FDA.reportPublic FDA data

FDA label 3d1086cb-02c9-4011-952e-7b7ce4b2d9fb

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
3808cb8a-c3e2-4406-957d-c57705d0a650
SPL ID
3d1086cb-02c9-4011-952e-7b7ce4b2d9fb
Version
4
Effective date
2022-09-07
Source export date
2026-10-12
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:59:08

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Anaphylaxis, as well as serious allergic reactions, have been reported during postmarketing use with dental products containing chlorhexidine.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 2 matching rows.

adverse reactions

ADVERSE REACTIONS The most frequently observed adverse events in the two pivotal clinical trials were toothache, upper respiratory tract infection, and headache. Toothache was the only adverse reaction that was significantly higher ( p = 0.042) in the PerioChip group when compared to placebo. Most oral pain or sensitivity occurred within the first week of the initial chip placement following SRP procedures, was mild to moderate in nature, and spontaneously resolved within days. These reactions were observed less frequently with subsequent chip placement at 3 and 6 months. Table 3 lists adverse events, occurring in ≥ 1% of 225 patients that received PerioChip, pooled from the two pivotal clinical trials without regard to causality. Gingival bleeding was the only dental adverse event occurring at a rate of ≤ 1% in both groups. Table 3 Adverse events (frequency ≥ 1% for the PerioChip group) reported from 2 five-center U.S. clinical trials * Includes dental, gingival or mouth pain, tenderness, aching, throbbing, soreness, discomfort, or sensitivity ** Includes broken, cracked or fractured teeth, mobile teeth, and lost bridges, crowns, or fillings PerioChip Total N = 225 Placebo Chip Total N = 222 N % N % All patients with Adverse Events 193 85.8 189 85.1 Toothache* 114 50.7 92 41.4 Upper resp tract infection 64 28.4 58 26.1 Headache 61 27.1 61 27.5 Sinusitis 31 13.8 29 13.1 Influenza-like-symptoms 17 7.6 21 9.5 Back pain 15 6.7 25 11.3 Tooth disorder** 14 6.2 15 6.8 Bronchitis 14 6.2 7 3.2 Abscess 13 5.8 13 5.9 Pain 11 4.9 11 5.0 Allergy 9 4.0 13 5.9 Myalgia 9 4.0 9 4.1 Gum hyperplasia 8 3.6 5 2.3 Pharyngitis 8 3.6 5 2.3 Arthralgia 7 3.1 13 5.9 Dysmenorrhea 7 3.1 13 5.9 Dyspepsia 7 3.1 6 2.7 Rhinitis 6 2.7 11 5.0 Coughing 6 2.7 7 3.2 Arthrosis 6 2.7 4 1.8 Hypertension 5 2.2 6 2.7 Stomatitis ulcerative 5 2.2 1 0.5 Tendinitis 5 2.2 1 0.5

