🇺🇸 Permethrin Cream in United States

FDA authorised Permethrin Cream on 31 March 1986 · 16 US adverse-event reports

Marketing authorisations

FDA — authorised 31 March 1986

  • Application: NDA019435
  • Marketing authorisation holder: GLAXOSMITHKLINE
  • Local brand name: NIX
  • Indication: LOTION — TOPICAL
  • Status: approved

Read official source →

FDA — authorised 2 May 1990

  • Application: NDA019918
  • Marketing authorisation holder: MEDTECH PRODUCTS
  • Local brand name: NIX
  • Indication: LOTION — TOPICAL
  • Status: approved

Read official source →

FDA — authorised 28 March 2000

  • Application: ANDA075014
  • Marketing authorisation holder: ACTAVIS MID ATLANTIC
  • Local brand name: PERMETHRIN
  • Indication: LOTION — TOPICAL
  • Status: approved

Read official source →

FDA — authorised 20 December 2001

  • Application: ANDA076090
  • Marketing authorisation holder: PERRIGO NEW YORK
  • Local brand name: PERMETHRIN
  • Indication: LOTION — TOPICAL
  • Status: approved

Read official source →

FDA — authorised 21 April 2003

  • Application: ANDA076369
  • Marketing authorisation holder: PADAGIS ISRAEL
  • Local brand name: PERMETHRIN
  • Indication: CREAM — TOPICAL
  • Status: approved

Read official source →

FDA — authorised 1 August 2023

  • Application: ANDA209732
  • Marketing authorisation holder: DR REDDYS LABS EU
  • Local brand name: PERMETHRIN
  • Indication: CREAM — TOPICAL
  • Status: approved

Read official source →

FDA

  • Status: approved

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Drug Ineffective — 3 reports (18.75%)
  2. Drug Dose Omission — 2 reports (12.5%)
  3. Headache — 2 reports (12.5%)
  4. Nausea — 2 reports (12.5%)
  5. Oral Infection — 2 reports (12.5%)
  6. Actinomycosis — 1 report (6.25%)
  7. Aeromona Infection — 1 report (6.25%)
  8. Allergy To Arthropod Bite — 1 report (6.25%)
  9. Allergy To Chemicals — 1 report (6.25%)
  10. Arthralgia — 1 report (6.25%)

Source database →

Permethrin Cream in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Permethrin Cream approved in United States?

Yes. FDA authorised it on 31 March 1986; FDA authorised it on 2 May 1990; FDA authorised it on 28 March 2000.

Who is the marketing authorisation holder for Permethrin Cream in United States?

GLAXOSMITHKLINE holds the US marketing authorisation.