Is Primal Elements FDA approved?

Primal Elements holds no registered establishment of its own; 3 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Primal Elements make?

3 products are listed under Primal Elements in the openFDA NDC Directory, most often as shampoo; gel. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Primal Elements

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 0
Active NDC listings: 3
Labeller names: 2
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

3 active NDC listings: 3 human otc drug. By marketing category: OTC MONOGRAPH DRUG 3.

Dosage form	NDCs
shampoo	2
gel	1

Route	NDCs
topical	3

Labeller name on the listing	NDCs
primal elements	2
primal elements	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
ARCTIC ICE	MENTHOL	gel, topical	80801-105OTC MONOGRAPH DRUG
DANDRUFF	pyrithione zinc	shampoo, topical	80801-103OTC MONOGRAPH DRUG
URBAN WASH DANDRUFF	pyrithione zinc	shampoo, topical	80801-101OTC MONOGRAPH DRUG

Compare

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Common questions

Is Primal Elements FDA approved?: Primal Elements holds no registered establishment of its own; 3 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Primal Elements make?: 3 products are listed under Primal Elements in the openFDA NDC Directory, most often as shampoo; gel. 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.