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 |
|---|---|---|---|---|---|---|
| Burn Ease, 3.5g | BURN EASE, 3.5G | ProStat First Aid LLC | 004aa18f-3a97-f454-e063-6394a90afcff | 2025-12-15 | Warnings | M017 |
| PS-3866 Burn Ease, 0.9g | PS-3866 BURN EASE, 0.9G | ProStat First Aid LLC | 004d00a5-9cff-29ff-e063-6294a90aeb8c | 2025-12-15 | Warnings | M017 |
| First Aid Burn Cream | FIRST AID BURN CREAM | ProStat First Aid LLC | 0037a1a4-d747-2567-e063-6394a90a721c | 2025-12-15 | Warnings | M017 |
| PS-3885 Burn Ease, 3.5g | PS-3885 BURN EASE, 3.5G | ProStat First Aid LLC | 004c6deb-2844-a0d0-e063-6394a90ae5e4 | 2025-12-15 | Warnings | M017 |
| 2677 First Aid Burn Cream | 2677 FIRST AID BURN CREAM | ProStat First Aid LLC | ff5bb628-8ef7-4540-e053-6394a90a55ed | 2025-12-15 | Warnings | M017 |
| Burn Ease | BURN EASE | ProStat First Aid LLC | f71b98b4-22d0-0124-e053-6394a90ae4cf | 2025-12-15 | Warnings | M017 |
| Burn Ease | BURN EASE | ProStat First Aid LLC | f71eb4f5-2280-5867-e053-6394a90aac57 | 2025-12-15 | Warnings | M017 |
| Burn Ease 3.5g | BURN EASE 3.5G | Front Line Safety | 0f8e6842-c889-d5d3-e063-6394a90af880 | 2025-12-15 | Warnings | M017 |
| Burn Ease 3.5g | BURN EASE 3.5G | Front Line Safety | 0f8c59fb-3622-2bb7-e063-6294a90adc6e | 2025-12-15 | Warnings | M017 |
| Burn Ease | BURN EASE | Front Line Safety | 0e34cb09-d8c6-f8c0-e063-6294a90a0be0 | 2025-12-15 | Warnings | M017 |
| Burn Ease 3.5g | BURN EASE 3.5G | Front Line Safety | 0f52021f-af8a-5b95-e063-6294a90a2c2a | 2025-12-15 | Warnings | M017 |
| Burn Ease | BURN EASE | ProStat First Aid LLC | 0e25c936-e40a-e23c-e063-6294a90ac0e4 | 2025-12-15 | Warnings | M017 |
| Sting Relief Wipes | STING RELIEF WIPES | ProStat First Aid LLC | 0e20252a-5ecb-2526-e063-6294a90a8cde | 2025-12-15 | Warnings | M017 |
| First Aid Burn Cream | FIRST AID BURN CREAM | Front Line Safety | 0f4ce2c2-f306-d95f-e063-6394a90ae7b3 | 2025-12-15 | Warnings | M017 |
| Magsoothium Body | MENTHOL, CAPSAICIN | Ubu/Elements, Inc. | f604d30c-b17c-ec01-e053-2a95a90aa304 | 2025-12-15 | Warnings | M017 |
| Salonpas pain relieving JET | MENTHOL, METHYL SALICYLATE | Hisamitsu Pharmaceutical Co., Inc. | dd1ea3bf-891a-402e-8f43-14302bc9c3e5 | 2025-12-15 | Warnings | M017 |
| Herbal Tendon Bone Relief | CAMPHOR MINT | Guchutang Biotechnology (Longyan) Co., Ltd. | 45cf4040-9751-d24b-e063-6294a90aff27 | 2025-12-13 | Warnings | M017 |
| ElixirLidoFast | LIDOCAINE 5% CREAM | ELIXIR HEALTHCARE USA, LLC. | 45de5a3d-06c2-aa02-e063-6294a90a63d3 | 2025-12-13 | Warnings | M017 |
| MEDI FIRST PLUS | HYDROCORTISONE ACETATE | Orazen Inc | 5781124a-60f4-4a64-80b7-ce5f28d495b5 | 2025-12-12 | Warnings | M017 |
| MEDI-FIRST | HYDROCORTISONE ACETATE | Orazen Inc | aeffd85c-58a7-4d64-bf94-977b6fbbe713 | 2025-12-12 | 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 |