Home NDC 70000-0546 Leader Anti-Itch
Product NDC 70000-0546
11-digit product format 700000546
Labeler code 70000
Product ID 70000-0546_43fa4c6d-3b73-48ab-e063-6394a90ae0f4
Type HUMAN OTC DRUG
Nonproprietary name Camphor, Menthol
Dosage form LOTION
Route TOPICAL
Labeler LEADER/Cardinal Helath 110, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-01-21
Substance CAMPHOR (SYNTHETIC); MENTHOL
Active strength .5; .5 g/100g; g/100g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70000-0546-7 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 70000-0546-7 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 70000-0546-7 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 70000-0546-7 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 70000-0546-7 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 70000-0546-7 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 70000-0546-7 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 70000-0546-7 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 70000-0546-7 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 70000-0546-7 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 70000-0546-7 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 70000-0546-7 557ba5c1ecfa…9c80585c8c6e…
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 Anti-Itch
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CAMPHOR (SYNTHETIC) .5 g/100g MENTHOL .5 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5TJD82A1ET Internal UNII lookup L7T10EIP3A Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70000-0546-1 Leader Anti-Itch 212 g in 1 BOTTLE, PUMP LOTION 212 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70000-0546 LEADER ANTI-ITCH (CAMPHOR, MENTHOL) LOTION [LEADER/CARDINAL HELATH 110, INC.] 6 Current NDC, Legacy NDC, 1 package rows 20241208_9ca985c6-5017-0558-e053-2995a90a8202.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 12 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Natures Willow Balm Roll On Pain Relief MENTHOL WB Ventures LLC 3b1834e6-75cd-5380-e063-6294a90ad1d5 2026-07-08 Warnings Exact identifier application number: M017 Natures Willow Balm Itch Relief Cream MENTHOL WB Ventures LLC 0ce31b5d-4401-460c-e063-6394a90ab558 2026-07-08 Warnings Exact identifier application number: M017 CAREALL Hydrocortisone Maximum Strength HYDROCORTISONE New World Imports, Inc. 560a4abf-31dd-333f-e063-6294a90a3505 2026-07-08 Warnings Exact identifier application number: M017 Natures Willow Balm MENTHOL WB VENTURES LLC b9f50c43-b0d5-39a8-e053-2995a90a04f1 2026-07-08 Warnings Exact identifier application number: M017 Natures Willow Bug Bite Balm MENTHOL WB Ventures LLC b9fab18f-32c7-d5bd-e053-2995a90a6d0f 2026-07-08 Warnings Exact identifier application number: M017 Salonpas pain relieving hot CAPSAICIN, MENTHOL Hisamitsu Pharmaceutical Co., Inc. d2aa8820-a947-404b-b617-e692fbd16502 2026-07-07 Warnings Exact identifier application number: M017 Quali Yi Tiao Gen Pain Patch CAPSAICIN PATCH Sheng Chang Pharmaceutical Co, Ltd. Zhongli Factory 33154a9b-f6d0-4e95-b4cb-6b938f5dcf4d 2026-07-07 Warnings Exact identifier application number: M017 MUYOHON Numbing Cream NUMBING CREAM Guangzhou Jingliang Cosmetics Co., Ltd. 55caf0a5-f062-a6c3-e063-6294a90ae073 2026-07-04 Warnings Exact identifier application number: M017 Targeted Warming Capsaicin Patch CAPSAICIN Army & Air Force Exchange Service 55b539f8-38c4-594e-e063-6394a90afbaa 2026-07-03 Warnings Exact identifier application number: M017 TopCare Health Pain Relief LIDOCAINE HYDROCHLORIDE Topco Associates LLC 485b0671-da09-19d7-e063-6294a90aca5d 2026-07-03 Warnings Exact identifier application number: M017 Mineral Ice Methol Pain Relief MENTHOL 10.5 % Sunflora Inc 6ddd9e97-f717-4d5a-9658-26449a3cc831 2026-07-02 Warnings Exact identifier application number: M017 Burn Relief LIDOCAINE AmerisourceBergen Drug Corporation 7d898e33-ded7-c9b9-e053-2a91aa0adf7c 2026-07-01 Warnings Exact identifier application number: M017 Desert Harvest Releveum with Lidocaine LIDOCAINE HYDROCHLORIDE Desert Harvest, Inc 9ad514ab-a6bd-4564-8ba3-0149032ebf36 2026-07-01 Warnings Exact identifier application number: M017 CVS No Mess Cortisone HYDROCORTISONE Natural Essentials, Inc. 558c94ec-95f1-eb98-e063-6394a90a1e72 2026-07-01 Warnings Exact identifier application number: M017 MUSCLE EASE MENTHOL CAMPHOR SOMBRA COSMETICS INC. 03fff4bf-04ed-49a6-b40f-4d98c2b42f69 2026-07-01 Warnings Exact identifier application number: M017 OrthoNesic Pain Relieving Gel MENTHOL, CAMPHOR Blaine Labs Inc. 122f60c2-f8df-4625-8bb8-a2244a261b5d 2026-07-01 Warnings Exact identifier application number: M017 Desert Harvest RELEVEUM LIDOCAINE Desert Harvest Inc. 5d9010ec-d482-44ff-ba27-3bfec5a241c6 2026-06-30 Warnings Exact identifier application number: M017 Promescent LIDICAINE Absorption 5b508238-3be7-4b0d-bf35-51de79f58f55 2026-06-30 Warnings Exact identifier application number: M017 Lidovyx LIDOCAINE 4% V2 Pharma LLC 4465eb60-a617-4608-9504-8b3b4c64f49e 2026-06-30 Warnings Exact identifier application number: M017 Dr.Johnes Lidocaine 4% Topical Analgesic Cream LIDOCAINE HCL,MENTHOL Dr.Johnes LLC 6144708d-4b0f-4f0d-88e3-6925ba2d004d 2026-06-29 Warnings Exact identifier application number: M017
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70000-0546-1 70000054601 212 g in 1 BOTTLE, PUMP (70000-0546-1) 212 g 2020-01-21 0000-00-00 No No Current