X-Treme Freeze

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: X-Treme Freeze
Generic name: COLD THERAPY GEL
Manufacturer: Dynarex Corporation
Product type: HUMAN OTC DRUG
SPL set ID: 79f0802f-03ad-bf8f-e053-2991aa0ae4b5
SPL ID: 48fdd7f5-f062-0f63-e063-6294a90a452a
Version: 6
Effective date: 2026-01-22
Source export date: 2026-10-12
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/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:38:44

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 · 25 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M017	openfda.application_number
brand name		X-Treme Freeze	openfda.brand_name
generic name		COLD THERAPY GEL	openfda.generic_name
manufacturer name		Dynarex Corporation	openfda.manufacturer_name
ndc	package	67777-144-11	openfda.package_ndc
ndc	package	67777-144-40	openfda.package_ndc
ndc	package	67777-144-41	openfda.package_ndc
ndc	package	67777-144-20	openfda.package_ndc
ndc	package	67777-144-10	openfda.package_ndc
ndc	package	67777-144-21	openfda.package_ndc
ndc	package	67777-144-71	openfda.package_ndc
ndc	package	67777-144-70	openfda.package_ndc
ndc	product	67777-144	openfda.product_ndc
ndc11	package	67777014411	derived:openfda.package_ndc
ndc11	package	67777014440	derived:openfda.package_ndc
ndc11	package	67777014421	derived:openfda.package_ndc
ndc11	package	67777014470	derived:openfda.package_ndc
ndc11	package	67777014410	derived:openfda.package_ndc
ndc11	package	67777014420	derived:openfda.package_ndc
ndc11	package	67777014441	derived:openfda.package_ndc
ndc11	package	67777014471	derived:openfda.package_ndc
rxcui		415974	openfda.rxcui
spl id		48fdd7f5-f062-0f63-e063-6294a90a452a	id
spl set id		79f0802f-03ad-bf8f-e053-2991aa0ae4b5	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 Stop use and ask a doctor if: • Condition worsens • Symptoms last more than 7 days or clear up and occur again within a few days, discontinue use of this product If pregnant or breast feeding: Ask a health professional before use. Keep out of reach of children If swallowed, get medical help. Contact a physician or Poison Control Center (1-800-222-1222) right way.

Reported adverse events (FAERS/openFDA)#

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