Rugged Fit Pain Relief Roll On
- Product NDC
- 85826-041
- 11-digit product format
- 858260041
- Labeler code
- 85826
- Product ID
- 85826-041_3b4e500e-32b7-6ec6-e063-6294a90aea6e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Menthol, Methyl Salicylate
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- SYSTEM4BOOK LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-06-27
- Substance
- MENTHOL; METHYL SALICYLATE
- Active strength
- 2; 10 g/100mL; g/100mL
- 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
- Rugged Fit Pain Relief Roll On
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL | 2 g/100mL |
| METHYL SALICYLATE | 10 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
| LAV5U5022Y | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2711803 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 39d68734-981c-14d7-e063-6294a90a4919 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85826-041-10 | Rugged Fit Pain Relief Roll On | 100 mL in 1 BOTTLE | GEL | 100 | 2 |
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 |
|---|---|---|---|---|---|---|
| LABOFLEX Lidocaine Pain Relieving Patch | LIDOCAINE 4% | Laboflex, Inc. | 31995f31-c272-afdb-e063-6294a90af3f9 | 2025-01-10 | Warnings | M017 |
| Anti-Itch Cream | DIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1% | Chain Drug Marketing Association Inc. | 2b48cb2f-e6bf-f9de-e063-6394a90a42d4 | 2025-01-09 | Warnings | M017 |
| PAIN-X | MENTHOL | OL PHARMA TECH,LLC | b22bb19a-14e5-3d32-e053-2a95a90ae520 | 2025-01-09 | Warnings | M017 |
| MUSCLE RUB | MENTHOL | OL PHARMA TECH,LLC | b22c7999-52d5-25c3-e053-2a95a90a01f5 | 2025-01-09 | Warnings | M017 |
| Biofreeze Professional Colorless Roll-On | MENTHOL, UNSPECIFIED FORM | A-S Medication Solutions | ce392c4f-cc43-484d-9c49-18fa25e4e5e9 | 2025-01-09 | Warnings | M017 |
| NEW TEROCIN | METHYL SALICYLATE, CAPSAICIN, AND MENTHOL | A-S Medication Solutions | 43e5eb27-5541-4b7b-80de-55a79a4dce55 | 2025-01-09 | Warnings | M017 |
| Biofreeze Professional | MENTHOL, UNSPECIFIED FORM | A-S Medication Solutions | cbeac814-59d8-4c13-8e73-bca66f797f8d | 2025-01-09 | Warnings | M017 |
| Bactine Max | LIDOCAINE | WellSpring Pharmaceutical Corporation | acd7ae37-7c42-4ec7-a2ef-42e7f628388d | 2025-01-08 | Warnings | M017 |
| THERABLAST MAXIMUM RELIEF | LIDOCAINE, MENTHOL | Releaf Technologies LLC | 09809985-3a88-9bb7-e063-6394a90a2f5f | 2025-01-08 | Warnings | M017 |
| ANTI ITCH | HYDROCORTISONE | Safeway | 0bfa1653-76b7-48ed-a896-a0b5fc3bd794 | 2025-01-08 | Warnings | M017 |
| Sting Relief Swab | BENZOCAINE | Epic Medical Supply Corp | 259fbfe4-d67c-ea1e-e063-6294a90a0fb0 | 2025-01-07 | Warnings | M017 |
| Sinsin Mulpas | CAMPHOR, MENTHOL, METHYL SALICYLATE | Sinsin Pharmaceutical Co., Ltd. | 22ea8a51-fdee-4650-abf8-f996268c9303 | 2025-01-07 | Warnings | M017 |
| SINSINPAP COOL | LEVOMENTHOL, THYMOL, CAMPHOR, MENTHA, EUCALYPTUS | Sinsin Pharmaceutical Co., Ltd. | 9d47855f-ccb5-4557-a31a-a2b336fa9806 | 2025-01-07 | Warnings | M017 |
| Burn Jel | LIDOCAINE HYDROCHLORIDE | Water-Jel Technologies | ff621b46-2342-41db-994d-851a09796d08 | 2025-01-06 | Warnings | M017 |
| Lidocare Arm, Neck, Leg | 4% LIDOCAINE | Kingsway Pharmaceuticals dba NFI, LLC | 59a104ee-7034-99c3-e053-2991aa0a164c | 2025-01-06 | Warnings | M017 |
| Salonpas LIDOCAINE Pain Relieving | LIDOCAINE | Hisamitsu Pharmaceutical Co., Inc. | 4f3a438c-f378-4d2a-a95c-58e56cf1e797 | 2025-01-06 | Warnings | M017 |
| Lidocare 03 | 4% LIDOCAINE | Kingsway Pharmaceuticals dba NFI, LLC | 416ebf5a-2efb-6d0b-e054-00144ff88e88 | 2025-01-06 | Warnings | M017 |
| AVCOO Pain Relief Roll-on | MENTHOL | ADP Health Limited | e0bb77b2-45ee-45fa-9659-9c7d99bb20dc | 2025-01-05 | Warnings | M017 |
| health and beyond BURN | LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | 0b6bb3ed-50fb-40c4-acb6-ae3f16031531 | 2025-01-05 | Warnings | M017 |
| glo SKIN BEAUTY Remedy Gel | GLO SKIN BEAUTY REMEDY GEL | Hayden Caleel LLC | aa47ff08-07b3-4fd1-bae5-420e4b928f06 | 2025-01-05 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2711803 | menthol 2 % / methyl salicylate 10 % Topical Gel | PSN | 39d68734-981c-14d7-e063-6294a90a4919 | 2 |
| 2711803 | menthol 0.02 MG/MG / methyl salicylate 0.1 MG/MG Topical Gel | SCD | 39d68734-981c-14d7-e063-6294a90a4919 | 2 |
| 2711803 | menthol 2 % / methyl salicylate 10 % Topical Gel | SY | 39d68734-981c-14d7-e063-6294a90a4919 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85826-041-10 | 85826004110 | 100 mL in 1 BOTTLE (85826-041-10) | 100 ml | 2025-06-27 | No | No | Current |