers
FDA

Kobayashi Healthcare International, Inc.

DUNS: 156391729

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Pamabrom

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code52389-349
Product Classification
G
Generic Name
Pamabrom
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2025
FDA Product Classification

INGREDIENTS (15)

HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POTASSIUM GLUCONATEInactive
Code: 12H3K5QKN9
Classification: IACT
RIBOFLAVINInactive
Code: TLM2976OFR
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PAMABROMActive
Quantity: 50 mg in 1 1
Code: UA8U0KJM72
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
CALCIUM SULFATE DIHYDRATEInactive
Code: 4846Q921YM
Classification: IACT

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Diurex - FDA Drug Approval Details