X-Treme Freeze

Product NDC: 67777-144
11-digit product format: 677770144
Labeler code: 67777
Product ID: 67777-144_48fdd7f5-f062-0f63-e063-6294a90a452a
Type: HUMAN OTC DRUG
Nonproprietary name: Cold Therapy Gel
Dosage form: GEL
Route: TOPICAL
Labeler: Dynarex Corporation
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-08-17
Substance: MENTHOL
Active strength: 4 g/100mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: X-Treme Freeze
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	4 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L7T10EIP3A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
415974	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
79f0802f-03ad-bf8f-e053-2991aa0ae4b5	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67777-144-10	X-Treme Freeze	200 in 1 CASE	GEL	200	6
67777-144-11	X-Treme Freeze	3 mL in 1 PACKET	GEL	3	6
67777-144-11	X-Treme Freeze	100 in 1 BOX	GEL	100	6
67777-144-20	X-Treme Freeze	24 in 1 CASE	GEL	24	6
67777-144-21	X-Treme Freeze	118 mL in 1 TUBE	GEL	118	6
67777-144-40	X-Treme Freeze	12 in 1 CASE	GEL	12	6
67777-144-41	X-Treme Freeze	473 mL in 1 BOTTLE, PUMP	GEL	473	6
67777-144-70	X-Treme Freeze	2 in 1 CASE	GEL	2	6
67777-144-71	X-Treme Freeze	3785 mL in 1 BOTTLE, PLASTIC	GEL	3785	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67777-144-20	ML - Milliliter	67777-144	c5e5bb15-c596-4135-9b13-a9e2bb6d3450	1	2023-02-06
67777-144-21	ML - Milliliter	67777-144	c85e8f2f-7945-46bc-972d-dd9147d19cad	1	2023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67777-144	X-TREME FREEZE (COLD THERAPY GEL) GEL [DYNAREX CORPORATION]	5	Current NDC, Legacy NDC, 9 package rows	20241122_79f0802f-03ad-bf8f-e053-2991aa0ae4b5.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 7 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cortizone 10 Itch Relief Massaging Rollerball	HYDROCORTISONE	Chattem, Inc.	1e27682c-f856-41f1-9935-37540960a4c7	2026-07-31	Warnings	Exact identifier application number: M017
Aspercreme with Lidocaine Dry	LIDOCAINE	Chattem, Inc.	008abaaa-5e12-4246-a7f5-66f3966acf28	2026-07-30	Warnings	Exact identifier application number: M017
ACOLYE Lidocaine Cream Topical Analgesia Cream	LIDOCAINE,MENTHOL	Guangdong Aimu Biological Technology Co., Ltd	57deebf7-52f1-4256-e063-6294a90a75d5	2026-07-30	Warnings	Exact identifier application number: M017
Icy Hot Performance No-Mess Pain Relief Cream	MENTHOL 16%, CAMPHOR 11%	Chattem, Inc.	5e3e272a-c001-4f57-9535-521ccc85ae65	2026-07-30	Warnings	Exact identifier application number: M017
Auixudin Lidocaine Pain Relief Gel-Patch	LIDOCAINE PAIN RELIEF GEL-PATCH	Henan Enokon Medical Instrument Co., Ltd.	57bc7b9e-e2f7-724b-e063-6394a90ab36f	2026-07-29	Warnings	Exact identifier application number: M017
Jinfahe Lidocaine Pain Relief Patch	LIDOCAINE PAIN RELIEF PATCH	Henan Enokon Medical Instrument Co., Ltd.	57bcd9c5-767e-b634-e063-6394a90a2878	2026-07-29	Warnings	Exact identifier application number: M017
Maximun Strength Lidocaine Patch Plus Menthol	LIDOCAINE, MENTHOL	Meijer Distribution Inc	d0468514-58ea-4d8f-b634-a65bf95c0316	2026-07-29	Warnings	Exact identifier application number: M017
Oudetas Lidocaine Cream	LIDOCAINE CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	57ca9220-2778-790a-e063-6294a90af506	2026-07-29	Warnings	Exact identifier application number: M017
