Methyl Salicylate 25 Percent
- Product NDC
- 50488-1016
- Requested package NDC
- 50488-1016-5
- 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
- 2027-12-31
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 |
|---|---|---|---|---|---|---|
| Calypxo Pain Relief | METHYL SALICYLATE, MENTHOL | Advanced Rx of Tennessee, LLC | 0b7736df-c7e0-7d00-e063-6294a90aa57e | 2024-12-31 | Warnings | M017 |
| New Terocin | METHYL SALICYLATE, CAPSAICIN, AND MENTHOL | Advanced Rx Pharmacy of Tennessee, LLC | f4bfc4a6-06ef-1f76-e053-2995a90a2b8f | 2024-12-31 | Warnings | M017 |
| Lidocaine | LIDOCAINE | Advanced Rx Pharmacy of Tennessee, LLC | 01cb19a4-ce22-144d-e063-6294a90a8aa3 | 2024-12-31 | Warnings | M017 |
| Satohap Lidocaine 4% Menthol 1% Pain Relieving Cream | LIDOCAINE, MENTHOL | Sato Pharmaceutical Co., Ltd. | 2251e96b-d050-4ec2-a6b9-6659610885bf | 2024-12-30 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | Safeway | af2e2ef3-0f3f-4592-8081-b6553ade2f5a | 2024-12-26 | Warnings | M017 |
| Comforte Menstrual Cramp Relief Cream | MENTHOL | PMS4PMS LLC | c121537e-3333-4f35-8c77-20086158dff4 | 2024-12-26 | Warnings | M017 |
| N-Labs Arcticzen Pain Relief Knee | CAMPHOR (SYNTHETIC), MENTHOL | NUTRIOMO LABS PTE. LTD | 05ee574a-854c-4a77-be77-082055075c4d | 2024-12-26 | Warnings | M017 |
| BiteMD External Analgesic First Aid Antiseptic | BENZOCAINE, CAMPHOR (SYNTHETIC), AND PHENOL | United Industries Corporation | 4c60db03-6d2b-4ae0-a200-718b3a50eb0f | 2024-12-23 | Warnings | M017 |
| GNP Anti Itch | CAMPHOR, MENTHOL | AMERISOURCEBERGEN DRUG CORPORATION | b4f2d6f7-2287-47d8-e053-2995a90ae335 | 2024-12-23 | Warnings | M017 |
| cool and heat pain relieving liquid | MENTHOL | Bionpharma Inc. | ec6f59d8-45c5-46a0-e053-2995a90a239f | 2024-12-23 | Warnings | M017 |
| FOOT WORKS MAXIMUM CRACKED HEEL | BENZALKONIUM CHLORIDE, LIDOCAINE | COSMAX USA, CORPORATION | 29f92230-d1d4-5e94-e063-6294a90af812 | 2024-12-23 | Warnings | M017 |
| pain relief roll-on | LIDOCAINE 4% | Bionpharma Inc. | f607b6dc-8d13-604a-e053-2995a90a59ab | 2024-12-23 | Warnings | M017 |
| Veneno de Abeja Aceite De Vibora Brand | METHYL SALICYLATE | Miramar Cosmetics, Inc DBA Miramar Lab | a6c4889c-e7a9-44b9-bd9a-70fd6e8c4825 | 2024-12-23 | Warnings | M017 |
| Itch Relief | HYDROCORTISONE 1% | Trifecta Pharmaceuticals USA LLC | af5daf6c-bcad-8ebf-e053-2a95a90af1b0 | 2024-12-20 | Warnings | M017 |
| Pain Itch Relief | LIDOCAINE HCI | Trifecta Pharmaceutical USA LLC | f40b19a8-795c-f514-e053-2a95a90a6d15 | 2024-12-20 | Warnings | M017 |
| Muscle Rub Cream | MENTHOL 10%, METHYL SALICYLATE 15% | Trifecta Pharmaceuticals USA, LLC. | 44d3638d-f29b-0e01-e054-00144ff88e88 | 2024-12-20 | Warnings | M017 |
| Rhuli Gel | CAMPHOR, MENTHOL | Trifecta Pharmaceuticals USA, LLC. | 4fbb3c23-ed47-336e-e054-00144ff8d46c | 2024-12-20 | Warnings | M017 |
| Hydrocortisone Cream with Aloe | HYDROCORTISONE | Rugby Laboratories | 132982ea-cce6-687c-e063-6294a90a4632 | 2024-12-20 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE 1% | Pharmacy Value Alliance LLC | 9bb98452-a605-5c20-e053-2995a90a1ea7 | 2024-12-20 | Warnings | M017 |
| DCH Cooling Pain Relief | MENTHOL 10.5% | Derma Care Research Labs, LLC | 00dcdae0-c744-8402-e063-6294a90a12f8 | 2024-12-20 | 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 |