Hot/Cold Menthol 16% Roll-On

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: Hot/Cold Menthol 16% Roll-On
Generic name: HOT/COLD MENTHOL 16% ROLL-ON
Manufacturer: Pharma Nobis, LLC
Product type: HUMAN OTC DRUG
SPL set ID: 4f6f5a0b-3bfa-289e-e063-6294a90a94b3
SPL ID: 4f6f50c3-79af-1aac-e063-6294a90a1a63
Version: 1
Effective date: 2026-04-14
Source export date: 2026-10-12
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:55:49

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		Hot/Cold Menthol 16% Roll-On	openfda.brand_name
generic name		HOT/COLD MENTHOL 16% ROLL-ON	openfda.generic_name
manufacturer name		Pharma Nobis, LLC	openfda.manufacturer_name
ndc	package	82645-014-97	openfda.package_ndc
ndc	product	82645-014	openfda.product_ndc
ndc11	package	82645001497	derived:openfda.package_ndc
spl id		4f6f50c3-79af-1aac-e063-6294a90a1a63	id
spl set id		4f6f5a0b-3bfa-289e-e063-6294a90a94b3	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

For external use only. Flammable Keep away from fire or flame. 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 severe burning sensation occurs, discontinue use immediately if swelling or blistering of the skin occurs, stop use and seek medical attention do not expose treated area to heat or direct sunlight

Reported adverse events (FAERS/openFDA)#

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