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 |
|---|---|---|---|---|---|---|
| PROINNATE Numbing Cream | MENTHOL | Guangzhou Haishi Biological Technology Co., Ltd. | 40c63645-8ed3-82b3-e063-6294a90a5267 | 2025-10-13 | Warnings | M017 |
| Cramergesic | MENTHOL, METHYL SALICYLATE | The Hygenic Company, LLC | d0ffde7a-6942-74fc-e053-2a95a90a484a | 2025-10-13 | Warnings | M017 |
| Tricylate | MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE | Trifluent Pharma LLC | 4869b63a-e01e-4a79-a493-7a1b4d3e914b | 2025-10-13 | Warnings | M017 |
| Doloflex Pain Relief | MENTHOL, METHYL SALICYLATE | United Health & Beauty Corp | 32a830cc-04d3-102e-e063-6294a90a1cad | 2025-10-12 | Warnings | M017 |
| Lidocaine Pain Relieving Gel-Patch | LIDOCAINE | Nanjing Anxing Medical Technology Co., Ltd. | 40c9b132-57ce-865e-e063-6394a90a2080 | 2025-10-10 | Warnings | M017 |
| Kinesys | ZINC OXIDE | Wilc Healthcare Inc | a32b44c3-eda0-48ea-95fc-250a2c2396ca | 2025-10-10 | Warnings | M017 |
| Te-Fu Recovery Massage | MENTHOL, METHYL SALICYLATE | Wasatch Product Development | 7bc2989f-dfb6-e8af-e053-2991aa0a0bf2 | 2025-10-10 | Warnings | M017 |
| Anti-itch | HYDROCORTISONE | Medline Industries, LP | b0947381-c0db-4253-ab40-3d45603ae65d | 2025-10-09 | Warnings | M017 |
| Kalaya Pain Relief | METHYL SALICYLATE, MENTHOL, CAMPHOR | Avaria Health & Beauty Corp | e2452c4b-2548-497f-828b-5d960402522a | 2025-10-08 | Warnings | M017 |
| Kalaya Pain Relief 6X with Arnica | PAIN RELIEF CREAM | Avaria Health & Beauty Corp | 60198d2e-4de3-3fa0-e053-2a91aa0afaf7 | 2025-10-08 | Warnings | M017 |
| KALAYA PAIN RELIEF 6X WITH ARNICA - Pain Relief | METHYL SALICYLATE, MENTHOL, CAMPHOR | Avaria Health & Beauty Corp | 9b9b7cad-a5e2-4445-856b-4aa439d77a80 | 2025-10-08 | Warnings | M017 |
| KALAYA FOAMING PAIN RELIEF | METHYL SALICYLATE, MENTHOL, CAMPHOR | Avaria Health & Beauty Corp | d5021e6d-f29f-446b-874c-bdcabd9cf4f6 | 2025-10-08 | Warnings | M017 |
| KALAYA EXTRA STRENGTH FOAMING PAIN RELIEF | METHYL SALICYLATE, MENTHOL, CAMPHOR | Avaria Health & Beauty Corp | e0c9f22a-165a-4558-ba3c-8592f1bd0016 | 2025-10-08 | Warnings | M017 |
| Kalaya Extra Strength Pain Relief Cream with Hemp Seed Oil | METHYL SALICYLATE, MENTHOL, CAMPHOR | Avaria Health & Beauty Corp | 2eccf23c-fae2-423c-9cae-549bc4194104 | 2025-10-08 | Warnings | M017 |
| KALAYA BACK AND NECK PAIN RELIEF | METHYL SALICYLATE, MENTHOL, CAMPHOR | Avaria Health & Beauty Corp | 48fd73e7-1443-4ac7-bf7c-d99bf2449f51 | 2025-10-08 | Warnings | M017 |
| Lidocaine Pain Relieving Patch | LIDOCAINE 4% | BluePoint Laboratories | 3117273d-e006-2726-e063-6294a90a9c33 | 2025-10-08 | Warnings | M017 |
| EQUATE PAIN RELIEVING PATCHES | LIDOCAINE 4% | WALMART, INC | 01e1cc0e-e1c9-d274-e063-6294a90a409e | 2025-10-08 | Warnings | M017 |
| Equate Pain Relief Balm | MENTHOL 11%, CAMPHOR 11% OINTMENT | WALMART, INC | d8ddf835-f008-ce1f-e053-2a95a90aa9b3 | 2025-10-08 | Warnings | M017 |
| TheraCare Pain Relieving Menthol Gel | MENTHOL 2% | Veridian Healthcare | 9d2ccb02-746c-4cb9-905d-280987778f4d | 2025-10-08 | Warnings | M017 |
| COOLING PAIN RELIEF | MENTHOL, CAMPHOR | SUNSET NOVELTIES, INC | 3a9019b1-8798-1ef9-e063-6394a90a09a4 | 2025-10-08 | 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 |