4% MENTHOL COLD 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: 4% MENTHOL COLD THERAPY
Generic name: MENTHOL
Manufacturer: Universal Distribution Center LLC
Product type: HUMAN OTC DRUG
SPL set ID: 66892993-a755-4584-b2a8-2e8d7ac70593
SPL ID: b0944dc2-c53e-45e3-92f0-2b45bcb277a3
Version: 1
Effective date: 2026-01-08
Source export date: 2026-10-27
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/eeb012fd0992efa4f76b2aef09dd5f84150b96392c46717c44deabcc4e3581c1/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:37:56

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		4% MENTHOL COLD THERAPY	openfda.brand_name
generic name		MENTHOL	openfda.generic_name
manufacturer name		Universal Distribution Center LLC	openfda.manufacturer_name
ndc	package	52000-442-15	openfda.package_ndc
ndc	product	52000-442	openfda.product_ndc
ndc11	package	52000044215	derived:openfda.package_ndc
rxcui		415974	openfda.rxcui
spl id		b0944dc2-c53e-45e3-92f0-2b45bcb277a3	id
spl set id		66892993-a755-4584-b2a8-2e8d7ac70593	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 When using this product • avoid contact with eyes • do not apply to wounds or damaged skin • do not bandage tightly • do not use with heating pads or heating devices Stop use and consult a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days Flammable: Keep away from excessive heat or open flame If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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