Is ROROBELL FDA approved?

ROROBELL holds no registered establishment of its own; 5 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does ROROBELL make?

5 products are listed under ROROBELL in the openFDA NDC Directory, most often as paste, dentifrice. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

ROROBELL

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

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Registered sites: 0
Active NDC listings: 5
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

5 active NDC listings: 5 human otc drug. By marketing category: UNAPPROVED DRUG OTHER 4, OTC MONOGRAPH DRUG 1.

Dosage form	NDCs
paste, dentifrice	5

Route	NDCs
oral	5

Labeller name on the listing	NDCs
rorobell	5

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
ROROBELL WAWA Gum Care Tooth	Hydrated Silica, Sodium Fluoride, Tocopheryl Acetate	paste, dentifrice, oral	81275-011UNAPPROVED DRUG OTHER
ROROBELL WAWA Kids Tooth Natural Green Grape Flavor	Hydrated Silica, Sodium Fluoride, Tocopheryl Acetate	paste, dentifrice, oral	81275-015UNAPPROVED DRUG OTHER
ROROBELL WAWA Sensitive Teeth Tooth	Hydrated Silica, Potassium Nitrate, Sodium Fluoride	paste, dentifrice, oral	81275-014UNAPPROVED DRUG OTHER
ROROBELL WAWA Whitening Tooth	Silica, Hydrogen Peroxide, Tocopheryl Acetate	paste, dentifrice, oral	81275-013UNAPPROVED DRUG OTHER
Rorobell WaWa Tooth	Sodium Monofluorophosphate	paste, dentifrice, oral	81275-010OTC MONOGRAPH DRUG

Enquiry

Common questions

Is ROROBELL FDA approved?: ROROBELL holds no registered establishment of its own; 5 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does ROROBELL make?: 5 products are listed under ROROBELL in the openFDA NDC Directory, most often as paste, dentifrice. 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.