FDA applicant

Smithkline Beecham Consumer Healthcare Products

Parsippany, NJ1 decision1994–19940 recalls

FDA records 1 decision for Smithkline Beecham Consumer Healthcare Products (Parsippany, NJ) in 1994: 1 510(k) clearance. All are in product code EJR (Agent, Polishing, Abrasive, Oral Cavity). No recall is linked to its devices.

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

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Smithkline Beecham Consumer Healthcare Products’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Smithkline Beecham Consumer Healthcare Products since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Smithkline Beecham Consumer Healthcare Products by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Smithkline Beecham 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

Other applicant names beginning “Smithkline”

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

Smithkline Diagnostics, Inc. 42 Smithkline Beecham Corp. 1

Smithkline Beecham Consumer Healthcare Products

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Smithkline”