adverse reactions table

<table ID="t3" width="100%"><caption>Table 3 Adverse events (frequency &#x2265; 1% for the PerioChip group) reported from 2 five-center U.S. clinical trials </caption><col width="42.468%" align="left"/><col width="14.383%" align="left"/><col width="14.383%" align="left"/><col width="14.383%" align="left"/><col width="14.383%" align="left"/><tfoot><tr><td colspan="5" align="left" valign="top"><paragraph styleCode="footnote"/></td></tr><tr><td colspan="5" align="left" valign="top"><paragraph styleCode="footnote">* Includes dental, gingival or mouth pain, tenderness, aching, throbbing, soreness, discomfort, or sensitivity </paragraph></td></tr><tr><td colspan="5" align="left" valign="top"><paragraph styleCode="footnote">** Includes broken, cracked or fractured teeth, mobile teeth, and lost bridges, crowns, or fillings </paragraph></td></tr></tfoot><tbody><tr><td align="left" valign="top" styleCode="Toprule Lrule Rrule"/><td colspan="2" align="center" valign="top" styleCode="Toprule Rrule">PerioChip Total N = 225 </td><td colspan="2" align="center" valign="top" styleCode="Toprule Rrule">Placebo Chip Total N = 222 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule"/><td align="center" valign="top">N </td><td align="center" valign="top" styleCode="Rrule">% </td><td align="center" valign="top">N </td><td align="center" valign="top" styleCode="Rrule">% </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule">All patients with Adverse Events </td><td align="center" valign="top">193 </td><td align="center" valign="top" styleCode="Rrule">85.8 </td><td align="center" valign="top">189 </td><td align="center" valign="top" styleCode="Rrule">85.1 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule">Toothache* </td><td align="center" valign="top">114 </td><td align="center" valign="top" styleCode="Rrule">50.7 </td><td align="center" valign="top">92 </td><td align="center" valign="top" styleCode="Rrule">41.4 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule">Upper resp tract infection </td><td align="center" valign="top">64 </td><td align="center" valign="top" styleCode="Rrule">28.4 </td><td align="center" valign="top">58 </td><td align="center" valign="top" styleCode="Rrule">26.1 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule">Headache </td><td align="center" valign="top">61 </td><td align="center" valign="top" styleCode="Rrule">27.1 </td><td align="center" valign="top">61 </td><td align="center" valign="top" styleCode="Rrule">27.5 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule">Sinusitis </td><td align="center" valign="top">31 </td><td align="center" valign="top" styleCode="Rrule">13.8 </td><td align="center" valign="top">29 </td><td align="center" valign="top" styleCode="Rrule">13.1 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule">Influenza-like-symptoms </td><td align="center" valign="top">17 </td><td align="center" valign="top" styleCode="Rrule">7.6 </td><td align="center" valign="top">21 </td><td align="center" valign="top" styleCode="Rrule">9.5 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule">Back pain </td><td align="center" valign="top">15 </td><td align="center" valign="top" styleCode="Rrule">6.7 </td><td align="center" valign="top">25 </td><td align="center" valign="top" styleCode="Rrule">11.3 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule">Tooth disorder** </td><td align="center" valign="top">14 </td><td align="center" valign="top" styleCode="Rrule">6.2 </td><td align="center" valign="top">15 </td><td align="center" valign="top" styleCode="Rrule">6.8 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule">Bronchitis </td><td align="center" valign="top">14 </td><td align="center" valign="top" styleCode="Rrule">6.2 </td><td align="center" valign="top">7 </td><td align="center" valign="top" styleCode="Rrule">3.2 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule">Abscess </td><td align="center" valign="top">13 </td><td align="center" valign="top" styleCode="Rrule">5.8 </td><td align="center" valign="top">13 </td><td align="center" valign="top" styleCode="Rrule">5.9 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule">Pain </td><td align="center" valign="top">11 </td><td align="center" valign="top" styleCode="Rrule">4.9 </td><td align="center" valign="top">11 </td><td align="center" valign="top" styleCode="Rrule">5.0 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule">Allergy </td><td align="center" valign="top">9 </td><td align="center" valign="top" styleCode="Rrule">4.0 </td><td align="center" valign="top">13 </td><td align="center" valign="top" styleCode="Rrule">5.9 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule">Myalgia </td><td align="center" valign="top">9 </td><td align="center" valign="top" styleCode="Rrule">4.0 </td><td align="center" valign="top">9 </td><td align="center" valign="top" styleCode="Rrule">4.1 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule">Gum hyperplasia </td><td align="center" valign="top">8 </td><td align="center" valign="top" styleCode="Rrule">3.6 </td><td align="center" valign="top">5 </td><td align="center" valign="top" styleCode="Rrule">2.3 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule">Pharyngitis </td><td align="center" valign="top">8 </td><td align="center" valign="top" styleCode="Rrule">3.6 </td><td align="center" valign="top">5 </td><td align="center" valign="top" styleCode="Rrule">2.3 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule">Arthralgia </td><td align="center" valign="top">7 </td><td align="center" valign="top" styleCode="Rrule">3.1 </td><td align="center" valign="top">13 </td><td align="center" valign="top" styleCode="Rrule">5.9 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule">Dysmenorrhea </td><td align="center" valign="top">7 </td><td align="center" valign="top" styleCode="Rrule">3.1 </td><td align="center" valign="top">13 </td><td align="center" valign="top" styleCode="Rrule">5.9 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule">Dyspepsia </td><td align="center" valign="top">7 </td><td align="center" valign="top" styleCode="Rrule">3.1 </td><td align="center" valign="top">6 </td><td align="center" valign="top" styleCode="Rrule">2.7 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule">Rhinitis </td><td align="center" valign="top">6 </td><td align="center" valign="top" styleCode="Rrule">2.7 </td><td align="center" valign="top">11 </td><td align="center" valign="top" styleCode="Rrule">5.0 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule">Coughing </td><td align="center" valign="top">6 </td><td align="center" valign="top" styleCode="Rrule">2.7 </td><td align="center" valign="top">7 </td><td align="center" valign="top" styleCode="Rrule">3.2 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule">Arthrosis </td><td align="center" valign="top">6 </td><td align="center" valign="top" styleCode="Rrule">2.7 </td><td align="center" valign="top">4 </td><td align="center" valign="top" styleCode="Rrule">1.8 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule">Hypertension </td><td align="center" valign="top">5 </td><td align="center" valign="top" styleCode="Rrule">2.2 </td><td align="center" valign="top">6 </td><td align="center" valign="top" styleCode="Rrule">2.7 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule">Stomatitis ulcerative </td><td align="center" valign="top">5 </td><td align="center" valign="top" styleCode="Rrule">2.2 </td><td align="center" valign="top">1 </td><td align="center" valign="top" styleCode="Rrule">0.5 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Tendinitis </td><td align="center" valign="top" styleCode="Botrule">5 </td><td align="center" valign="top" styleCode="Botrule Rrule">2.2 </td><td align="center" valign="top" styleCode="Botrule">1 </td><td align="center" valign="top" styleCode="Botrule Rrule">0.5 </td></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.