SOMBRA WARM THERAPY

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: SOMBRA WARM THERAPY
Generic name: MENTHOL CAMPHOR
Manufacturer: SOMBRA COSMETICS INC.
Product type: HUMAN OTC DRUG
SPL set ID: de78dba9-53b3-4dbd-9dd2-6a692378da34
SPL ID: 503818c4-aafa-b69c-e063-6294a90a034e
Version: 16
Effective date: 2026-04-24
Source export date: 2026-10-27
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/d7629e6f844435cfe6cb0cf8c5341c46775ea16c5af42c77a22a2ffe820a2cd2/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 19:51:01

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		SOMBRA WARM THERAPY	openfda.brand_name
generic name		MENTHOL CAMPHOR	openfda.generic_name
manufacturer name		SOMBRA COSMETICS INC.	openfda.manufacturer_name
ndc	package	61577-3100-1	openfda.package_ndc
ndc	product	61577-3100	openfda.product_ndc
ndc11	package	61577310001	derived:openfda.package_ndc
spl id		503818c4-aafa-b69c-e063-6294a90a034e	id
spl set id		de78dba9-53b3-4dbd-9dd2-6a692378da34	set_id
unii		L7T10EIP3A	openfda.unii
unii		5TJD82A1ET	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 . Do not use on wounds or damaged skin. When using this product : avoid bandaging tightly, avoid contact with eyes, keep out of reach of children . Stop use and ask doctor if : condition worsens, symptoms persist for more than 7 days, 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.