Assyro AI

Orange Book product · Brand (NDA)

SALONPAS

MENTHOL; METHYL SALICYLATE

Brand (NDA)NDA 022029OTC HISAMITSU PHARM CO

At a glance

Nov 05, 2012

Approved

Brand (NDA)

Application

Not listed

TE code

2

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 05, 2012

    13 yr 10 mo ago

  2. Today

  3. Patent 9233184 expires

    Listed drug product patent expiration.

    Aug 01, 2027

    in 1 yr 2 mo

  4. Patent 8809615 expires

    Listed drug product patent expiration.

    Jan 03, 2030

    in 3 yr 7 mo

Pharmaceutical detail

Active ingredient

MENTHOL; METHYL SALICYLATE

Strength

3%;10%

Dosage form

PATCH

Route

TOPICAL

TE code

Not listed

Application

NDA 022029

Product number

002

Marketing status

OTC

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9233184Aug 01, 2027in 1 yr 2 mo
Product
8809615Jan 03, 2030in 3 yr 7 mo
Product
Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.