Data / Medical devices / United States / Haleon US HOLDINGS LLC
Haleon US HOLDINGS LLC: FDA-registered device maker in Warren, NJ, United States, 3 510(k) clearances
Haleon US HOLDINGS LLC is registered with the FDA (registration 3012293198) in Warren, NJ, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 4, 2013. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012293198
- Address
- 184 Liberty Corner RD, Warren, NJ, United States, 07059
- Owner or operator
- Haleon (2510369)
- Roles
- Specification developer
- First device listed
- April 30, 2002
- Registered through
- 2026
- Brand names listed
- Biotene Dry Mouth Gentle Oral Rinse Gentle Mint, Biotene Dry Mouth Oral Rinse Fresh Mint, Biotene Gentle Oral Rinse, Biotene Moisturizing Spray, Biotene Mouth Spray, Biotene Oral Balance Gel, Biotene Original Oral Rinse, DENTURE CLEANSERS (VARIOUS) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cleanser, Denture, Over The Counter | EFT | 1 | Specification developer | accessdata.fda.gov |
| Saliva, Artificial | LFD | U | Specification developer | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 4, 2013 | K123731 | BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY | LFD | Substantially Equivalent | Glaxosmithkline Consumer Healthcare (Gskch) | accessdata.fda.gov |
| July 20, 2011 | K103745 | BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF | LFD | Substantially Equivalent | Glaxosmithkline Consumer Healthcare (Gskch) | accessdata.fda.gov |
| July 25, 2006 | K061331 | ORAL BALANCE LIQUID/ GEL | LFD | Substantially Equivalent | Laclede, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 25, 2016 | 74030 | Class III | Terminated | Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ) | Some cartons used in the secondary packaging of Breathe Right Clear, Large, 30 ct. Nasal Strips were incorrectly labeled for cartons intended for the AU/NZ market. | accessdata.fda.gov |
Compare with other makers
- All makers of Toothbrush, Manual
- All makers of Saliva, Artificial
- All makers of Cleanser, Denture, Over The Counter
Updated July 11, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.