Aspercreme Lidocaine No-Mess plus Lavender	LIDOCAINE HCL	Chattem, Inc.	3948a3d2-ce04-4703-8709-211e75c9c38d	2026-07-29	Warnings	Exact identifier application number: M017
Aspercreme Professional Cream	LIDOCAINE HCL 4%	Chattem, Inc.	ef297864-5917-4645-8ec7-f2bc49e037e8	2026-07-29	Warnings	Exact identifier application number: M017
LidoPro	LIDOCAINE AND MENTHOL	Clinic Pharma	cdfd6b39-b430-4e95-a0f7-682cf3d78b52	2026-07-28	Warnings	Exact identifier application number: M017
LidoPro Patch (Lidocaine 4%, Menthol 1%)	LIDOCAINE AND MENTHOL PATCH	Clinic Pharma	2b4d2105-b7ad-2695-e063-6394a90a999b	2026-07-28	Warnings	Exact identifier application number: M017
HEMPE Ice Muscle and Joint Gel	MENTHOL	Healthcare International Research Limited	57aec922-1de4-c579-e063-6394a90af6c8	2026-07-28	Warnings	Exact identifier application number: M017
Earths Care Pain Relieving	CAMPHOR, MENTHOL, METHYL SALICYLATE	DLC Laboratories, Inc.	5c3976da-a6cb-4b94-ae41-3e86b1ab13cb	2026-07-28	Warnings	Exact identifier application number: M017
Muscle Rub Cream	MENTHOL 10%, METHYL SALICYLATE 15%	Preferred Pharmaceuticals Inc.	9e7568b6-52ae-4f7a-9bfd-503fd80a297e	2026-07-28	Warnings	Exact identifier application number: M017
Aspercreme Lidocaine with Rosemary and Mint	LIDOCAINE HYDROCHLORIDE	Chattem, Inc.	9d40bfea-85d0-4943-83e9-0c16e79a011c	2026-07-28	Warnings	Exact identifier application number: M017
KENS PAIN AND ARTHRITIS FORMULA	MENTHOL	Eezaway Relief Inc	35834473-3ad5-41ec-a110-e742aa7e2ee4	2026-07-28	Warnings	Exact identifier application number: M017
DERMFREE Lidocaine 4% NUMBING Topical Anorectal Cream	LIDOCAINE 4% NUMBING TOPICAL ANORECTAL CREAM	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	57935b64-6e2e-85d0-e063-6394a90a7428	2026-07-27	Warnings	Exact identifier application number: M017
1% Hydrocortisone Anti-itch	1% HYDROCORTISONE ANTI-ITCH	ALAINA HEALTHCARE PRIVATE LIMITED	b8416467-55f7-4e5f-a5cb-3abd3e2bb577	2026-07-27	Warnings	Exact identifier application number: M017
OWELL NATURALS ARTHRITIS MAXIMUM STRENGTH	MENTHOL	OWELL NATURAL 8 LLC	57984bc2-bf1d-c423-e063-6394a90a06ae	2026-07-27	Warnings	Exact identifier application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
415974	menthol 4 % Topical Gel	PSN	79f0802f-03ad-bf8f-e053-2991aa0ae4b5	6
415974	menthol 0.04 MG/MG Topical Gel	SCD	79f0802f-03ad-bf8f-e053-2991aa0ae4b5	6
415974	menthol 4 % Topical Gel	SY	79f0802f-03ad-bf8f-e053-2991aa0ae4b5	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67777-144-10	67777014410	200 BOX in 1 CASE (67777-144-10) / 100 PACKET in 1 BOX (67777-144-11) / 3 mL in 1 PACKET	200 box	2018-08-17	0000-00-00	No	No	Current
67777-144-11	67777014411	3 mL in 1 PACKET	3 ml					Historical
67777-144-20	67777014420	24 TUBE in 1 CASE (67777-144-20) / 118 mL in 1 TUBE (67777-144-21)	24 tube	2018-08-17	0000-00-00	No	No	Current
67777-144-21	67777014421	118 mL in 1 TUBE	118 ml					Historical
67777-144-40	67777014440	12 BOTTLE, PUMP in 1 CASE (67777-144-40) / 473 mL in 1 BOTTLE, PUMP (67777-144-41)		2018-08-17	0000-00-00	No	No	Current
67777-144-41	67777014441	473 mL in 1 BOTTLE, PUMP	473 ml					Historical
67777-144-70	67777014470	2 BOTTLE, PLASTIC in 1 CASE (67777-144-70) / 3785 mL in 1 BOTTLE, PLASTIC (67777-144-71)		2018-08-17	0000-00-00	No	No	Current
67777-144-71	67777014471	3785 mL in 1 BOTTLE, PLASTIC	3785 ml					Historical