U.S. FDA indication matrix

U.S. botulinum toxin indications are product-specific label claims. A shared indication does not make two products interchangeable, unit-equivalent, identically dosed, equally approved for every patient group, or clinically superior to one another.

This matrix summarizes the current U.S. labeled indications for the botulinum toxin products represented in the brand graph: Botox / Botox Cosmetic, Myobloc, Dysport, Xeomin, Jeuveau, Daxxify, and Letybo. It is a regulatory orientation table, not a dosing guide, treatment recommendation, or therapeutic-equivalence comparison.

Label scope is product-specific

FDA labels define approved uses for a specific product, route, dose language, and patient population. Botulinum toxin potency units cannot be compared or converted across products; start with unit interpretation and product-specific prescribing information before reading any cross-brand claim.

Current U.S. Indication Matrix

Product	Label scope	Current U.S. labeled indications	Adult / pediatric limits	FDA label source
Botox / Botox Cosmetic	OnabotulinumtoxinA therapeutic Botox label plus Botox Cosmetic aesthetic label; AbbVie / Allergan company context.	Therapeutic Botox: overactive bladder; detrusor overactivity associated with a neurologic condition; prophylaxis of headaches in adults with chronic migraine; spasticity; cervical dystonia; severe primary axillary hyperhidrosis; blepharospasm; strabismus. Botox Cosmetic: moderate to severe glabellar lines, lateral canthal lines / crow’s feet, forehead lines, and platysma bands.	Therapeutic label includes adult uses and selected pediatric uses by indication; Botox Cosmetic indications are for adults.	Botox therapeutic label; Botox Cosmetic label
Myobloc	RimabotulinumtoxinB type B therapeutic label; Supernus current company context.	Cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia; chronic sialorrhea.	Adult indications.	Myobloc label
Dysport	AbobotulinumtoxinA therapeutic and aesthetic label; Ipsen and Galderma relationship context.	Cervical dystonia; glabellar lines; upper and lower limb spasticity in adults; upper and lower limb spasticity in pediatric patients where specified by label.	Adult cervical dystonia, adult glabellar lines, adult spasticity, and pediatric spasticity from 2 years of age where the label specifies.	Dysport label
Xeomin	IncobotulinumtoxinA therapeutic and aesthetic label; Merz Pharma company context.	Chronic sialorrhea; upper limb spasticity; cervical dystonia; blepharospasm; glabellar lines.	Includes adult indications and pediatric chronic sialorrhea / upper limb spasticity limits specified by label.	Xeomin label
Jeuveau	PrabotulinumtoxinA-xvfs aesthetic label; Evolus commercialization and Daewoong manufacturing context.	Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity.	Adult patients.	Jeuveau label
Daxxify	DaxibotulinumtoxinA-lanm aesthetic and therapeutic label; Revance / Crown company context.	Temporary improvement in the appearance of moderate to severe glabellar lines; treatment of cervical dystonia.	Adult patients.	Daxxify label
Letybo	LetibotulinumtoxinA-wlbg aesthetic label; Hugel company context.	Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity.	Adult patients.	Letybo label

Product-Specific Reading Notes

Botox requires extra care because Botox and Botox Cosmetic have separate U.S. label contexts. The same nonproprietary name, onabotulinumtoxinA, does not collapse therapeutic and aesthetic indications into one universal claim. Botox Cosmetic also has aesthetic indications, such as forehead lines and platysma bands, that are not yet represented as separate indication pages in this index.

Myobloc is the represented type B product. Its cervical dystonia indication makes it visible beside type A therapeutic products, but serotype, potency units, dose language, and adverse-effect interpretation remain product-specific.

Dysport and Xeomin both have therapeutic and aesthetic U.S. label contexts. Shared use areas such as cervical dystonia, spasticity, blepharospasm, or glabellar lines should be read through each product’s own label rather than as evidence of substitutability.

Jeuveau and Letybo are narrow U.S. aesthetic-label entries in the current graph. Their Korean manufacturing connections help explain market structure, but U.S. indication interpretation remains tied to the Jeuveau and Letybo labels rather than to regional portfolio names.

Daxxify combines an adult glabellar-line aesthetic indication with an adult cervical dystonia therapeutic indication. That broader U.S. label scope does not establish unit equivalence, duration superiority, or clinical preference over other products.

How to Use the Matrix

Use this table to answer whether a represented product has a current U.S. labeled indication. Use the U.S. FDA approval timeline to understand when major U.S. approval anchors entered the record. Use indication pages for clinical context and safety framing for cautious interpretation, not as substitutes for current prescribing information.

Sources

This matrix uses FDA prescribing-information PDFs and Drugs@FDA label records as the primary source trail for U.S. labeled indications. FDA and DailyMed label materials were last checked on June 9, 2026. Labels can change, so current prescribing information remains the authority for approved uses, dosing language, warnings, preparation, and patient populations.