RE-LEVE

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: RE-LEVE
Generic name: MENTHOL
Manufacturer: SOMBRA COSMETICS INC.
Product type: HUMAN OTC DRUG
SPL set ID: b4b39d79-0439-41e7-adca-e5ccb8f44e40
SPL ID: 364d60f1-80e4-1ee1-e063-6394a90ab590
Version: 6
Effective date: 2025-05-29
Source export date: 2026-10-30
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-30/8d15bdc5962e7531569eaeb5b1b2e4919574d40a6782ab67345a27b890175a00/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 19:57:29

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 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M017	openfda.application_number
brand name		RE-LEVE	openfda.brand_name
generic name		MENTHOL	openfda.generic_name
manufacturer name		SOMBRA COSMETICS INC.	openfda.manufacturer_name
ndc	package	61577-3242-4	openfda.package_ndc
ndc	package	61577-3242-5	openfda.package_ndc
ndc	product	61577-3242	openfda.product_ndc
ndc11	package	61577324204	derived:openfda.package_ndc
ndc11	package	61577324205	derived:openfda.package_ndc
spl id		364d60f1-80e4-1ee1-e063-6394a90ab590	id
spl set id		b4b39d79-0439-41e7-adca-e5ccb8f44e40	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 Keep out of reach of children. For external use only . Avoid contact with eyes and mucous membranes, wounds or damaged skin. Do not use with heating pads. Stop uses and ask a doctor if : Conditions worsen, symptoms persist for more than 7 days, symptoms clear up and occur again within a few days.

Reported adverse events (FAERS/openFDA)#

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