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
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 70000-0546 | D | Discontinued by firm | 2026-10-23 | ||
| excluded package | package | 70000-0546 | 70000-0546-7 | D | Discontinued by firm | 2026-10-23 |
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.
| 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 |
|---|---|
| CAMPHOR (SYNTHETIC) | .5 g/100g |
| MENTHOL | .5 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5TJD82A1ET | Internal UNII lookup |
| L7T10EIP3A | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9ca985c6-5017-0558-e053-2995a90a8202 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70000-0546-1 | 2024-01-04 | C162847 | 48780-1 | f386c64a-37ea-0266-e053-dadaa90a7c1a | Leader Original Anti Itch Lotion |
| 70000-0546-1 | 2023-01-30 | C162847 | 48780-1 | f386c64a-37ea-0266-e053-dadaa90a7c1a | Leader Original Anti Itch Lotion |
DailyMed Package Descriptions#
| 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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70000-0546-1 | ML - Milliliter | 70000-0546 | b2398c74-4403-44a7-90c3-99f5bae4f75a | 1 | 2020-06-05 |
DailyMed Dashboard NDC Coverage#
| 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Joint and Muscle Relief | MENTHOL | Smart Cookie Solutions Inc. | 45c24d56-4dc9-2884-e063-6294a90a52cc | 2025-12-12 | Warnings | M017 |
| Popstar | DELAY SPRAY | Pineapple Brands LLC | 293b2da9-1261-0358-e063-6394a90aa08c | 2025-12-12 | Warnings | M017 |
| Careland Pain Relief Plus | CAMPHOR, MENTHOL, METHYL SALICYLATE | Planet (Anhui) Pharmaceutical Co., Ltd. | d9e63ddd-d003-45fa-b156-7f4452c28cbd | 2025-12-12 | Warnings | M017 |
| Glucosamine Cream EXTRA STRENGTH | HISTAMINE DIHYDROCHLORIDE | IDEAZ, LLC | f4d414b7-89e7-ad65-e053-2a95a90a25d4 | 2025-12-12 | Warnings | M017 |
| ARTHRITIS | MENTHOL | Smith Amish, LLC | 20c36972-b695-1241-e063-6394a90adf63 | 2025-12-12 | Warnings | M017 |
| FOOT | MENTHOL | Smith Amish, LLC | 20c48537-f55f-c10f-e063-6394a90a4cca | 2025-12-12 | Warnings | M017 |
| Joint Ease | MENTHOL | Smith Amish, LLC | 20c4a0f8-bdc6-d89a-e063-6294a90aa8d8 | 2025-12-12 | Warnings | M017 |
| Toast Screamin Hot | CAPSAICIN | IDEAZ, LLC | 331207e6-b8ac-b169-e063-6394a90ac169 | 2025-12-12 | Warnings | M017 |
| Pain Relief Gel-Patch | LIDOCAINE | KORVIA GLOBAL Inc. | 45ccfcae-a307-1c5f-e063-6294a90acf89 | 2025-12-12 | Warnings | M017 |
| Lidospot patch | LIDOCAINE AND MENTHOL | Fabrication Enterprises Inc | 3a6e94c4-1ca6-e77a-e063-6394a90a4bfc | 2025-12-12 | Warnings | M017 |
| LETEBEE LIGHT neuropathy pain relief cream for feet | MENTHOL | Guangdong Aimu Biological Technology Co., Ltd | 45a99afc-15ec-76c2-e063-6294a90a2220 | 2025-12-11 | Warnings | M017 |
| Cinthera | LIDOCAINE | Strand Health Group | 2746e5b2-be2d-f2d2-e063-6394a90a3690 | 2025-12-11 | Warnings | M017 |
| Equate Cool and Heat Pain Relieving Liquid | COOL AND HEAT PAIN RELIEF | Walmart, Inc. | ad156685-3bd5-6837-e053-2995a90ac788 | 2025-12-11 | Warnings | M017 |
| HUMCO Camphor Spirit | CAMPHOR 10% | Humco Holding Group, Inc. | 9a0ef0a3-3c79-41b2-8193-424a3ef9886f | 2025-12-11 | Warnings | M017 |
| T-Relief Lidocaine HCL 4% | LIDOCAINE HCL 4% | Medinatura New Mexico Inc. | 3c19aff8-fb18-78d0-e063-6294a90a9481 | 2025-12-11 | Warnings | M017 |
| Jointiva | TROLAMINE SALICYLATE 10% | Rising Pharma Holdings, Inc. | 3ee33cbf-7c0f-4982-b0b6-eeeb0202803b | 2025-12-11 | Warnings | M017 |
| LMX4 | LIDOCAINE | Ferndale Laboratories, Inc. | f0e7c92f-8b0b-4045-b659-af9f6e81260f | 2025-12-10 | Warnings | M017 |
| HurriCaine One | TOPICAL ANESTHETIC AND ANTISEPTIC | Beutlich Pharmaceuticals LLC | 459cedbd-9b6f-e450-e063-6394a90afb73 | 2025-12-10 | Warnings | M017 |
| AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 3 | NICOTINE TRANSDERMAL PATCHES | PCHEERY LLC | 45811e83-8d0b-bc2a-e063-6294a90adf50 | 2025-12-09 | Warnings | M017 |
| AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 2 | NICOTINE TRANSDERMAL PATCHES | PCHEERY LLC | 4580d7f0-92a9-d0d0-e063-6394a90ac393 | 2025-12-09 | Warnings | M017 |
Packages#
| 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 |