Gel Cooling Pain Relief

Product NDC
76162-894
11-digit product format
761620894
Labeler code
76162
Product ID
76162-894_4ab9eb4d-361b-c4bc-e063-6394a90a316d
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
GEL
Route
TOPICAL
Labeler
Topco Associates LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-06-24
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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
80962394-a46f-48fd-8e0c-685dd1e500d7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-894-21Gel Cooling Pain Relief89 mL in 1 TUBEGEL8926

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-894GEL COOLING PAIN RELIEF (MENTHOL) GEL [TOPCO]24Current NDC, Legacy NDC, 1 package rows20240814_80962394-a46f-48fd-8e0c-685dd1e500d7.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 95 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PICKLEBALM LIDOCAINE WITH MENTHOL ARNICA CUCUMBER SEEDLIDOCAINE, MENTHOLCompass Health Brands Corp.2bd8aae0-2606-c7f2-e063-6294a90a9a202025-04-22WarningsExact identifier
application number: M017
Mqforu Pain PatchPAIN PATCHZhengzhou Miaoqi Medical Technology Co., Ltd.1f878abd-54cd-1963-e063-6294a90a18842025-04-22WarningsExact identifier
application number: M017
PICKLEBALM LIDOCAINE WITH MENTHOL ARNICA CUCUMBER SEED ROLL ONLIDOCAINE, MENTHOLCompass Health Brands Corp.2c25fa5e-9546-ba74-e063-6294a90aadf42025-04-22WarningsExact identifier
application number: M017
PICKLEBALM LIDOCAINE WITH MENTHOL ARNICA CUCUMBER SEED BALMLIDOCAINE, MENTHOLCompass Health Brands Corp.2bd8cfb6-ab6c-9e04-e063-6294a90a2d522025-04-22WarningsExact identifier
application number: M017
Maximum Strength 4% Lidocaine PatchLIDOCAINEPharmheal32e57c0f-d138-88dc-e063-6394a90ac0852025-04-16WarningsExact identifier
application number: M017
COLD HOT CHINESE RED TIGER PAIN RELIEF GeI-PatchMENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd32b7d73c-a191-7843-e063-6394a90aa6312025-04-14WarningsExact identifier
application number: M017
Methyl Salicylate 25% CreamMETHYL SALICYLATEMARCELLA HEALTH32c153c7-de30-504e-e063-6294a90a40202025-04-14WarningsExact identifier
application number: M017
Dollar General Cold-Hot Medicated PatchesMENTHOLDOLGENCORP, LLCe13ab4d3-eb58-4874-925a-6a59df4dd29a2025-04-14WarningsExact identifier
application number: M017
AY BENDITO - PAIN RELIEFCAMPHOR, MENTHOLAY BENDITO INTERNATIONAL, INCb97f6b71-7de7-3217-e053-2a95a90aa4262025-04-14WarningsExact identifier
application number: M017
AY BENDITO - THERMOACTIVECAMPHOR, MENTHOLAY BENDITO INTERNATIONAL, INCbbf0d85e-269d-0342-e053-2995a90ac63c2025-04-14WarningsExact identifier
application number: M017
Biofreeze MentholMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC71a36691-9d9e-479d-bfdc-6f6b192ad2d02025-04-11WarningsExact identifier
application number: M017
Eagle MedicatedMENTHOL METHYL SALICYLATEBorden Company (Private) Limitedda3358ae-8679-6045-e053-2a95a90a50e32025-04-10WarningsExact identifier
application number: M017
JointflexJOINTFLEXStrides Consumer LLCb82ec69c-bd00-400b-bd94-ac15fb620f9b2025-04-09WarningsExact identifier
application number: M017
Zepol Topical AnalgesicCAMPHOR, MENTHOLLaboratorios Zepol S.A.ca20ade6-9b35-40bb-b3b2-fc3a0e1eece92025-04-09WarningsExact identifier
application number: M017
JointflexCAMPHORStrides Consumer LLCcb5ca02b-0bc1-4b0b-b4b1-abef3222aa562025-04-09WarningsExact identifier
application number: M017
Foster and Thrive Lidocaine Pain Relief PatchLIDOCAINE 4%Strategic Sourcing Services LLC32456887-aa09-8912-e063-6394a90a4ae72025-04-08WarningsExact identifier
application number: M017
MUSCLEMENTHOLWATER-JEL TECHNOLOGIES1af399af-07b0-4899-9bcc-1e244b63b1cf2025-04-08WarningsExact identifier
application number: M017
Lidocaine with MentholLIDOCAINE HCL AND MENTHOLKareway Product, Inc.9ee46a5b-d00c-4254-e053-2995a90aeb3a2025-04-08WarningsExact identifier
application number: M017
Foster and Thrive Lidocaine Pain Relief PatchLIDOCAINE 4%Strategic Sourcing Services LLC324802c9-e2c2-bf74-e063-6394a90a86972025-04-08WarningsExact identifier
application number: M017
OARS AND ALPS MUSCLE RECOVERY BALMMENTHOL, METHYL SALICYLATECosco International, Inc8745802f-018d-4cf8-bbf3-3b04c8f545382025-04-08WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
415974menthol 4 % Topical GelPSN80962394-a46f-48fd-8e0c-685dd1e500d726
415974menthol 0.04 MG/MG Topical GelSCD80962394-a46f-48fd-8e0c-685dd1e500d726
415974menthol 4 % Topical GelSY80962394-a46f-48fd-8e0c-685dd1e500d726

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76162-894-217616208942189 mL in 1 TUBE (76162-894-21) 89 ml2021-06-240000-00-00NoNoCurrent