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OTC · Paste · Oral

Stannous Fluoride

Brands: Sensodyne Rapid Relief · Sensodyne Repair And Protect · Sensodyne Repair And Protect Extra Fresh · Sensodyne Repair And Protect Whitening +4 · Stannous Fluoride

1 ACTIVE SUPPLIER — US
openFDA · updated weekly
US10 NDCs
1 active makers
UKComing
soon
CAComing
soon
AUComing
soon
EUComing
soon
ATCA01AA04
RxCUI (US)10030
US makers1 labelers
Packages18
DEA / ScheduleNone

Medicaid dispensing volume

No Medicaid utilization on record for this drug concept yet. Quarterly volume (CMS State Drug Utilization Data) loads with the utilization ETL.

Who makes it1 active · 0 exited

US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.

LabelerTypePackagesStatus
Haleon US Holdings LLCunknown18SUPPLYING

Regulatory & supply eventsFDA · US

Shortages, recalls, and registration changes attached to this drug concept.

  • Mar 6, 2017
    RECALLRecall (Class II): Sensodyne Repair & Protect Whitening, (stannous fluoride 0.45% (0.15% w/v fluoride ion)), Net Wt. 3.4 oz, Distributed b…

    Presence of Foreign Substance; low concentration of an additional flavoring ingredient, Patchouli oil resulting in complaints of off flavor/scent — Recalling firm: GSK Consumer Healthcare — Nationwide

  • Jul 15, 2015
    RECALLRecall (Class II): SENSODYNE EXTRA FRESH REPAIR & PROTECT, 3.4 oz. (96.4 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Dist…

    Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. — Recalling firm: GlaxoSmithkline Consmer Healthcare — Nationwide, Puerto Rico & Taiwan

  • Jul 15, 2015
    RECALLRecall (Class II): SENSODYNE WITH FLUORIDE REPAIR & PROTECT, a) 0.8 oz.(23 g) tubes, (NDC 0135-0548-01); b) 3.4 oz. (96.4 g) tubes, (NDC …

    Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. — Recalling firm: GlaxoSmithkline Consmer Healthcare — Nationwide, Puerto Rico & Taiwan