FDA.reportPublic FDA data

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 57 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LenzaPro FlexLIDOCAINE/MENTHOLSOLA Pharmaceuticalsba498f1d-460b-f4e6-e053-2995a90a57552025-12-08WarningsExact identifier
application number: M017
LidaFlexLIDOCAINESOLA Pharmaceuticalsb9e49529-13b4-1b0b-e053-2995a90adc7a2025-12-08WarningsExact identifier
application number: M017
Rugby Menthol Hot Cold PatchMENTHOLRUGBY LABORATORIESc68d29c2-9b56-4994-e053-2a95a90ae60e2025-12-08WarningsExact identifier
application number: M017
Neuracin Topical GelNEURACIN TOPICAL ANALGESIC GELSOLA Pharmaceuticalsc3166926-30c2-2128-e053-2a95a90a0bf22025-12-08WarningsExact identifier
application number: M017
TriceptinLIDOCAINE / MENTHOL / METHYL SALICYLATESOLA Pharmaceuticalsef1b98ab-d2db-038c-e053-2995a90a94b42025-12-08WarningsExact identifier
application number: M017
SynoFlex PatchSYNOFLEX PATCHSola Pharmaceuticalsde2042c4-6c5e-7365-e053-2a95a90ada2a2025-12-08WarningsExact identifier
application number: M017
AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 1NICOTINE TRANSDERMAL PATCHESPCHEERY LLC457c860b-091d-8350-e063-6294a90a2f982025-12-08WarningsExact identifier
application number: M017
AY BENDITO HEMPMENTHOL, CAMPHORAY BENDITO INTERNATIONAL, INC457c9bd6-2e72-03e5-e063-6394a90a558c2025-12-08WarningsExact identifier
application number: M017
AY BENDITO HEMP ROLL-ONCAMPHOR, MENTHOLAY BENDITO INTERNATIONAL, INC3e552afc-9305-8825-e063-6294a90a1afe2025-12-08WarningsExact identifier
application number: M017
AY BENDITO HEMPCAMPHOR, MENTHOLAY BENDITO INTERNATIONAL, INC457d89aa-4a84-94a6-e063-6294a90a20c02025-12-08WarningsExact identifier
application number: M017
Gold Bond Medicated Anti-ItchPRAMOXINE HYDROCHLORIDE, MENTHOLGold Bond Co LLC4a2bd277-47dd-4ae6-9b4b-e0ae9aad226b2025-12-05WarningsExact identifier
application number: M017
Orajel for Cold Sores Double Medicated, CreamBENZOCAINE AND WHITE PETROLATUMChurch & Dwight Co., Inc.b8699a40-8464-ca02-e053-2995a90a42602025-12-05WarningsExact identifier
application number: M017
Thompson Hydrocortisone 1%HYDROCORTISONEThompsonf8740314-7e1f-815e-e053-6294a90a6eae2025-12-05WarningsExact identifier
application number: M017
JUST CBD SOOTHING UNSCENTEDLIDOCAINE HCLJust Brands LLC453f44e2-9e5b-8695-e063-6394a90a43892025-12-05WarningsExact identifier
application number: M017
JUST CBD ROLL-ON COOLINGMENTHOLJust Brands LLC453fa1a7-368c-ae50-e063-6294a90a55072025-12-05WarningsExact identifier
application number: M017
JUST CBD ROLL-ON WARMINGCAMPHORJust Brands LLC4540221f-cf9f-9b6a-e063-6294a90adec32025-12-05WarningsExact identifier
application number: M017
Gold Bond Extra StrengthMENTHOLGold Bond Co LLC3e84375f-95d3-420c-b222-02a7574125922025-12-04WarningsExact identifier
application number: M017
Alocane PlusLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products LLCb3ec09b9-7511-0895-e053-2a95a90a78402025-12-04WarningsExact identifier
application number: M017
Gold Bond Medicated Pain and Itch ReliefLIDOCAINE HYDROCHLORIDEGold Bond Co LLCd240e9b8-3506-42ab-8a50-05e8d3fac4ff2025-12-04WarningsExact identifier
application number: M017
BLT Skin CreamBENZOCAINE, LIDOCAINE, TETRACAINEM2B Pharma LLC9dc5db9d-9e0a-cd28-e053-2995a90a6bf72025-12-04WarningsExact 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