Hielo Ardiente

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: Hielo Ardiente
Generic name: MENTHOL
Manufacturer: Menper Distributors, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 97ec516c-d2bc-47ce-82fe-bd68445d9570
SPL ID: 3a876b4d-bba4-c8d4-e063-6394a90abaa0
Version: 4
Effective date: 2025-07-22
Source export date: 2026-09-28
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:14:40

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M017	openfda.application_number
brand name		Hielo Ardiente	openfda.brand_name
generic name		MENTHOL	openfda.generic_name
manufacturer name		Menper Distributors, Inc.	openfda.manufacturer_name
ndc	package	53145-002-01	openfda.package_ndc
ndc	product	53145-002	openfda.product_ndc
ndc11	package	53145000201	derived:openfda.package_ndc
rxcui		1039043	openfda.rxcui
spl id		3a876b4d-bba4-c8d4-e063-6394a90abaa0	id
spl set id		97ec516c-d2bc-47ce-82fe-bd68445d9570	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 Avoid contact with eyes Do not use if condition worsens If symptoms persist for more than 5 days or recur, discontinue use and consult a physician Do not apply to open wounds or damaged skin Do not bandage tightly Do not use with heating pads or heating devices Use only as directed

Reported adverse events (FAERS/openFDA)#

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