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 94 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Stop Itch GelDIPHENHYDRAMINE HCLWalgreens Co23586336-8f46-3dcd-e063-6394a90accc92025-05-04WarningsExact identifier
application number: M017
WaxRx EarAcheRx Pain Relieving Drops4% LIDOCAINE HCLDOCTOR EASY MEDICAL PRODUCTS, LLC34156655-8706-f0a4-e063-6294a90acc902025-05-01WarningsExact identifier
application number: M017
foster and thrive anti itch creamDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEStrategic Sourcing Services LLCbb08293d-5db8-4cc8-9fe3-bd02061dbeb92025-04-30WarningsExact identifier
application number: M017
Maximum Strength 4% Lidocaine PatchLIDOCAINESolis Pharmaceuticals Inc.3061d301-2104-b1b2-e063-6394a90a9b6e2025-04-29WarningsExact identifier
application number: M017
Maximum Strength 4% Lidocaine PatchLIDOCAINEInterMed Laboratories Private Limited33ed754e-8852-d5b2-e063-6394a90a7cf22025-04-29WarningsExact identifier
application number: M017
Cold Hot Medicated Patch 5% MentholMENTHOLInterMed Laboratories Private Limited33ee6e48-243e-4ded-e063-6394a90a987d2025-04-29WarningsExact identifier
application number: M017
Lidocaine Pain Relief Gel-PatchLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd32b96689-8e9b-4c2e-e063-6294a90a7d1c2025-04-29WarningsExact identifier
application number: M017
Lidocaine Pain Relief Gel-PatchLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd3304e362-dcda-3f5e-e063-6294a90a70152025-04-29WarningsExact identifier
application number: M017
Lidocaine Pain Relief Gel-PatchLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd2f2f753d-c791-e863-e063-6394a90aec5d2025-04-29WarningsExact identifier
application number: M017
Lidocaine Pain Relief Gel-PatchLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd3162c96a-061d-2971-e063-6394a90a9b742025-04-29WarningsExact identifier
application number: M017
Ivarest Poison Ivy Removal and Itch ReliefPRAMOXINE HYDROCHLORIDEBlistex Inc.dedbf5d9-0f86-4f32-8321-da86c9838c0a2025-04-29WarningsExact identifier
application number: M017
HealthWise 2X Medicated Pain Relief Cream Roll-onMENTHOLVeridian Healthcare33dae8a8-4197-f276-e063-6294a90aea832025-04-28WarningsExact identifier
application number: M017
HealthWise Roll-on Menthol Pain Relief GelMENTHOLVeridian Healthcare33dbb939-9397-7e70-e063-6294a90ac8f42025-04-28WarningsExact identifier
application number: M017
Stopain Extra Strength GelMENTHOLTroy Manufacturing, Inc.fa1a98bc-c233-410d-a20e-71111c8973722025-04-28WarningsExact identifier
application number: M017
Lidocaine Patch 4%LIDOCAINE 4%Medcore LLCb961906c-fe66-466b-af2c-072781fa098b2025-04-28WarningsExact identifier
application number: M017
Walgreens Lidocaine Knee and ElbowLIDOCAINEWalgreen Co.a3fb4c78-1493-4ba4-ae83-502dd825ed672025-04-25WarningsExact identifier
application number: M017
Walgreens Lidocaine BackLIDOCAINEWalgreen Co.e6bfd342-c0db-46b9-b5e6-5acbd860adf12025-04-25WarningsExact identifier
application number: M017
Electrum Numb FoamLIDOCAINE HCIRENU LABORATORIES, LLCc8472932-28b7-9189-e053-2a95a90a44df2025-04-25WarningsExact identifier
application number: M017
Benadryl Extra Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC66a2fd60-1757-45cc-a195-ecb9241dca2a2025-04-24WarningsExact identifier
application number: M017
Jakwork Numbing CreamNUMBING CREAMGuangzhou Zanming Trading Co., Ltd.3385cddb-609f-62e8-e063-6294a90add812025-04-24WarningsExact 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