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 6 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Non-proprietary name	HEADACHE PATCH	Nanjing 3H Medical Products Co.,Ltd.	586d73f1-0b0b-f596-e063-6394a90a4d57	2026-08-06	Warnings	Exact identifier application number: M017
Point Relief Coldspot Pain Relieving	MENTHOL	Fabrication Enterprises Inc	479fb728-4aeb-42e3-b238-f04255514baa	2026-08-05	Warnings	Exact identifier application number: M017
Dealmed Burn	LIDOCAINE	Dealmed Medical Supplies, LLC.	3b5f7ded-c275-4d7f-9fd4-539797d5507e	2026-08-05	Warnings	Exact identifier application number: M017
Lidocaine HCl	LIDOCAINE HCL	Topco Associates LLC	584e1f35-4d99-9c85-e063-6294a90ab3d0	2026-08-05	Warnings, Adverse reactions	Exact identifier application number: M017
Hempe HOT Muscle and Joint Gel	HEMPE	Healthcare International Research Limited	5854a80e-c92b-3ff5-e063-6294a90a2d05	2026-08-05	Warnings	Exact identifier application number: M017
Lidocaine Plantar Relief Roll-On	LIDOCAINE	Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.	585ccb4b-3bff-39b9-e063-6294a90a0e18	2026-08-05	Warnings	Exact identifier application number: M017
Green MARVEL PAIN RELIEF	MENTHOL, CAMPHOR, METHYL SALICYLATE	Miramar Cosmetics, Inc DBA Miramar Lab	9ff6e477-ef79-4a0c-9e21-8cae0e5d8810	2026-08-05	Warnings	Exact identifier application number: M017
tuiwaro LIDOCAINE Cream	LIDOCAINE CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	56e36592-a935-61d4-e063-6294a90a6e4c	2026-08-04	Warnings	Exact identifier application number: M017
Mineral Ice Extreme Menthol Pain Relief	MENTHOL	Carlin Consumer Health LLC	584f5c6e-3385-3221-e063-6294a90aabae	2026-08-04	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	484fe5e4-a058-49c0-a382-c8fc3e20c3b2	2026-08-04	Warnings	Exact identifier application number: M017
procure	HYDROCORTISONE ACETATE	TWIN MED, LLC	2670c9c4-66ad-40e8-a08a-582b160de39d	2026-08-03	Warnings	Exact identifier application number: M017
Wini By Locsanity Advanced Formula Muscle Joint Relief Balm	METHYL SALICYLATE,CAMPHOR,MENTHOL	Locsanity LLC	5829b5d7-78d4-78a2-e063-6394a90a3dfc	2026-08-03	Warnings	Exact identifier application number: M017
Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll On	MENTHOL	Chattem, Inc.	aa40c907-eeb5-4fda-b35e-439cbecc178c	2026-07-31	Warnings	Exact identifier application number: M017
Alphamale Delay Cream	BENZOCAINE	Prodigy Media Inc	53d682ee-0802-a16d-e063-6394a90aeee1	2026-07-31	Warnings	Exact identifier application number: M017
Pure Primal Delay Cream	BENZOCAINE	Prodigy Media Inc	57e9e894-c14f-d806-e063-6394a90ab8e5	2026-07-31	Warnings	Exact identifier application number: M017
Satohap	DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE	Sato Pharmaceutical Co., Ltd.	df0e2b83-8f61-4ed8-bcc4-55e4ea782090	2026-07-31	Warnings	Exact identifier application number: M017
Satogesic	DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE	Sato Pharmaceutical Co., Ltd.	cb000134-92a4-4304-8ef0-0347190e1414	2026-07-31	Warnings	Exact identifier application number: M017
Satogesic Hot	CAPSAICIN	Sato Pharmaceutical Co., Ltd.	16b47cb5-ea5f-4514-9a89-141ee4cc60f8	2026-07-31	Warnings	Exact identifier application number: M017
Satohap Cool and Hot Pads	CAMPHOR, CAPSAICIN, MENTHOL	Sato Pharmaceutical Co., Ltd.	b6bf1eab-4ab9-f500-e053-2995a90a8d7b	2026-07-31	Warnings, Adverse reactions	Exact identifier application number: M017
SATOHAP COOL and HOT	CAMPHOR, CAPSAICIN, MENTHOL	Sato Pharmaceuticals Co., Ltd.	232a4c76-1a0c-2f4b-e063-6394a90a8849	2026-07-31	Warnings, Adverse reactions	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