FDA label 898632e8-9d4e-4a68-a5c7-ec62e33ca6ff

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: 982e6c46-37ab-419b-acea-521b3c356a7c
SPL ID: 898632e8-9d4e-4a68-a5c7-ec62e33ca6ff
Version: 2
Effective date: 2015-05-08
Source export date: 2026-09-28
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:22:22

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		898632e8-9d4e-4a68-a5c7-ec62e33ca6ff	id
spl set id		982e6c46-37ab-419b-acea-521b3c356a7c	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 Do not exceed recommended dosage. Do not use for more than 7 days unless directed by a dentist or doctor if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days infection, pain, or redness persists or worsens swelling, rash or fever develops fever & nasal congestion are present in teething infants 4 months of age and over These symptoms may be a sign of infection or a serious condition.

Reported adverse events (FAERS/openFDA)#

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