Is MONOGLOT HOLDINGS Inc. FDA approved?

MONOGLOT HOLDINGS Inc. holds no registered establishment of its own; 2 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does MONOGLOT HOLDINGS Inc. make?

2 products are listed under MONOGLOT HOLDINGS Inc. in the openFDA NDC Directory, most often as cream. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

MONOGLOT HOLDINGS Inc.

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

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Registered sites: 0
Active NDC listings: 2
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

2 active NDC listings: 2 human otc drug. By marketing category: OTC MONOGRAPH DRUG 2.

Dosage form	NDCs
cream	2

Route	NDCs
topical	2

Labeller name on the listing	NDCs
monoglot holdings inc.	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
ELROEL Pang Pang Sun Cushion Plus	Zinc Oxide, Titanium Dioxide, Octinoxate, Octisalate	cream, topical	83154-004OTC MONOGRAPH DRUG
ELROEL Pang Pang Sun Cushion S7	Zinc Oxide, Titanium Dioxide, Octinoxate, Octisalate	cream, topical	83154-003OTC MONOGRAPH DRUG

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Other companies listing zinc oxide, titanium dioxide, octinoxate, octisalate

Have & Be Co., Ltd.0 sites · 18 NDC

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Common questions

Is MONOGLOT HOLDINGS Inc. FDA approved?: MONOGLOT HOLDINGS Inc. holds no registered establishment of its own; 2 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does MONOGLOT HOLDINGS Inc. make?: 2 products are listed under MONOGLOT HOLDINGS Inc. in the openFDA NDC Directory, most often as cream. 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.