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
IngredientStrength
MENTHOL40 mg/mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11344-894-18Gel Cooling Pain Relief74 mL in 1 BOTTLE, WITH APPLICATORGEL744

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11344-894GEL COOLING PAIN RELIEF (MENTHOL) GEL [CONSUMER PRODUCT PARTNERS, LLC]3Current NDC, 1 package rows20250406_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 65 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NeuroMed FABENZOCAINESambria Pharmaceuticals, Inc.97345ed4-51c3-4221-852c-2cd563f333172025-11-12WarningsExact identifier
application number: M017
ZHENG GU SHUICAMPHOR, MENTHOLGUANGXI YULIN PHARMACEUTICAL GROUP CO LTD17552943-4f11-42d6-ad41-fbc53f2bbd9a2025-11-12Warnings, Adverse reactionsExact identifier
application number: M017
NeuroMed FABENZOCAINESambria Pharmaceuticals, Inc.605fc242-ad31-4aa9-bd86-fba4ddf0d3052025-11-12WarningsExact identifier
application number: M017
CAPZIXCAPSAICINToprail Chp Llc.a4555840-cf8f-45d8-90bb-3581102b58a72025-11-12WarningsExact identifier
application number: M017
Hempvana Cold As Ice Pain ReliefMENTHOLTelebrands Corp95e84bb9-ba2e-5009-e053-2995a90a43622025-11-12WarningsExact identifier
application number: M017
LidozallLIDOCAINE HYDROCHLORIDEV2 Pharma LLC1eb2dfb2-3ad1-488b-aed9-17220e34a10c2025-11-12WarningsExact identifier
application number: M017
Lidozall PlusLIDOCAINE HYDROCHLORIDEV2 Pharma LLCba3cbb15-f4ed-443e-af43-a758481acb0b2025-11-12WarningsExact identifier
application number: M017
Knee Pain Relief PatchDL-CAMPHOR, L-MENTHOL, METHYL SALICYLATEShenzhen Finona Information Technology Co., Ltd38755738-1a06-fdb4-e063-6294a90aa6eb2025-11-12WarningsExact identifier
application number: M017
Recovery NumbLIDOCAINE 4%PURKLENZ FORMULATIONS INC.e95e38e3-f743-4f5c-abdf-99ba6856e6f72025-11-12WarningsExact identifier
application number: M017
Rapid ReliefCOLD RELIEF PATCH 5% MENTHOLRAPID AID VIET NAM COMPANY LIMITED434c13c2-52ee-000f-e063-6294a90af7e72025-11-11WarningsExact identifier
application number: M017
Rapid ReliefPAIN RELIEF PATCH CAMPHOR 110MG MENTHOL 33MG CAPSICUM EXTRACT 22MGRAPID AID VIET NAM COMPANY LIMITED434d5f92-05c2-d884-e063-6394a90ad28c2025-11-11WarningsExact identifier
application number: M017
Rapid ReliefPAIN RELIEF PATCH LIDOCAINE 4% MENTHOL 1%RAPID AID VIET NAM COMPANY LIMITED434df0be-49ff-aa56-e063-6394a90a3b5a2025-11-11WarningsExact identifier
application number: M017
TopCare Pain Relief Maximum StrengthLIDOCAINE HYDROCHLORIDETOPCO ASSOCIATESb0ae3a7c-52d1-4923-bd50-6bb3749006c82025-11-11WarningsExact identifier
application number: M017
ComfortcaineLIDOCAINE HCLQS Key West Aloe, LLC831b7c11-e437-4e74-808e-c9c1eb8b82f62025-11-11WarningsExact identifier
application number: M017
A and E Marathon Delay SerumDELAY SERUMPhe Inc4355d1d8-44fe-aca1-e063-6294a90a85ff2025-11-11WarningsExact identifier
application number: M017
A and E Deep Throat Desensitizing SprayStrawberryORAL NUMBING SPRAY STRAWBERRYPhe Inc4355dab1-a293-ded6-e063-6394a90af9b02025-11-11WarningsExact identifier
application number: M017
A and E Easy Anal GelANAL NUMBING LUBRICANTPhe Inc4355e0f3-65ba-eca6-e063-6394a90ab43c2025-11-11WarningsExact identifier
application number: M017
A and E Deep Throat Desensitizing SprayPeppermintORAL NUMBING SPRAY MINTPhe Inc4355e0d0-1222-d594-e063-6294a90abb292025-11-11WarningsExact identifier
application number: M017
DermaNumb AnalgesicLIDOCAINE HCLA.T.S. Laboratories, LLC0ea46890-45c3-4732-bc47-227f7c67daf12025-11-11WarningsExact identifier
application number: M017
Derma Numb Pain ReliefLIDOCAINE HCLA.T.S. Laboratories, LLC710991ae-8f82-4893-93a7-0ef3f815d1322025-11-11WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
415974menthol 4 % Topical GelPSN696f678d-8f76-4087-a52e-efe3c9f814d04
415974menthol 0.04 MG/MG Topical GelSCD696f678d-8f76-4087-a52e-efe3c9f814d04
415974menthol 4 % Topical GelSY696f678d-8f76-4087-a52e-efe3c9f814d04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11344-894-181134408941874 mL in 1 BOTTLE, WITH APPLICATOR (11344-894-18) 74 ml2021-01-13NoNoCurrent