Home NDC 70000-0618 Leader Cooling Pain Relief
Product NDC 70000-0618
11-digit product format 700000618
Labeler code 70000
Product ID 70000-0618_da117303-a16f-45d4-9e19-5edf8f706d02
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 Cooling Pain Relief
Brand name suffix Topical Analgesic
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL, UNSPECIFIED FORM 40 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 415974 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70000-0618-1 Leader Cooling Pain ReliefTopical Analgesic 89 mL in 1 TUBE GEL 89 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70000-0618 LEADER COOLING PAIN RELIEF TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM) GEL [CARDINAL HEALTH, 110 DBA LEADER] 2 Current NDC, Legacy NDC, 1 package rows 20240315_fd06d17f-4dff-42a9-a84f-904809ceb981.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 18 of 153 · 3,057 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70000-0618-1 70000061801 89 mL in 1 TUBE (70000-0618-1) 89 ml 2022-11-03 0000-00-00 No No Current