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 20 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stud 100 Male Genital DesensitizerLIDOCAINEPound International Corpd075656e-b13f-4a1d-bbb6-501e642698d52026-05-12WarningsExact identifier
application number: M017
CeraVe Developed with Dermatologists Itch Relief MoisturizingPRAMOXINE HYDROCHLORIDEL'Oreal USA Products Inc13ce57d0-b1c5-4685-ad7d-a562d9d8fc862026-05-12WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYCVS Pharmacydb6f518d-3a0e-43f8-8d19-7382d9b7ff1c2026-05-11WarningsExact identifier
application number: M017
Cool and HeatMENTHOLAMERISOURCE BERGENf2bb0e8e-c4cd-0e8c-e053-2995a90a6df72026-05-11WarningsExact identifier
application number: M017
Instaflex Extra Strength Pain Relief CreamMENTHOL, METHYL SALICYLATEHealthy Directions, LLCd058c64d-0e4f-45aa-8f52-804961b562e32026-05-11WarningsExact identifier
application number: M017
BonicaEaseX Hot Capsicum Pain RelievingCAPSICUMPlanet (Anhui) Pharmaceutical Co.,Ltdca6e48af-af6d-4808-a576-0319d2080d382026-05-11WarningsExact identifier
application number: M017
BonicaEaseX Pain Relieving LidocaineLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.7486fe89-a377-4a37-997d-e3bd16b891a72026-05-11WarningsExact identifier
application number: M017
YYSDMVY NUMBING CreamLIDOCAINE 4% NUMBING CREAMJiangxi Yudexi Pharmaceutical Co., LTD5195f5ec-8524-77f5-e063-6294a90abdc22026-05-11WarningsExact identifier
application number: M017
Lightning X Burn Relief GelLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.515eb4cc-63af-c11d-e063-6294a90a13ca2026-05-09WarningsExact identifier
application number: M017
Albertson Lidocaine, Menthol Pain Relief Medicated PatchLIDOCAINE AND MENTHOLSafewaydc647647-90ec-6beb-e053-2a95a90a79822026-05-09WarningsExact identifier
application number: M017
5 Elementum Lidocaine Male Genital DesensitizerLIDOCAINE MALE GENITAL DESENSITIZERMSVENTURESGROUP O514b1738-886e-a95d-e063-6294a90aa7072026-05-08WarningsExact identifier
application number: M017
Kroger Muscle Rub CreamMENTHOL, CAMPHOR, METHYL SALICYLATEKroger Co.45c8c79a-b4b4-d4be-e063-6394a90a92512026-05-08WarningsExact identifier
application number: M017
Walmart Equate Aloe Sunburn Relief CoolingLIDOCAINEWAL-MART STORES INC.51540f6b-596f-bc47-e063-6294a90a46ae2026-05-08WarningsExact identifier
application number: M017
Capsaicin 0.035% creamCAPSAICINMedcore LLC0236e1e4-c26c-4fff-a83b-143ce26d93bf2026-05-07WarningsExact identifier
application number: M017
Lidocaine 4% CreamLIDOCAINEMedcore LLC111cb421-ba3b-4772-ab60-d31eb41831682026-05-07WarningsExact identifier
application number: M017
Lidocaine 5% CreamLIDOCAINEMedcore LLC15d02b42-bf8b-486a-a081-f6d17cc11ec72026-05-07WarningsExact identifier
application number: M017
JenGufun LIDOCAINE Pain Relief Gel-PatchLIDOCAINE PAIN RELIEF GEL-PATCHHenan Kangdi Medical Devices Co., Ltd.51363a41-5dcc-6a3b-e063-6294a90a6c272026-05-07WarningsExact identifier
application number: M017
LidoxiLIDOCAINET&T Pharma Holdings LLC513c517e-c098-02aa-e063-6294a90ac8a42026-05-07WarningsExact identifier
application number: M017
Harris Teeter HydrocortisoneHYDROCORTISONEHARRIS TEETER LLC4e8199f8-96ec-5342-e063-6294a90afb2d2026-05-07WarningsExact identifier
application number: M017
CAREALL Hydrocortisone Maximum StrengthHYDROCORTISONENew World Imports, Inc.5114cdba-96a1-c399-e063-6294a90aac122026-05-06WarningsExact 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