COOL RELIEF ORAL ANESTHETIC

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: COOL RELIEF ORAL ANESTHETIC
Generic name: MENTHOL
Manufacturer: Ricola USA Inc.
Product type: HUMAN OTC DRUG
SPL set ID: d66f47a9-35ab-4bf9-8065-c81abcb503f5
SPL ID: c1038250-ebbe-4fd8-a0f0-030a9209d7ff
Version: 3
Effective date: 2024-12-10
Source export date: 2026-09-28
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:04:16

Harmonized routes table
Harmonized routes
ORAL

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M022	openfda.application_number
brand name		COOL RELIEF ORAL ANESTHETIC	openfda.brand_name
generic name		MENTHOL	openfda.generic_name
manufacturer name		Ricola USA Inc.	openfda.manufacturer_name
ndc	package	63667-513-10	openfda.package_ndc
ndc	product	63667-513	openfda.product_ndc
ndc11	package	63667051310	derived:openfda.package_ndc
rxcui		2277805	openfda.rxcui
spl id		c1038250-ebbe-4fd8-a0f0-030a9209d7ff	id
spl set id		d66f47a9-35ab-4bf9-8065-c81abcb503f5	set_id
unii		L7T10EIP3A	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 Do not use in children under 5 years of age unless directed by a doctor Sore throat warnings: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. These may be serious.

Reported adverse events (FAERS/openFDA)#

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