GingiCaine Gel, Cotton Candy Flavor

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, Cotton Candy Flavor
Generic name: GINGICAINE GEL, COTTON CANDY FLAVOR
Manufacturer: Gingi-Pak a Division of the Belport
Product type: HUMAN OTC DRUG
SPL set ID: 628515a5-175f-ac2c-e053-2991aa0a19ce
SPL ID: 55203a5d-d7c7-a5e1-e063-6294a90a20e2
Version: 4
Effective date: 2026-06-25
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 05:26:24

Harmonized routes table
Harmonized routes
DENTAL, ORAL, PERIODONTAL

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 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M022	openfda.application_number
brand name		GingiCaine Gel, Cotton Candy Flavor	openfda.brand_name
generic name		GINGICAINE GEL, COTTON CANDY FLAVOR	openfda.generic_name
manufacturer name		Gingi-Pak a Division of the Belport	openfda.manufacturer_name
ndc	package	10129-037-01	openfda.package_ndc
ndc	package	10129-037-05	openfda.package_ndc
ndc	product	10129-037	openfda.product_ndc
ndc11	package	10129003701	derived:openfda.package_ndc
ndc11	package	10129003705	derived:openfda.package_ndc
rxcui		238910	openfda.rxcui
spl id		55203a5d-d7c7-a5e1-e063-6294a90a20e2	id
spl set id		628515a5-175f-ac2c-e053-2991aa0a19ce	set_id
unii		U3RSY48JW5	openfda.unii

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 For topical use only. Methemoglobinemia warning Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in the blood. Symptoms may occur within minutes to 1–2 hours after use and include: • Pale, gray, or blue‑colored skin, lips, and nail beds • Shortness of breath • Fatigue or lack of energy Stop use and ask a doctor if: • Sore throat is severe and more than 2 days • Fever, headache, rash, nausea, or vomiting occur • Mouth does not heal within 7 days • Irritation, pain, or redness worsens

Reported adverse events (FAERS/openFDA)#

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