Is Dead Sea Periclase FDA approved?

Dead Sea Periclase holds 1 FDA-registered establishment in Israel. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are Dead Sea Periclase's drugs manufactured?

The FDA register lists ROTEM - MISHOR. Registered operations: active ingredient (API) manufacture.

What drugs does Dead Sea Periclase make?

8 products are listed under Dead Sea Periclase in the openFDA NDC Directory, most often as powder; granule. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Dead Sea Periclase

Data as of 28 Sept 2026 · How to read this entry

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Registered sites: 1
Active NDC listings: 8
Labeller names: 3
Live patents: 0
Countries: 1
Base: Israel

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Dead Sea Periclase	Mobile Post Arava, ROTEM - MISHOR, 8680600, Israel (ISR)	Active ingredient (API) manufacture	3000121060625912417

Catalogue

Drug listings by form and route

8 active NDC listings: 8 bulk ingredient. By marketing category: BULK INGREDIENT 8.

Dosage form	NDCs
powder	7
granule	1

Route	NDCs

Labeller name on the listing	NDCs
dead sea periclase	6
dead sea periclase	1
dead sea periclase ltd	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	MAGNESIUM HYDROXIDE	powder	50917-840BULK INGREDIENT
-	MAGNESIUM OXIDE	powder	50917-857BULK INGREDIENT
-	MAGNESIUM OXIDE	powder	50917-867BULK INGREDIENT
-	MAGNESIUM OXIDE	granule	50917-877BULK INGREDIENT
-	MAGNESIUM OXIDE	powder	50917-887BULK INGREDIENT
-	Magnesium Carbonate	powder	50917-853BULK INGREDIENT
-	Magnesium Carbonate	powder	50917-897BULK INGREDIENT
-	Magnesium Oxide	powder	50917-837BULK INGREDIENT

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Enquiry

Common questions

Is Dead Sea Periclase FDA approved?: Dead Sea Periclase holds 1 FDA-registered establishment in Israel. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Dead Sea Periclase's drugs manufactured?: The FDA register lists ROTEM - MISHOR. Registered operations: active ingredient (API) manufacture.
What drugs does Dead Sea Periclase make?: 8 products are listed under Dead Sea Periclase in the openFDA NDC Directory, most often as powder; granule. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.