Methyl Salicylate 25 Percent
- Product NDC
- 50488-1016
- 11-digit product format
- 504881016
- Labeler code
- 50488
- Product ID
- 50488-1016_78bef856-b769-49ad-89af-8e46966e99ec
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Methyl Salicylate
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Alexso, Inc
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-05-01
- Substance
- METHYL SALICYLATE
- Active strength
- 250 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 Percent
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| METHYL SALICYLATE | 250 mg/mL |
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 |
|---|---|
| d8b8b0ba-69e9-4965-bf9b-6db21db69b34 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50488-1016-5 | Methyl Salicylate 25 Percent | 50 mL in 1 BOTTLE, PUMP | CREAM | 50 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50488-1016-5 | ML - Milliliter | 50488-1016 | bf43cf6a-cb28-4752-8ffa-6260e7ce7194 | 1 | 2024-08-12 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50488-1016 | METHYL SALICYLATE 25 PERCENT (METHYL SALICYLATE) CREAM [ALEXSO, INC] | 1 | Current NDC, 1 package rows | 20240522_d8b8b0ba-69e9-4965-bf9b-6db21db69b34.zip |
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 |
|---|---|---|---|---|---|---|
| Sheffield Arthritis and Muscle Pain Relief | CAPSICUM OLEORESIN | Sheffield Pharmaceuticals LLC | 724b9870-e86a-4087-ba78-8c944ce3baa6 | 2023-11-28 | Warnings | M017 |
| Dr Sheffield Muscle Rub Cream | MUSCLE RUB CREAM | Sheffield Pharmaceuticals LLC | 60d1d826-a53e-42e5-bc30-1b2c2690445b | 2023-11-28 | Warnings | M017 |
| Thera Plus Cold Therapy Pain Relieving Menthol | MENTHOL | Fourstar Group USA, Inc. | 0a462c91-5300-e282-e063-6394a90a4cc2 | 2023-11-27 | Warnings | M017 |
| UtaSpray | MENTHOL AND METHYL SALICYLATE | Big 5 Nutrition LLC | c641ab11-cd00-4e23-ace7-8178739084f0 | 2023-11-21 | Warnings | M017 |
| Top Medicated Oil | CAMPHOR, MENTHOL, METHYL SALICYLATE | Big 5 Nutrition LLC | b2f0d1e1-7d03-434e-be39-9f980459690c | 2023-11-21 | Warnings | M017 |
| BT Pain Relief Balm | METHYL SALICYLATE, MENTHOL, CAMPHOR | Big 5 Nutrition LLC | 50112419-c934-4d3a-9ea6-9b089f516a6d | 2023-11-21 | Warnings | M017 |
| BT Pain Relief | MENTHOL, METHYL SALICYLATE | Big 5 Nutrition LLC | 91324910-27cf-424f-9e9b-6173f2d7acbf | 2023-11-21 | Warnings | M017 |
| Dit Da Shui | MENTHOL AND METHYL SALICYLATE | Big 5 Nutrition LLC | 5d45cb48-3e88-4d58-81d2-6f88d7a82134 | 2023-11-20 | Warnings | M017 |
| Herbal Balm | METHYL SALICYLATE, MENTHOL AND | Big 5 Nutrition LLC | 09b3b86d-3434-428b-b0a8-e8dfd7c0b52a | 2023-11-20 | Warnings | M017 |
| Hydrocortisone | ANTIPRURITIC (ANTI-ITCH) | BluePoint Laboratories | b505769e-9c46-3cf3-e053-2a95a90a4df9 | 2023-11-17 | Warnings | M017 |
| Hydrocortisone | ANTIPRURITIC (ANTI-ITCH) | BluePoint Laboratories | d6523993-d781-cdbc-e053-2a95a90af191 | 2023-11-17 | Warnings | M017 |
| ZIMS MAX FREEZE PRO FORMULA | MENTHOL, UNSPECIFIED FORM | KOBAYASHI Healthcare International, Inc. | 4d91baf3-9655-4786-93b8-aa0d93fe0bf9 | 2023-11-16 | Warnings | M017 |
| ZIMS MAX FREEZE LEG CRAMP | MENTHOL | KOBAYASHI Healthcare International, Inc. | 7ef03298-6623-4cf4-b21f-74b2ffc11c6e | 2023-11-16 | Warnings | M017 |
| ZIMS MAX FREEZE PRO FORMULA | MENTHOL, UNSPECIFIED FORM | KOBAYASHI Healthcare International, Inc. | 436e8578-b609-4b45-8f84-0d111140fda6 | 2023-11-16 | Warnings | M017 |
| ZIMS MAX FREEZE PRO FORMULA | MENTHOL | KOBAYASHI Healthcare International, Inc. | 08dcfa78-7332-4f19-90d7-fdd7d446848a | 2023-11-16 | Warnings | M017 |
| Totally Fun After Sun | LIDOCAINE HCL | MJ Products Association, LLC | 965a2a29-914c-4ad0-b25f-5df3c30da393 | 2023-11-15 | Warnings | M017 |
| Universal Ice Cold Analgesic | MENTHOL | Universal Distribution Center LLC | 4fdf61d8-a9e0-4cd2-9e3f-0bdedc47a52f | 2023-11-15 | Warnings | M017 |
| ZIMS MAX FREEZE PRO FORMULA | MENTHOL, UNSPECIFIED FORM | KOBAYASHI Healthcare International, Inc. | b44beac3-1d20-434f-9a79-4fab1ac68791 | 2023-11-15 | Warnings | M017 |
| Universal Ice Cold Analgesic | MENTHOL | Universal Distribution Center LLC | 79ad55eb-b59d-4bb8-88e3-3b51e10a7f28 | 2023-11-15 | Warnings | M017 |
| PURE EASE Joint Muscle lnstant Pain Relief | CAPSAICIN, MENTHOL | SERENU, INC. | 42bf129c-5c84-4331-b6d0-78e3be71a985 | 2023-11-13 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 238542 | methyl salicylate 25 % Topical Cream | PSN | d8b8b0ba-69e9-4965-bf9b-6db21db69b34 | 1 |
| 238542 | methyl salicylate 250 MG/ML Topical Cream | SCD | d8b8b0ba-69e9-4965-bf9b-6db21db69b34 | 1 |
| 238542 | methyl salicylate 25 % Topical Cream | SY | d8b8b0ba-69e9-4965-bf9b-6db21db69b34 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50488-1016-5 | 50488101605 | 50 mL in 1 BOTTLE, PUMP (50488-1016-5) | 50 ml | 2024-05-01 | No | No | Current |