Methyl Salicylate 25% Cream
- Product NDC
- 80425-0544
- 11-digit product format
- 804250544
- Labeler code
- 80425
- Product ID
- 80425-0544_3bdd3021-d16d-12ea-e063-6394a90ab1e0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Methyl Salicylate
- Dosage form
- CREAM
- Route
- CUTANEOUS
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-08-08
- Substance
- METHYL SALICYLATE
- Active strength
- 250 mg/g
- 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
- Methyl Salicylate 25% Cream
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| METHYL SALICYLATE | 250 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| LAV5U5022Y | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 238542 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3bdd3015-349a-0fac-e063-6394a90afe41 | 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 |
|---|---|---|---|---|---|---|
| 80425-0544-1 | Methyl Salicylate 25% Cream | 120 g in 1 TUBE | CREAM | 120 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0544-1 | GM - Gram | 80425-0544 | a501e4a7-b11a-4bea-8338-523a961cfc7f | 1 | 2025-09-12 |
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 |
|---|---|---|---|---|---|---|
| IKONIK TONIK | LIDOCAINE HYDROCHLORIDE | IKONIK CARE, LLC | 122fdfe8-b5fa-46d1-9fd9-3df9887ed320 | 2025-01-14 | Warnings | M017 |
| elp essential MANTECA DE UBRE | METHYL SALICYLATE, CAMPHOR | Miramar Cosmetics, Inc DBA Miramar Lab | c3964dfe-17fe-4d89-a4c4-cf500f982259 | 2025-01-13 | Warnings | M017 |
| Methylten | METHYL SALICYLATE 10% | Puretek Corporation | 28f4093f-803f-0e70-e063-6294a90a98a4 | 2025-01-13 | Warnings | M017 |
| Refill Bundle 7 Large Office | BENZALKONIUM CHLORIDE | CMC Group, Inc. | 6620a8f3-098d-d045-e053-2a91aa0a0d94 | 2025-01-13 | Warnings | M017 |
| Jakwork Numbing Cream | NUMBING CREAM | Guangzhou Zanming Trading Co., Ltd. | 2ba1de83-494a-6c54-e063-6294a90a9b2d | 2025-01-13 | Warnings | M017 |
| Arthritis Hot | MENTHOL AND METHYL SALICYLATE | Chattem, Inc. | cc57b9b6-8ba5-4ff3-a5df-97d8f5b1bebd | 2025-01-13 | Warnings | M017 |
| Re-Lieved Lidocaine Patch | LIDOCAINE PATCH 4% | Transfer Technology | 00b40dda-53ad-0458-e063-6394a90aa835 | 2025-01-11 | Warnings | M017 |
| Re-Lieved Lidocaine Patch | LIDOCAINE PATCH 4% | Transfer Technology | 00b47eb7-6b43-d9e2-e063-6294a90a9a38 | 2025-01-11 | Warnings | M017 |
| Re-Lieved 4% Lidocaine Fabric Tape | LIDOCAINE 4% FABRIC TAPE | Transfer Technology | e9a894b0-54f2-707e-e053-2a95a90a0f0d | 2025-01-11 | Warnings | M017 |
| Re-Lieved 3 in 1 Patch | MENTHOL, CAMPHOR, METHYL SALICYLATE PATCH | Transfer Technology | e9ab9a03-b9e3-7317-e053-2995a90a9950 | 2025-01-11 | Warnings | M017 |
| ASTRAPHARM CHILLI BRAND | CAPSAICIN | Dersan Pharmaceutical Co., Ltd | b4c2d4fd-7d5d-4156-ac27-e72ebc9671ec | 2025-01-10 | Warnings | M017 |
| 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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 238542 | methyl salicylate 25 % Topical Cream | PSN | 3bdd3015-349a-0fac-e063-6394a90afe41 | 1 |
| 238542 | methyl salicylate 250 MG/ML Topical Cream | SCD | 3bdd3015-349a-0fac-e063-6394a90afe41 | 1 |
| 238542 | methyl salicylate 25 % Topical Cream | SY | 3bdd3015-349a-0fac-e063-6394a90afe41 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 80425-0544-1 | 80425054401 | 120 g in 1 TUBE (80425-0544-1) | 120 g | 2025-08-08 | No | No | Current |