Labeler · US market

Hismile Pty Ltd

Hismile Pty Ltd is a US drug labeler with US FDA registrations covering 15 drug concepts (15 currently active) across 28 packages. It is currently the only active US supplier of 13 drugs.

ACTIVE — US

openFDA · updated weekly

Labeler codes83013

Active drugs15

Registrations28 active / 28

Packages28

Sole supplier of13 drugs

Portfolio15 drugs · US

Every drug concept this labeler has US registrations for, by package count.

Drug	Type	NDCs	Packages	Status
Sodium Fluoride gel	rx	8	8	SUPPLYING
Sodium Fluoride gel	otc	5	5	SUPPLYING
Sodium Fluoride gel	rx	3	3	SUPPLYING
Magically Delicious Flavor Sodium Fluoride Anticavity Toothpaste gel, dentifrice	otc	1	1	SUPPLYING
Watermelon Flavor Sodium Fluoride Anticavity Toothpaste gel	otc	1	1	SUPPLYING
Peach Iced Tea Flavor Sodium Fluoride Anticavity Toothpaste gel	otc	1	1	SUPPLYING
Red Velvet Flavor Sodium Fluoride Anticavity Toothpaste gel	otc	1	1	SUPPLYING
Smooth Mint Flavor Sodium Fluoride Anticavity Toothpaste gel	otc	1	1	SUPPLYING
Coconut Whip Flavor Sodium Fluoride Anticavity Toothpaste gel	otc	1	1	SUPPLYING
Strawberry Flavor Sodium Fluoride Anticavity Toothpaste gel	otc	1	1	SUPPLYING
Banana Flavor Sodium Fluoride Anticavity Toothpaste gel	otc	1	1	SUPPLYING
Candy Cane Flavor Sodium Fluoride Anticavity Toothpaste gel	otc	1	1	SUPPLYING
Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpaste gel	otc	1	1	SUPPLYING
Mango Sorbet Flavor Sodium Fluoride Anticavity Toothpaste gel	otc	1	1	SUPPLYING
Vanilla Flavor Sodium Fluoride Anticavity Toothpaste gel	otc	1	1	SUPPLYING

Sole US supplier

Drugs where this labeler is currently the only active US supplier — a single point of failure if it exits.

+3 more

At a glance

TypeLabeler
Labeler codes83013
Filing names1
Drugs (active)15
Drugs (all time)15
US registrations28
Packages28

Watch this company

Alerts for recalls, exits, and new registrations.

Facility locations, FDA inspections, and parent-company mapping are on the roadmap. Name variants reported to FDA under different spellings are merged into this profile; figures cover the entity across all its filing names.