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 |
|---|---|---|---|---|---|---|
| Coralite Capsaicin Heat Patch 2ct | CAPSAICIN | United Exchange Corp. | 4128b1ac-f540-2611-e063-6294a90ac98b | 2025-10-08 | Warnings | M017 |
| Ombre Men overtime wipes | BENZOCAINE | Sambria Pharmaceuticals, LLC | 405f23ca-99c1-4db4-aba1-2fd7f93f55ee | 2025-10-07 | Warnings | M017 |
| Pain free IV | LIDOCAINE | Sambria Pharmaceuticals, LLC | 7aa4cb20-d452-417f-afdb-307df754ed75 | 2025-10-07 | Warnings | M017 |
| HYDROCORTISONE | HYDROCORTISONE | CVS PHARMACY, INC | b3bdff5e-37fe-442a-a370-7b19799ea781 | 2025-10-07 | Warnings | M017 |
| HealthWise Pain Relief Patch | MENTHOL, METHYL SALICYLATE | Veridian Healthcare | b65932fd-ee9f-4fa2-b842-01e0f54133c9 | 2025-10-07 | Warnings | M017 |
| AREX SINSIN PAS | CAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDE | Sinsin Pharmaceutical Co., Ltd. | 2013ea44-e2ea-4b36-bddb-7f64163284b6 | 2025-10-07 | Warnings | M017 |
| SINSINPAS LIDOCAINE PAIN RELIEVING | LIDOCAINE | Sinsin Pharmaceutical Co., Ltd. | 82c0a036-8750-5b3d-e053-2a91aa0a1815 | 2025-10-07 | Warnings | M017 |
| SINSIN MULPAS | L-MENTHOL, METHYL SALICYLATE, DL-CAMPHOR, CHLORPHENIRAMINE MALEATE, THYMOL | Sinsin Pharmaceutical Co., Ltd. | 81baffcb-c08e-4616-e053-2a91aa0aaf15 | 2025-10-07 | Warnings | M017 |
| Arex Sinsin Pas | CAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDE | Sinsin Pharmaceutical Co., Ltd. | a851854a-5dfe-4bd5-95f6-67c3f13f1187 | 2025-10-07 | Warnings | M017 |
| Sinsinpas Arex Flex Gel Pain Relieving Patch | L-MENTHOL | Sinsin Pharmaceutical Co., Ltd. | 1758ef9b-4fac-4066-e063-6394a90a8cc3 | 2025-10-07 | Warnings | M017 |
| SINSINPAS CORN REMOVER | SALICYLIC ACID | Sinsin Pharmaceutical Co., Ltd. | e2771dfc-ee57-553f-e053-2a95a90af281 | 2025-10-07 | Warnings | M017 |
| Feminine Anti-Itch Creme | BENZOCAINE, RESORCINOL | Quality Choice (CHAIN DRUG MARKETING ASSOCIATION) | aa6cc963-dc60-5222-e053-2995a90acaf6 | 2025-10-06 | Warnings | M017 |
| TheraCare 2% Diphenhydramine Anti-Itch Cream | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Veridian Healthcare | 5999b677-63dd-49c6-b5b8-7b3c117ecc5c | 2025-10-06 | Warnings | M017 |
| HealthWise Pain Relief | MENTHOL | Veridian Healthcare | 06be5331-7a1e-4ab3-9f17-2d350bd4b890 | 2025-10-02 | Warnings | M017 |
| equate Burn Relief | LIDOCAINE HYDROCHLORIDE | Walmart Inc | a90cbd92-80a5-4463-8152-b83165121a6f | 2025-10-02 | Warnings | M017 |
| AsperFlex HOT | CAMPHOR, MENTHOL, METHYL SALICYLATE | Akron Pharma Inc. | a6cb0656-8866-44ff-b40c-73655ff68721 | 2025-10-02 | Warnings | M017 |
| AsperFlex Original Maximum Strength | MENTHOL | Akron Pharma Inc. | d766c61e-c48b-4aff-97b0-678159479e03 | 2025-10-02 | Warnings | M017 |
| HealthWise Feminine Anti-Itch Cream | BENZOCAINE, RESORCINOL | Veridian Healthcare | 1f9110da-f448-8e20-e063-6294a90a4275 | 2025-10-02 | Warnings | M017 |
| PROSTAT FIRST AID Burn Ease, 0.9g | LIDOCAINE | ProStat First Aid LLC | dc704403-e2aa-47f7-a7f4-f6afe1547ca8 | 2025-10-01 | Warnings | M017 |
| PROSTAT FIRST AID Burn Ease, 0.9g | LIDOCAINE | ProStat First Aid LLC | e02558a9-fe2b-4f28-9fd3-7308f859d759 | 2025-10-01 | 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 |