Haleon US Holdings LLC

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
13148191314819Haleon US Holdings LLC1N2026-01-013169 Route 145 East Durham NY US 12423
30122931983012293198Haleon US HOLDINGS LLC1N2026-01-01184 LIBERTY CORNER RD Warren NJ US 07059

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2067111417949907K123731BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAYLFD2013-01-04
2067111656416605K103745BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEFLFD2011-07-20
2067111842604639K061331ORAL BALANCE LIQUID/ GELLFD2006-07-25
2067111483763338DEN220078EroxonQWW2023-06-09
20671116355591161969-12-31
20671116355591161969-12-31
20671116355591161969-12-31
20671116355591161969-12-31
1238921143669791
2067111143669791
2067111449469601

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
LFD32013-01-04
QWW12023-06-09

PMA

PMN

Applications

GUDID

Eroxon

2025-04-01

Haleon US Holdings LLC

Eroxon

2024-09-26

Haleon US Holdings LLC