FDA.reportPublic FDA data

FDA label e900d223-464b-4381-a738-ea63159fc55e

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
3bc41400-dd9b-4fca-adf3-be245fd269eb
SPL ID
e900d223-464b-4381-a738-ea63159fc55e
Version
2
Effective date
2011-04-01
Source export date
2026-09-28
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:17:11

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Allergy alert : do not use this product if your baby has a history of allergy to clove, its components eugenol, or to Balsam of Peru Do not use more than directed for more than 7 days unless told to do so by a dentist or doctor When using this product fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If symptoms do not go away, advise your dentist or doctor. Stop use and ask a dentist or doctor if sore mouth symptoms do not get better in 7 days irritation, pain or redness does not go away swelling, rash or fever develops

Reported adverse events (FAERS/openFDA)#

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