METHYL SALICYLATE 25%
- Product NDC
- 85477-311
- 11-digit product format
- 854770311
- Labeler code
- 85477
- Product ID
- 85477-311_3c4bc55d-6581-3b5e-e063-6394a90a994c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- METHYL SALICYLATE
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Oncora Pharma, 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%
- 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 |
|---|---|
| 3c4bc55d-6582-3b5e-e063-6394a90a994c | 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 |
|---|---|---|---|---|---|---|
| 85477-311-10 | METHYL SALICYLATE 25% | 120 g in 1 TUBE | CREAM | 120 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 85477-311-10 | GM - Gram | 85477-311 | 3ba9d061-4b45-4a52-b329-ecfc311bb731 | 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 |
|---|---|---|---|---|---|---|
| Medicated Herbal Lip Balm | MENTHOL | Earth Mama Angel Baby LLC | 1cc2391e-6a7a-609c-e063-6394a90a6305 | 2024-10-01 | Warnings | M017 |
| CVS Health Lidocaine Plus Pain Relieving | LIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOL | NATURAL ESSENTIALS, INC. | 1adb9b74-4a01-4461-b845-f3aedcb3f810 | 2024-10-01 | Warnings | M017 |
| Circata | CAPSAICIN | PureTek Corporation | b67161d7-cc5c-e971-e053-2995a90acbe7 | 2024-10-01 | Warnings | M017 |
| Menticam | CAMPHOR,MENTHOL, METHYL SALICYLATE | PureTek Corporation | ffea2e97-777f-434b-e053-6394a90a3a63 | 2024-10-01 | Warnings | M017 |
| Herb Street Sore Muscle Relief | METHYL SALICYLATE | Balassa Laboratories Inc. | e43943c2-d4cd-44c5-a0ff-403a8d42860f | 2024-10-01 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | Kroger Company | 68dab606-0385-48b7-9a7b-a2cf83d20393 | 2024-09-29 | Warnings | M017 |
| kirkland signature hydrocortisone plus maximum strength | HYDROCORTISONE | Costco Wholesale Company | 481341c5-db1f-43fb-aed7-f40495a4eab8 | 2024-09-29 | Warnings | M017 |
| Care One hydrocortisone maximum strength | HYDROCORTISONE | American Sales Company | 32593229-d0ac-4d6c-831a-089fc6e76152 | 2024-09-29 | Warnings | M017 |
| good sense anti itch | HYDROCORTISONE | L. Perrigo Company | b7a896cc-1d78-45c0-a73e-aa1e117f7d3b | 2024-09-29 | Warnings | M017 |
| Topcare Hydrocortisone | HYDROCORTISONE | Topco Associates LLC | b7362f21-f1a3-4edc-b5b6-a16680e05df3 | 2024-09-29 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | H E B | 412ca2d1-064b-4438-aee1-fcb5cf27c7db | 2024-09-29 | Warnings | M017 |
| Topcare Antibiotic | NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE | Topco Associates LLC | 8c349cac-20e1-4600-9b0a-fcfe929551c5 | 2024-09-26 | Warnings | M017 |
| good sense anti itch | HYDROCORTISONE | A-S Medication Solutions | 072dd455-24a5-4a44-aaef-d3e137d005a6 | 2024-09-26 | Warnings | M017 |
| SYREN Intimate Relief | LIDOCAINE HYDROCHLORIDE | Icon Health Science | 57d5a080-3583-4510-e053-2a91aa0ad589 | 2024-09-25 | Warnings | M017 |
| AOSI HEALTHCARE | HYDROCORTISONE | Nantong Health & Beyond Hygienic Products Inc. | f4db90ad-dd62-44f1-9655-2614ed36581e | 2024-09-25 | Warnings | M017 |
| AOSI HEALTHCARE BURN | LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | a28b920c-0bb8-4b5a-addd-26ea164e036e | 2024-09-25 | Warnings | M017 |
| anti itch | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | Kroger Company | 067e718a-ec0b-4895-8f9f-82d64ab4c7b4 | 2024-09-24 | Warnings | M017 |
| topcare anti itch | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | Topco Associates LLC | e0fb332a-2903-41ef-b35b-7cd3a74cff99 | 2024-09-24 | Warnings | M017 |
| equaline anti itch | HYDROCORTISONE | United Natural Foods, Inc. dba UNFI | 83cd9f60-a4c4-4dea-97a7-cd96aade9e88 | 2024-09-24 | Warnings | M017 |
| good sense itch relief | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | L. Perrigo Company | 162fe0a3-3995-4e6f-94ed-f839b2b0c80e | 2024-09-24 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 238542 | methyl salicylate 25 % Topical Cream | PSN | 3c4bc55d-6582-3b5e-e063-6394a90a994c | 1 |
| 238542 | methyl salicylate 250 MG/ML Topical Cream | SCD | 3c4bc55d-6582-3b5e-e063-6394a90a994c | 1 |
| 238542 | methyl salicylate 25 % Topical Cream | SY | 3c4bc55d-6582-3b5e-e063-6394a90a994c | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85477-311-10 | 85477031110 | 120 g in 1 TUBE (85477-311-10) | 120 g | 2025-08-08 | No | No | Current |