Is PEDITRACE approved by KKM / NPRA in Malaysia?

Yes, PEDITRACE is officially registered with the National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia under registration number MAL20021424ACRZ with status "PRODUCT APPROVED".

What are the generic alternatives for PEDITRACE in Malaysia?

There are 1 approved pharmaceutical formulations registered in Malaysia containing the same active ingredient (Zinc Chloride), which can be compared for cost and availability.

MAL20021424ACRZPrescription (MAL-A)

PEDITRACE

Q: What are the active ingredients of PEDITRACE?

The active ingredients of PEDITRACE as declared to NPRA are: Zinc chloride 521MG, Sodium Fluoride 126MG, COPPER CHLORIDE 53.7MG, Manganese Chloride 3.60MG, SODIUM SELENITE 6.66MG, Potassium iodide 1.31MG.

Generic Molecule: Zinc Chloride

ACTIVE & APPROVEDValid till: 28 Nov 2027

NPRA Official Regulatory Summary

PEDITRACE is a KKM-approved Prescription Medicine registered under MAL number MAL20021424ACRZ by FRESENIUS KABI MALAYSIA SDN. BHD. Its active ingredient is Zinc chloride 521MG, Sodium Fluoride 126MG, COPPER CHLORIDE 53.7MG, Manganese Chloride 3.60MG, SODIUM SELENITE 6.66MG, Potassium iodide 1.31MG, manufactured by HP Halden Pharma AS.

Holder (PRH)

FRESENIUS KABI MALAYSIA SDN. BHD

Manufacturer

HP Halden Pharma AS

First Registered

28 Nov 2022

Validity

28 Nov 2027

Prescription Required (Schedule Poison)

Need a valid doctor's prescription renewal in Malaysia?

Consult Online Doctor (Telehealth)

Active Ingredients & Strength Formulation

6 Components

Active Substance / Molecule	Declared Strength / Dosage	Generic Directory
Zinc chloride	521MG	Find Brands
Sodium Fluoride	126MG	Find Brands
COPPER CHLORIDE	53.7MG	Find Brands
Manganese Chloride	3.60MG	Find Brands
SODIUM SELENITE	6.66MG	Find Brands
Potassium iodide	1.31MG	Find Brands

Dosage values indicate declared active concentration per unit dose as registered with NPRA Malaysia.

Sole Registered Brand Formulation

This product is currently the primary or innovator formulation registered in Malaysia under Zinc Chloride.

Malaysian KKM Security Hologram Verification

FarmaChecker & Meditag™

By Malaysian Ministry of Health (KKM) regulation, all genuine registered pharmaceuticals, health supplements (MAL-N), and traditional products (MAL-T) distributed in Malaysia must feature an official tamper-evident security hologram sticker on the physical packaging.

1. Visual Tilt Check

Tilt the box under light to view the micro-engraved KKM coat of arms and multi-layer iridescent security patterns.

2. Match MAL Number

Ensure the printed MAL code matches MAL20021424ACRZ exactly on label and box.

3. FarmaChecker Scan

Scan using the official FarmaChecker app on iOS / Android to authenticate serial token with NPRA servers.

If the packaging lacks a security hologram or fails the FarmaChecker scan, do not consume and report to Cawangan Penguatkuasaan Farmasi (CPF KKM).

Frequently Asked Questions & Verification Details

Is PEDITRACE approved by KKM / NPRA?

Yes. PEDITRACE is actively registered with the National Pharmaceutical Regulatory Agency under official registration number MAL20021424ACRZ with current status PRODUCT APPROVED. Registration was filed by FRESENIUS KABI MALAYSIA SDN. BHD.

What are the active ingredients of PEDITRACE?

The declared active therapeutic components are: Zinc chloride 521MG, Sodium Fluoride 126MG, COPPER CHLORIDE 53.7MG, Manganese Chloride 3.60MG, SODIUM SELENITE 6.66MG, Potassium iodide 1.31MG. Always follow dosage recommendations prescribed by a certified doctor or licensed pharmacist.

What are the registered generic alternatives in Malaysia?

In Malaysia, there are 1 registered brand formulations containing identical active ingredients (Zinc Chloride). You can review them in the alternative brands section above or consult your community pharmacist for generic bioequivalent substitution.

Semakan status pendaftaran KKM / NPRA: PEDITRACE (MAL20021424ACRZ) | Pengganti ubat di Malaysia | Bahan aktif ubat & maklumat farmasi.