COLD AND HOT MEDICATED

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: COLD AND HOT MEDICATED
Generic name: MENTHOL
Manufacturer: Universal Distribution Center LLC
Product type: HUMAN OTC DRUG
SPL set ID: c19aa620-401d-43c4-804c-3611cc39e9f2
SPL ID: 9e02f5b6-ecf5-4f1e-8b28-196b86d0f325
Version: 7
Effective date: 2025-09-29
Source export date: 2026-10-12
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/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:31:45

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 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M017	openfda.application_number
brand name		COLD AND HOT MEDICATED	openfda.brand_name
generic name		MENTHOL	openfda.generic_name
manufacturer name		Universal Distribution Center LLC	openfda.manufacturer_name
ndc	package	52000-422-41	openfda.package_ndc
ndc	package	52000-422-42	openfda.package_ndc
ndc	product	52000-422	openfda.product_ndc
ndc11	package	52000042241	derived:openfda.package_ndc
ndc11	package	52000042242	derived:openfda.package_ndc
rxcui		420222	openfda.rxcui
spl id		9e02f5b6-ecf5-4f1e-8b28-196b86d0f325	id
spl set id		c19aa620-401d-43c4-804c-3611cc39e9f2	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 • use only as directed • do not bandage tightly or use with a heating pad • avoid contact with eyes and mucous membranes • do not apply to wounds or damaged skin. Stop use and ask a doctor if • condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days • redness is present • skin irritation develops. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Reported adverse events (FAERS/openFDA)#

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