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 |
|---|---|---|---|---|---|---|
| itch relief | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | H E B | 34c7bcd3-203f-4630-894d-3739a1576c8d | 2024-10-13 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | H E B | 25ec9014-64c4-44df-9e67-9f9223ffc923 | 2024-10-12 | Warnings | M017 |
| PAIN RELIEF Gel-Roll On | LIDOCAINE AND MENTHOL | Shanghai Chuangshi Medical Technology (Group) Co., Ltd. | f02fa9c0-b8af-f362-e053-2a95a90ae516 | 2024-10-11 | Warnings | M017 |
| Insect Sting Relief Pad | BENZOCAINE, ALCOHOL | Hubei Changjian Medical Products Co., Ltd. | 6a269982-0e25-4c09-aef1-0b398bdc5ed4 | 2024-10-11 | Warnings | M017 |
| HYDROCORTISONE | HYDROCORTISONE | VIVE HEALTH LLC | 24221805-e5c9-5785-e063-6394a90a9d2f | 2024-10-10 | Warnings | M017 |
| De La Cruz Camphor | CAMPHOR | DLC Laboratories, Inc. | 62359237-de2d-4497-bfd6-36991cfc8acf | 2024-10-10 | Warnings | M017 |
| Anti Itch | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | Meijer Distribution Inc | 4f536a86-6419-4ab0-a7e8-5c37943823e2 | 2024-10-09 | Warnings | M017 |
| terrasil Bruise and Pain Relief Maximum Strength | CAMPHOR, MENTHOL | Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions | 240b231d-a8b2-c64c-e063-6394a90a7440 | 2024-10-09 | Warnings | M017 |
| Muscle Freeze Relief | MENTHOL | NATURAL ESSENTIALS, INC. | 815c534b-096d-49f2-b5f2-8c885d45a5e6 | 2024-10-09 | Warnings | M017 |
| HYDROCORTISONE | HYDROCORTISONE | VIVE HEALTH LLC | 2410dc2f-9332-19fa-e063-6394a90a2835 | 2024-10-09 | Warnings | M017 |
| CVS Health Lidocaine Pain-Relieving | LIDOCAINE | Natural Essentials, Inc. | fc23b2e2-4abc-4119-b8bd-305b4327f1dd | 2024-10-09 | Warnings | M017 |
| KERACARE | MENTHOL 1% | Avlon Industries, Inc. | f72eec6d-1204-4e03-8aed-d5bcf8d3bbce | 2024-10-09 | Warnings | M017 |
| Eagle Medicated | MENTHOL METHYL SALICYLATE | Eagle Indo Pharma, PT | da338796-de9c-be51-e053-2a95a90a2509 | 2024-10-07 | Warnings | M017 |
| Eagle Medicated | MENTHOL METHYL SALICYLATE | Eagle Indo Pharma | e2c5f821-cdd5-190d-e053-2a95a90a9159 | 2024-10-07 | Warnings | M017 |
| NanoXtreme Pain Relieving | MENTHOL, METHYL SALICYLATE | MG Science Technologies LLC | c1490c30-a9db-4120-adaf-9e8000169e46 | 2024-10-07 | Warnings | M017 |
| CAREALL Hydrocortisone Maximum Strength | HYDROCORTISONE | New World Imports, Inc | ea656cf8-cad5-4fa5-82e7-daec77a0bb04 | 2024-10-07 | Warnings | M017 |
| Eagle Medicated Oil Refreshing | MENTHOL, METHYL SALICYLATE | Eagle Indo Pharma, PT | e2729023-d689-7ae2-e053-2a95a90a78dc | 2024-10-06 | Warnings | M017 |
| Flanax Back Pain Relief | LIDOCAINE | Belmora LLC | 46d33346-e582-4af1-b81a-feca7033dceb | 2024-10-04 | Warnings | M017 |
| Muscle Balm | MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC) | Natural Essentials, Inc. | 16918ba3-2e07-4232-9ed3-4c7751796cd2 | 2024-10-04 | Warnings | M017 |
| Fast Freeze Pain Relieving Continuous | MENTHOL, UNSPECIFIED FORM | Natural Essentials, Inc. | 998a4824-9ed9-4fe0-b45b-72e52861fcd3 | 2024-10-04 | 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 |