FDA.reportPublic FDA data

Leader Roll-On Cooling Pain Relief

Product NDC
70000-0617
11-digit product format
700000617
Labeler code
70000
Product ID
70000-0617_f835accf-f50d-4831-b28f-881db7ed2e01
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL, UNSPECIFIED FORM
Dosage form
GEL
Route
TOPICAL
Labeler
Cardinal Health, 110 dba LEADER
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-11-03
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
40 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
Leader Roll-On Cooling Pain Relief
Brand name suffix
Topical Analgesic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM40 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
e86cba40-6b10-454d-98b3-6b547456eaadAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0617-1Leader Roll-On Cooling Pain ReliefTopical Analgesic74 mL in 1 BOTTLE, WITH APPLICATORGEL743

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0617-1ML - Milliliter70000-0617f70d2da2-16df-4ecc-a8b1-b3f0ca99efe812023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0617LEADER ROLL-ON COOLING PAIN RELIEF TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM) GEL [CARDINAL HEALTH, 110 DBA LEADER]2Current NDC, Legacy NDC, 1 package rows20240302_e86cba40-6b10-454d-98b3-6b547456eaad.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 92 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SORE NO MORE COOL THERAPYMENTHOLSOMBRA COSMETICS INC.9aa1f0ac-3baf-4e45-9e3a-c28a99b229092025-05-12WarningsExact identifier
application number: M017
Calm and Correct Serum with LidocaineLIDOCAINE 3 PERCENTRenu Laboratories, LLCddcf1c2e-2f67-44d7-e053-2a95a90a812b2025-05-09WarningsExact identifier
application number: M017
Mqupin Knee PatchKNEE PATCHZhengzhou Miaoqi Pharmaceutical Technology Co., Ltd09772e4b-8193-3771-e063-6394a90a95162025-05-08WarningsExact identifier
application number: M017
Hydrocortisone CreamHYDROCORTISONETrifecta Pharmaceuticals USAd57a59fb-c8f2-f73b-e053-2995a90a4cdb2025-05-08WarningsExact identifier
application number: M017
Hydrocortisone CreamHYDROCORTISONETrifecta Pharmaceuticals USA4c96ec41-841c-322b-e054-00144ff8d46c2025-05-08WarningsExact identifier
application number: M017
GNP Extra Strength Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEAmerisource Bergen34a66224-ef3c-e36e-e063-6394a90ac99d2025-05-08WarningsExact identifier
application number: M017
Good Neighbor Muscle Rub CreamCAMPHOR 4.0%, MENTHOL 10.0%, METHYL SALICYLATE 30.0%,Amerisource Bergen34924bb9-e3e8-70e6-e063-6294a90aaa8c2025-05-07WarningsExact identifier
application number: M017
DermaRad Relief Post Radiation CalmingLIDOCAINE 3 PERCENTRenu Laboratories, LLCe5d64929-fb9c-7ebc-e053-2995a90a93182025-05-07WarningsExact identifier
application number: M017
Cold Hot Medicated Patch 5% MentholMENTHOLInterMed Laboratories Private Limited33ee0235-5a6e-0ea1-e063-6394a90a89a52025-05-06WarningsExact identifier
application number: M017
DermaRad ReliefLIDOCAINE EMULSIONRENU LABORATORIES, LLCd5e11f73-918b-eeac-e053-2995a90a4a832025-05-06WarningsExact identifier
application number: M017
Plantar Fasciitis Pain Relief Gel-PatchLIDOCAINE, MENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd34838622-b092-afeb-e063-6294a90ae7db2025-05-06WarningsExact identifier
application number: M017
Climax Shield DelayBENZOCAINEPRODUCT MAX GROUP INC9c720cdc-f753-47ce-95ff-3b26e461a0ab2025-05-05WarningsExact identifier
application number: M017
PediFix Lidocaine Pain-Relief PatchesLIDOCAINE PAIN-RELIEF PATCHESPediFix, Inc346550b9-d2ba-184e-e063-6394a90a591a2025-05-05WarningsExact identifier
application number: M017
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
415974menthol 4 % Topical GelPSNe86cba40-6b10-454d-98b3-6b547456eaad3
415974menthol 0.04 MG/MG Topical GelSCDe86cba40-6b10-454d-98b3-6b547456eaad3
415974menthol 4 % Topical GelSYe86cba40-6b10-454d-98b3-6b547456eaad3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0617-17000006170174 mL in 1 BOTTLE, WITH APPLICATOR (70000-0617-1) 74 ml2022-11-030000-00-00NoNoCurrent