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 |
|---|---|
| MENTHOL, UNSPECIFIED FORM | 40 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 415974 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e86cba40-6b10-454d-98b3-6b547456eaad | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70000-0617-1 | Leader Roll-On Cooling Pain ReliefTopical Analgesic | 74 mL in 1 BOTTLE, WITH APPLICATOR | GEL | 74 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70000-0617-1 | ML - Milliliter | 70000-0617 | f70d2da2-16df-4ecc-a8b1-b3f0ca99efe8 | 1 | 2023-04-07 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70000-0617 | LEADER ROLL-ON COOLING PAIN RELIEF TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM) GEL [CARDINAL HEALTH, 110 DBA LEADER] | 2 | Current NDC, Legacy NDC, 1 package rows | 20240302_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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Coralite Ultra Strength Pain Relief | CAMPHOR MENTHOL | United Exchange Corp. | 44ecf959-cc07-4adc-a500-075b2ee69548 | 2025-10-29 | Warnings | M017 |
| GoodSense Pain Relief | LIDOCAINE | Geiss, Destin & Dunn, Inc | 826f8da4-8468-ea0a-e053-2991aa0a66cb | 2025-10-28 | Warnings | M017 |
| CALMADOL | CAMPHOR, MENTHOL, METHYL SALICYLATE | GRANDALL DISTRIBUTING, LLC | 31b7f84e-8b66-4d31-8e9c-279d0af2fe64 | 2025-10-28 | Warnings | M017 |
| XRay DOL | CAMPHOR, MENTHOL, AND METHYL SALICYLATE | Genomma Lab USA, Inc. | e07fef46-68d9-769c-e053-2a95a90aa065 | 2025-10-28 | Warnings | M017 |
| CVS Medicated Heat | CAPSICUM EXTRACT | CVS Pharmacy | 81cd1019-93a6-311b-e053-2991aa0a7997 | 2025-10-28 | Warnings | M017 |
| Foster and Thrive | LIDOCAINE | STRATEGIC SOURCING SERVICES, LLC | f950b072-d978-b629-e053-6394a90abfaf | 2025-10-28 | Warnings | M017 |
| Calamine Plus Pramoxine HCl | CALAMINE PLUS SPRAY | Premier Brands of America, Inc. | d3452573-f91f-f157-e053-2a95a90a1ad8 | 2025-10-27 | Warnings | M017 |
| PR | MENTHOL | Amphp, Inc | 6f5b9e08-c445-4fac-e053-2a91aa0aa737 | 2025-10-27 | Warnings | M017 |
| Lidocaine | BURN RELIEF | Foodhold USA | b25dc0df-02d0-41ac-b36c-2c04baa77ef2 | 2025-10-27 | Warnings | M017 |
| Menthol | MAXIMUM STRENGTH MEDICATED FOOT POWDER TALC FREE | FSA Store Inc. | fb3548c8-f202-dc50-e053-6394a90a5b30 | 2025-10-27 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE CONTINUOUS SPRAY | Premier Brands of America, Inc. | d344f68b-9b62-3029-e053-2995a90a1665 | 2025-10-27 | Warnings | M017 |
| Medi-First Hydrocortisone 1% | HYDROCORTISONE ACETATE 1% | Unifirst First Aid Corporation | f2b46d69-1c21-5ae9-e053-2a95a90a60a9 | 2025-10-24 | Warnings | M017 |
| Extra Strength | MENTHOL AND METHYL SALICYLATE | Saje Natural Business Inc. | 87d872b3-3231-d0f2-e053-2995a90a9d98 | 2025-10-24 | Warnings | M017 |
| Coralite Muscle and Joint Pain Relief | CAMPHOR, MENTHOL, AND MEHTYL SALICYLATE | United Exchange Corporation | 78edeeb8-3e3c-64bb-e053-2a91aa0a7bbc | 2025-10-24 | Warnings | M017 |
| Coralite Odor Free Pain Relief | LIDOCAINE | United Exchange Corporation | 7966d9f2-22f9-a900-e053-2991aa0aba55 | 2025-10-24 | Warnings | M017 |
| Signature Care Cold and Hot | MENTHOL, AND METHYL SALICYLATE | Safeway Inc. | ab201023-e3dc-52ec-e053-2995a90a1f18 | 2025-10-24 | Warnings | M017 |
| HealthWise Medicated Cold Hot 5% Patch | MENTHOL | Veridian Healthcare | 15aef56f-cd25-05ac-e063-6394a90a07bb | 2025-10-23 | Warnings | M017 |
| Alivio | LIDOCAINE | Amerise Pharmaceuticals LLC | eb3a98f1-c875-4f08-8b4b-44e22626b609 | 2025-10-23 | Warnings | M017 |
| Pain Relieveing Gel-Patch | LIDOCAINE | Bullet point LLC | 41d507c4-ad37-2686-e063-6394a90aae5b | 2025-10-23 | Warnings | M017 |
| ActivICE | MENTHOL | Medline Industries, LP | 98fa9a34-0e1e-0997-e053-2a95a90ac77d | 2025-10-23 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 415974 | menthol 4 % Topical Gel | PSN | e86cba40-6b10-454d-98b3-6b547456eaad | 3 |
| 415974 | menthol 0.04 MG/MG Topical Gel | SCD | e86cba40-6b10-454d-98b3-6b547456eaad | 3 |
| 415974 | menthol 4 % Topical Gel | SY | e86cba40-6b10-454d-98b3-6b547456eaad | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70000-0617-1 | 70000061701 | 74 mL in 1 BOTTLE, WITH APPLICATOR (70000-0617-1) | 74 ml | 2022-11-03 | 0000-00-00 | No | No | Current |