510(k) Report

FDA applicant

Glaxosmithkline Consumer Healthcare (Gskch)

Parsippany, NJ3 decisions2010–20131 recall

FDA records 3 decisions for Glaxosmithkline Consumer Healthcare (Gskch) (Parsippany, NJ) from 2010 to 2013: 3 510(k) clearances. All are in product code LFD (Saliva, Artificial). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

How often FDA has decided Glaxosmithkline Consumer Healthcare (Gskch)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2010: 12011: 12013: 1
2010high 1 (2010) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2013

2013: 1
2010high 1 (2013) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Glaxosmithkline Consumer Healthcare (Gskch) by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Glaxosmithkline Consumer Healthcare…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LFDSaliva, Artificial3decisions

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 13 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K123731Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene Moisturizing Mouth SprayGlaxosmithkline Consumer Healthcare (Gskch) · 20139cite it
  • K101477Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth MouthwashGlaxosmithkline Consumer Healthcare (Gskch) · 20103cite it
  • K103745Biotene Moisturizing Mouth Spray for Dry Mouth Symptom ReliefGlaxosmithkline Consumer Healthcare (Gskch) · 20111cites it

What has FDA decided for it lately?

  • K123731Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene Moisturizing Mouth SprayGlaxosmithkline Consumer Healthcare (Gskch) · 20131 recall
  • K103745Biotene Moisturizing Mouth Spray for Dry Mouth Symptom ReliefGlaxosmithkline Consumer Healthcare (Gskch) · 2011
  • K101477Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth MouthwashGlaxosmithkline Consumer Healthcare (Gskch) · 2010

All 3 as Glaxosmithkline Consumer Healthcare (Gskch) →

What has been recalled?

1 recall linked to its devices; the latest:

  • K123731Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5…Oct 17, 2013Class II

Other applicant names beginning “Glaxosmithkline”

FDA records each applicant name separately; these may or may not be the same firm.

Glaxosmithkline Consumer Healthcare 4