SOMBRA COOL 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 COOL THERAPY
Generic name: MENTHOL
Manufacturer: SOMBRA COSMETICS INC.
Product type: HUMAN OTC DRUG
SPL set ID: 87e9b16b-1cab-48f7-b9e4-1c3eaeeb3ca3
SPL ID: 4ffb85fd-c60e-3f70-e063-6294a90a6fdc
Version: 12
Effective date: 2026-04-21
Source export date: 2026-09-28
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:27:16

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 COOL THERAPY	openfda.brand_name
generic name		MENTHOL	openfda.generic_name
manufacturer name		SOMBRA COSMETICS INC.	openfda.manufacturer_name
ndc	package	61577-3103-1	openfda.package_ndc
ndc	product	61577-3103	openfda.product_ndc
ndc11	package	61577310301	derived:openfda.package_ndc
rxcui		415976	openfda.rxcui
spl id		4ffb85fd-c60e-3f70-e063-6294a90a6fdc	id
spl set id		87e9b16b-1cab-48f7-b9e4-1c3eaeeb3ca3	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 . 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.