FDA label b8bc7031-d85b-5ae3-e053-2a95a90aa3ed

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: 94f7037d-2733-7eda-e053-2a95a90ad6b6
SPL ID: b8bc7031-d85b-5ae3-e053-2a95a90aa3ed
Version: 2
Effective date: 2021-01-12
Source export date: 2026-09-28
Source partition: 5
Source file: https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:30:17

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		b8bc7031-d85b-5ae3-e053-2a95a90aa3ed	id
spl set id		94f7037d-2733-7eda-e053-2a95a90ad6b6	set_id

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 As with any drug, ask a doctor before use if pregnant or breast-feeding. Do not use more than directed. DO NOT SWALLOW. Consult a dentist or physician if: symptoms persist for more than 7 days or worsen. swelling, rash or fever develops. irritation, pain or redness persists or worsens. Keep this and all medications out of the reach of children. In case of emergency or if you accidentally swallow more than used for rinsing, contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Reported adverse events (FAERS/openFDA)#

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