FDA — authorised 15 August 1996
- Application: NDA050719
- Marketing authorisation holder: CASPER PHARMA LLC
- Local brand name: HELIDAC
- Indication: TABLET, CHEWABLE, TABLET, CAPSULE — ORAL
- Status: approved
🇺🇸 Pepto-Bismol in United States
FDA authorised Pepto-Bismol on 15 August 1996
Marketing authorisations
FDA — authorised 30 November 2018
- Application: ANDA202584
- Marketing authorisation holder: AILEX PHARMS LLC
- Local brand name: BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE
- Indication: TABLET, CHEWABLE, TABLET, CAPSULE — ORAL
- Status: approved
FDA
- Status: approved
Pepto-Bismol in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Pepto-Bismol approved in United States?
Yes. FDA authorised it on 15 August 1996; FDA authorised it on 30 November 2018; FDA has authorised it.
Who is the marketing authorisation holder for Pepto-Bismol in United States?
CASPER PHARMA LLC holds the US marketing authorisation.