Is Hismile Pty Ltd FDA approved?

Hismile Pty Ltd holds no registered establishment of its own; 28 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Hismile Pty Ltd make?

28 products are listed under Hismile Pty Ltd in the openFDA NDC Directory, most often as gel; gel, dentifrice. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Hismile Pty Ltd

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

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Registered sites: 0
Active NDC listings: 28
Labeller names: 2
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

28 active NDC listings: 28 human otc drug. By marketing category: OTC MONOGRAPH DRUG 28.

Dosage form	NDCs
gel	27
gel, dentifrice	1

Route	NDCs
dental	20
topical	5
oral	3

Labeller name on the listing	NDCs
hismile pty ltd	14
hismile pty ltd	14

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Blue Raspberry Flavor Sodium Fluoride Anticavity Toothpast	Sodium Fluoride	gel, dental	83013-341OTC MONOGRAPH DRUG
Classic Mint Flavor Sodium Fluoride Anticavity Toothpast	Sodium Fluoride	gel, topical	83013-340OTC MONOGRAPH DRUG
Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpast	Sodium Fluoride	gel, topical	83013-338OTC MONOGRAPH DRUG
HISMILE	Sodium Fluoride	gel, dental	83013-321OTC MONOGRAPH DRUG
HISMILE	Sodium Fluoride	gel, dental	83013-322OTC MONOGRAPH DRUG
HISMILE	Sodium Fluoride	gel, dental	83013-323OTC MONOGRAPH DRUG
HISMILE	Sodium Fluoride	gel, dental	83013-325OTC MONOGRAPH DRUG
HISMILE	Sodium Fluoride	gel, dental	83013-326OTC MONOGRAPH DRUG
Hismile	Peach Iced Tea Flavor Sodium Fluoride Anticavity Toothpaste	gel, dental	83013-311OTC MONOGRAPH DRUG
Hismile	Coconut Whip Flavor Sodium Fluoride Anticavity Toothpaste	gel, dental	83013-312OTC MONOGRAPH DRUG
Hismile	Mango Sorbet Flavor Sodium Fluoride Anticavity Toothpaste	gel, dental	83013-313OTC MONOGRAPH DRUG
Hismile	Smooth Mint Flavor Sodium Fluoride Anticavity Toothpaste	gel, dental	83013-314OTC MONOGRAPH DRUG
Hismile	Watermelon Flavor Sodium Fluoride Anticavity Toothpaste	gel, dental	83013-315OTC MONOGRAPH DRUG
Hismile	Red Velvet Flavor Sodium Fluoride Anticavity Toothpaste	gel, dental	83013-316OTC MONOGRAPH DRUG
Hismile	Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpaste	gel, dental	83013-317OTC MONOGRAPH DRUG
Hismile	Strawberry Flavor Sodium Fluoride Anticavity Toothpaste	gel, dental	83013-318OTC MONOGRAPH DRUG
Hismile	Banana Flavor Sodium Fluoride Anticavity Toothpaste	gel, dental	83013-319OTC MONOGRAPH DRUG
Hismile	Vanilla Flavor Sodium Fluoride Anticavity Toothpaste	gel, dental	83013-320OTC MONOGRAPH DRUG
Hismile	Candy Cane Flavor Sodium Fluoride Anticavity Toothpaste	gel, dental	83013-327OTC MONOGRAPH DRUG
Hismile	Magically Delicious Flavor Sodium Fluoride Anticavity Toothpaste	gel, dentifrice, dental	83013-335OTC MONOGRAPH DRUG
Hismile Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpast	Sodium fluoride	gel, oral	83013-331OTC MONOGRAPH DRUG
Hismile Miffy Sweet Apple Flavor Sodium Fluoride Anticavity Toothpast	sodium fluoride	gel, oral	83013-333OTC MONOGRAPH DRUG
Hismile Pink Lemonade Sodium Fluoride Anticavity Toothpast	sodium fluoride	gel, oral	83013-332OTC MONOGRAPH DRUG
Ice Pop Flavor Sodium Fluoride Anticavity Toothpast	Sodium Fluoride	gel, dental	83013-328OTC MONOGRAPH DRUG
Strawberry Flavor Sodium Fluoride Anticavity Toothpast	Sodium Fluoride	gel, topical	83013-339OTC MONOGRAPH DRUG
The Simpsons Pink Donut Flavor Sodium Fluoride Anticavity Toothpast	Sodium Fluoride	gel, topical	83013-344OTC MONOGRAPH DRUG
The Simpsons Purple Squishee Flavor Sodium Fluoride Anticavity Toothpast	Sodium Fluoride	gel, dental	83013-346OTC MONOGRAPH DRUG
Watermelon Flavor Sodium Fluoride Anticavity Toothpast	Sodium Fluoride	gel, topical	83013-337OTC MONOGRAPH DRUG

Compare

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Enquiry

Common questions

Is Hismile Pty Ltd FDA approved?: Hismile Pty Ltd holds no registered establishment of its own; 28 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Hismile Pty Ltd make?: 28 products are listed under Hismile Pty Ltd in the openFDA NDC Directory, most often as gel; gel, 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.