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 141 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LEADER Camphor Spirit	CAMPHOR (NATURAL)	Cardinal Health, 110 dba Leader	7d3b0b28-5190-0622-e053-2991aa0af561	2023-12-22	Warnings	Exact identifier application number: M017
Antiseptic Instant Pain Relief	CAMPHOR 10.8% AND PHENOL 4.7%	Pharma Nobis, LLC	e42f484d-a642-3489-e053-2a95a90a4254	2023-12-22	Warnings	Exact identifier application number: M017
Itch Relief Gel	ITCH RELIEF GEL	Pharma Nobis, LLC	e42f484d-a641-3489-e053-2a95a90a4254	2023-12-22	Warnings	Exact identifier application number: M017
Witch Hazel	WITCH HAZEL	Pharma Nobis, LLC	e42f484d-a644-3489-e053-2a95a90a4254	2023-12-22	Warnings	Exact identifier application number: M017
Dermoplast Pain relieving	BENZOCAINE, MENTHOL	Advantice Health	dad00c95-4e11-3eec-e053-2a95a90a7a18	2023-12-21	Warnings	Exact identifier application number: M017
equate Maximum Strength Pain Relieving 4% Lidocaine with Lavender Essential Oil Topical analgesic	LIDOCAINE HYDROCHLORIDE	Wal-Mart Stores, Inc.	bf954949-a7b7-44ba-8565-f1d5c0a6c0d1	2023-12-21	Warnings	Exact identifier application number: M017
Bactine Max Bandage	LIDOCAINE	WellSpring Pharmaceutical Corporation	465dc46e-6435-4569-9516-f648d0fe0f09	2023-12-21	Warnings	Exact identifier application number: M017
Valtrum IMMEDIATE ACTION TOPICAL ANALGESIC	CAMPHOR, MENTHOL, METHYL SALICYLATE	LABORATORIOS QUANTIUM LLC	c4efa317-8dd1-49e1-b7ca-9df2147edd3e	2023-12-21	Warnings	Exact identifier application number: M017
DDM Camphor Spirit	CAMPHOR 10%	Discount Drug Mart	5d56cbe6-4e48-79eb-e053-2a91aa0a74d3	2023-12-20	Warnings	Exact identifier application number: M017
Quality Choice Camphor Spirit	CAMPHOR 10%	Chain Drug Market Association	8d352a67-2024-43d0-b525-038d398949e6	2023-12-20	Warnings	Exact identifier application number: M017
Instant Antiseptic Pain Relief	CAMPHOR 10.8% AND PHENOL 4.7%	Chain Drug Market Association	2cd60df3-bfde-4747-ba4f-7121612f2e63	2023-12-20	Warnings	Exact identifier application number: M017
Poison Ivy Wash	PRAMOXINE HCL	Chain Drug Market Association	873a546b-90ae-50cb-e053-2a91aa0adbfb	2023-12-20	Warnings	Exact identifier application number: M017
Premier Value Instant Antiseptic Pain Relief	CAMPHOR 10.8% AND PHENOL 4.7%	Pharmacy Value Alliance LLC	9d63f8ed-fc50-0d84-e053-2a95a90a6e92	2023-12-20	Warnings	Exact identifier application number: M017
Ear Drops	CARBAMIDE PEROXIDE 6.5%	CVS Pharmacy	8a872991-01af-5fd0-e053-2995a90ac7f4	2023-12-20	Warnings	Exact identifier application number: M017
CVS Cold and Hot Roll-On	COOL AND HEAT PAIN RELIEF	CVS Pharmacy	b8cc578a-be6d-90c0-e053-2995a90a7742	2023-12-20	Warnings	Exact identifier application number: M017
Sunmark Camphor Spirit	CAMPHOR 10%	Strategic Sourcing Services LLC	667b3a9f-4a5c-4ef0-adbd-cce9a5f94faa	2023-12-19	Warnings	Exact identifier application number: M017
DDM Instant Antiseptic Pain Relief	CAMPHOR 10.8% AND PHENOL 4.7%	Discount Drug Mart	5d56c74f-604d-4fed-e053-2a91aa0a417c	2023-12-19	Warnings	Exact identifier application number: M017
HEB Camphor Phenol	CAMPHOR 10.8% AND PHENOL 4.7%	H E B	5d573883-001d-e5a4-e053-2991aa0a6203	2023-12-18	Warnings	Exact identifier application number: M017
Petrocort Antipruritic Lip 21	HYDROCORTISONE	Clinical Formula LLC	7d408e08-d777-4dfb-bb5e-b4fe5d6f4c7b	2023-12-15	Warnings	Exact identifier application number: M017
DermaWound Wound Care Venous Stasis	BENZOCAINE HYDROCHLORIDE	Progressive Doctors, LLC	6221ba86-8b7f-48c8-8284-6950f9fc36b1	2023-12-15	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