Gel Cooling Pain Relief

Product NDC: 11344-894
11-digit product format: 113440894
Labeler code: 11344
Product ID: 11344-894_5b86bd3c-493e-70b8-e063-6294a90a1225
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol
Dosage form: GEL
Route: TOPICAL
Labeler: Nice-Pak Products, LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-01-13
Substance: MENTHOL
Active strength: 40 mg/mL
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: Gel Cooling Pain Relief
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	40 mg/mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11344-894-18	Gel Cooling Pain Relief	74 mL in 1 BOTTLE, WITH APPLICATOR	GEL	74		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11344-894	GEL COOLING PAIN RELIEF (MENTHOL) GEL [CONSUMER PRODUCT PARTNERS, LLC]	3	Current NDC, 1 package rows	20250406_696f678d-8f76-4087-a52e-efe3c9f814d0.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 152 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Red hot	CAPSAICIN	The Hygenic Company, LLC	d100092c-e10b-2063-e053-2995a90aedb2	2023-10-25	Warnings	Exact identifier application number: M017
Stopain Clinical	MENTHOL	Troy Manufacturing, Inc.	c8d4ae28-efc4-6a00-e053-2a95a90a40bf	2023-10-25	Warnings	Exact identifier application number: M017
Cryo10 Topical Analgesic	MENTHOL	Element 26 LLC	ff1d2140-9302-918c-e053-6394a90acb9a	2023-10-25	Warnings	Exact identifier application number: M017
Stopain Clinical	MENTHOL	Troy Manufacturing, Inc.	3336cc35-e773-4705-84b5-61040604beef	2023-10-25	Warnings	Exact identifier application number: M017
CARMEX Multi-Symptom 3 in 1 COLD Sore treatment External Analgesic Skin Protectant	BENZOCAINE, WHITE PETROLATUM	Carma Laboratories, Inc.	bbf0abcd-b7d6-b5e4-e053-2995a90a5240	2023-10-25	Warnings	Exact identifier application number: M017
Carmex Classic Lip Balm Medicated	CAMPHOR (SYNTHETIC), WHITE PETROLATUM	Carma Laboratories, Inc.	bbee66b9-39ff-4e7e-e053-2995a90a43be	2023-10-25	Warnings	Exact identifier application number: M017
XtraCare Ice Cold Topical Analgesic Gel	MENTHOL	Rejoice International	d38f3099-d940-44d8-aa7f-404157c5e0e3	2023-10-24	Warnings	Exact identifier application number: M017
Family Wellness	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Zhejiang Jingwei Pharmaceutical Co., Ltd.	fefbe351-1cd9-4a2f-a43d-51e2c4eb180b	2023-10-24	Warnings	Exact identifier application number: M017
TheraPlus Plus	MENTHOL	Zhejiang Jingwei Pharmaceutical Co., Ltd.	d4119f84-eb60-4134-b58e-de13d9601199	2023-10-24	Warnings	Exact identifier application number: M017
Family Wellness	HYDROCORTISONE	Zhejiang Jingwei Pharmaceutical Co., Ltd.	cddc9c4a-7c58-4225-921a-05d6afb49178	2023-10-24	Warnings	Exact identifier application number: M017
Theraworx Pain Relief Roll- On- Lidocaine	LIDOCAINE HYDROCHLORIDE	AVADIM HOLDINGS, INC.	b4ce3876-f9e3-43ca-810b-75fbe6f887b6	2023-10-23	Warnings	Exact identifier application number: M017
NUMOTIZINE	MENTHOL	Hobart Laboratories, Inc.	9a29ad1b-4ba3-403f-90c9-ee7582fe4535	2023-10-20	Warnings	Exact identifier application number: M017
Numfast Tetracaine Green	TETRACAINE	Unit Dose, Ltd.	77d9e6ea-1cd3-4447-ba74-01cd7143e27c	2023-10-19	Warnings	Exact identifier application number: M017
Liprotek	PETROLATUM, LIDOCAINE	Unit Dose, Ltd.	051cfa27-bd7c-4f8c-b3e6-03ee0b7a3aa5	2023-10-19	Warnings	Exact identifier application number: M017
GENUINE FIRST AID Antiseptic Pain Relieving	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	bc7c6739-6068-4694-adc9-0c0c5c347df4	2023-10-19	Warnings	Exact identifier application number: M017
CVS Itch relief moisturizing	PRAMOXINE HCL 1%	CVS Health	f3a753fc-f448-6bba-e053-2a95a90a8e1b	2023-10-18	Warnings	Exact identifier application number: M017
Zylotrol	LIDOCAINE HCL 4%, MENTHOL 1%	Asclemed USA, Inc.	e13984ea-73a9-2894-e053-2995a90a8ed6	2023-10-16	Warnings	Exact identifier application number: M017
EXOTEN-C	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Asclemed USA, Inc.	76ed37e0-64b5-4abe-a03c-3dc7084a3919	2023-10-16	Warnings	Exact identifier application number: M017
Calypxo Pain Relief	METHYL SALICYLATE, MENTHOL	Asclemed USA, Inc	bd9d0bc0-5705-4c73-bcd6-f6cdb68e05b6	2023-10-16	Warnings	Exact identifier application number: M017
Calypxo HP Pain Relief	METHYL SALICYLATE, MENTHOL	Asclemed USA, Inc	89a8c267-bd92-4d0d-8e50-c52224aff9cd	2023-10-16	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	696f678d-8f76-4087-a52e-efe3c9f814d0	4
415974	menthol 0.04 MG/MG Topical Gel	SCD	696f678d-8f76-4087-a52e-efe3c9f814d0	4
415974	menthol 4 % Topical Gel	SY	696f678d-8f76-4087-a52e-efe3c9f814d0	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
11344-894-18	11344089418	74 mL in 1 BOTTLE, WITH APPLICATOR (11344-894-18)	74 ml	2021-01-13	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Swan 894.002/894AC Cooling Pain Relief Gel	Nice-Pak Products, LLC	2026-09-15	HUMAN OTC DRUG LABEL	5