Coolexa
- Product NDC
- 57237-351
- Requested package NDC
- 57237-351-13
- 11-digit product format
- 572370351
- Labeler code
- 57237
- Product ID
- 57237-351_9e551d98-76bc-4d63-9462-006e858528fb
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Camphor, Menthol, Methyl Salicylate
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-11-06
- Substance
- CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
- Active strength
- 40; 100; 300 mg/g; mg/g; 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
- Coolexa
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CAMPHOR (SYNTHETIC) | 40 mg/g |
| MENTHOL, UNSPECIFIED FORM | 100 mg/g |
| METHYL SALICYLATE | 300 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5TJD82A1ET | Internal UNII lookup |
| L7T10EIP3A | Internal UNII lookup |
| LAV5U5022Y | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 283083 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 38839f29-d4ce-4684-a3c7-0bb4bf1ad594 | 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 |
|---|---|---|---|---|---|---|
| 57237-351-13 | Coolexa | 1 in 1 CARTON | CREAM | 1 | 1 | |
| 57237-351-13 | Coolexa | 113 g in 1 TUBE | CREAM | 113 | 1 | |
| 57237-351-57 | Coolexa | 1 in 1 CARTON | CREAM | 1 | 1 | |
| 57237-351-57 | Coolexa | 57 g in 1 TUBE | CREAM | 57 | 1 |
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 |
|---|---|---|---|---|---|---|
| Hydrocortisone | HYDROCORTISONE 1% | Pharmacy Value Alliance LLC | ab95e606-69f0-1d58-e053-2a95a90a073b | 2024-12-20 | Warnings | M017 |
| Itch Relief Cream | ZINC ACETATE 0.1%, DIPHENHYDRAMINE HYDROCHLORIDE 2% | Pharmacy Value Alliance LLC | 37fe6d82-adee-4f58-e054-00144ff88e88 | 2024-12-20 | Warnings | M017 |
| Warrior First Aid Anti Itch | DIPHENHYDRAMINE HCL 2%, ZINC ACETATE 0.1% | Derma Care Research Labs, LLC | ec6e9a5b-c61d-a385-e053-2995a90ac936 | 2024-12-20 | Warnings | M017 |
| DCH Burn Relief | LIDOCAINE HCL | Derma Care Research Labs, LLC | ff227154-cf3b-9796-e053-6294a90a5535 | 2024-12-20 | Warnings | M017 |
| Outback Pain Relief | CAMPHOR 6%, MENTHOL 16% | Derma Care Research Labs, LLC | c238c930-2012-2d48-e053-2a95a90a8a4a | 2024-12-20 | Warnings | M017 |
| Meijer Pain Relief | LIDOCAINE HCL 4% | Meijer | f31b11ed-2ff9-5cfc-e053-2a95a90af2ca | 2024-12-20 | Warnings | M017 |
| Meijer Pain Relief | MENTHOL 10.5% | Meijer | bed81975-bd63-cf5b-e053-2995a90ac5fa | 2024-12-20 | Warnings | M017 |
| Mirakel Pain and Itch Relief | BENZOCAINE 20%, RESORCINOL 3% | Sanvio, Inc. | ed34d728-0275-e209-e053-2995a90a93ff | 2024-12-20 | Warnings | M017 |
| Meijer Pain Relief | LIDOCAINE 4% | Meijer | bed67c31-c479-6f9b-e053-2a95a90a5516 | 2024-12-20 | Warnings | M017 |
| Blue-Emu Ultra with Hemp Seed | TROLAMINE SALICYLATE | Kingsway Pharmaceuticals dba NFI, LLC | 80a3cf99-16e8-412b-ab9f-3d9d5cbb7aa9 | 2024-12-20 | Warnings | M017 |
| Epsom Salts | MAGNESIUM SULFATE | International Wholesale Inc. | e4d9bc32-ac85-349f-e053-2995a90a032f | 2024-12-19 | Warnings | M017 |
| Epsom Salts | MAGNESIUM SULFATE | International Wholesale Inc. | e5f3edc2-1b79-533a-e053-2a95a90ae9b6 | 2024-12-19 | Warnings | M017 |
| Leader | LIDOCAINE HCL | Cardinal Health | cea6bd2d-a265-1209-e053-2995a90ab0a5 | 2024-12-19 | Warnings | M017 |
| Rugby Anti-Itch | CAMPHOR, MENTHOL | RUGBY LABORATORIES | 99d8ad9e-46ec-15fc-e053-2995a90a0d17 | 2024-12-19 | Warnings | M017 |
| DCH Calaspray Itch Relief | PRAMOXINE HCL 1%, ZINC ACETATE 0.1% | Derma Care Research Labs, LLC | fda2afaf-3cd0-92b3-e053-6394a90a7493 | 2024-12-19 | Warnings | M017 |
| DCH Nerve Pain Relief Roll-On | LIDOCAINE HCL 4%, MENTHOL 1% | Derma Care Research Labs, LLC | ff32cbb2-79eb-9158-e053-6394a90ac357 | 2024-12-19 | Warnings | M017 |
| DCH Burn Relief | LIDOCAINE, 0.5% | Derma Care Research Labs | ffd7be08-0510-dfcb-e053-6394a90ad286 | 2024-12-19 | Warnings | M017 |
| DCH Arthritis Pain Relief Roll-On | CAPSAISIN 0.1% | Derma Care Research Labs, LLC | fda0d359-95eb-8b38-e053-6294a90a7b88 | 2024-12-19 | Warnings | M017 |
| DCH Pain Relieving | MENTHOL 2% | Derma Care Research Labs, LLC | ff49ee63-6a87-c7a7-e053-6294a90a77a3 | 2024-12-19 | Warnings | M017 |
| Warrior Pain Relief Roll-On Maximum Strength | LIDOCAINE HCL 4% | Derma Care Research Labs, LLC | dd80e560-6467-2166-e053-2995a90a88a8 | 2024-12-19 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 283083 | camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical Cream | PSN | 38839f29-d4ce-4684-a3c7-0bb4bf1ad594 | 1 |
| 283083 | camphor 40 MG/ML / menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical Cream | SCD | 38839f29-d4ce-4684-a3c7-0bb4bf1ad594 | 1 |
| 283083 | camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical Cream | SY | 38839f29-d4ce-4684-a3c7-0bb4bf1ad594 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 57237-351-13 | 57237035113 | 1 TUBE in 1 CARTON (57237-351-13) / 113 g in 1 TUBE | 1 tube | 2025-11-06 | No | No | Current |