GingiCaine Gel, Chocolate Mint

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)

Brand name
GingiCaine Gel, Chocolate Mint
Generic name
GINGICAINE GEL, CHOCOLATE MINT FLAVOR
Manufacturer
Gingi-Pak a Division of the Belport
Product type
HUMAN OTC DRUG
SPL set ID
6285c4f2-c139-49a9-e053-2991aa0a2b03
SPL ID
556cb4b1-8f13-33c6-e063-6294a90a6892
Version
3
Effective date
2026-06-29
Source export date
2026-10-12
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:44:25
Harmonized routes table
Harmonized routes
DENTAL, ORAL, PERIODONTAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Do not use if you have a history of hypersensitivity to ester–type local anesthetics, not for use with teething or children under 2 years of age. For topical use only Methemoglobinemia warning Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. Consumers are advised to cease use and seek immediate medical attention if they or a child in their care develop: • Pale, gray, or blue colored skin (cyanosis) • Headache • Rapid heart rate • Shortness of breath • Dizziness or lightheadedness • Fatigue or lack of energy Stop use and ask a doctor if (signs of toxicity) • Sore throat is severe and more than 2 days • Fever, headache, rash, nausea, or vomiting develops • Mouth sores do not go away in 7 days • Irritation, pain, or redness worsens

Reported adverse events (FAERS/openFDA)#

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