Cool and Heat

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 and Heat
Generic name: MENTHOL
Manufacturer: AMERISOURCE BERGEN
Product type: HUMAN OTC DRUG
SPL set ID: f2bb0e8e-c4cd-0e8c-e053-2995a90a6df7
SPL ID: 518f947e-eb42-5fad-e063-6294a90a9656
Version: 4
Effective date: 2026-05-11
Source export date: 2026-11-06
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/2026-11-06/2233cb6af8c6b55a5e4a05449e8db0d2f259f3c061d5d001b654a8bea1cc1db2/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 07:53:35

Harmonized routes table
Harmonized routes
TOPICAL

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 · 10 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M017	openfda.application_number
brand name		Cool and Heat	openfda.brand_name
generic name		MENTHOL	openfda.generic_name
manufacturer name		AMERISOURCE BERGEN	openfda.manufacturer_name
ndc	package	46122-743-27	openfda.package_ndc
ndc	product	46122-743	openfda.product_ndc
ndc11	package	46122074327	derived:openfda.package_ndc
spl id		518f947e-eb42-5fad-e063-6294a90a9656	id
spl set id		f2bb0e8e-c4cd-0e8c-e053-2995a90a6df7	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 For external use only. When using this product ▪ use only as directed ▪ do not bandage tightly or use with a heating pad ▪ avoid contact with eyes and mucous membranes ▪ do not apply to wounds or damaged, broken or irritated skin ▪ A temporary burning sensation may occur after use but normally disappears in several days. ▪ If a severe burning sensation occurs, discontinue use immediately ▪ If swelling or blistering of the skin occurs, stop use and seek and seek medical attention ▪ Do not expose treated area to hear or direct sunlight.

Reported adverse events (FAERS/openFDA)#

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