PT Elite Premium Pain Relief
- Product NDC
- 85808-615
- 11-digit product format
- 858080615
- Labeler code
- 85808
- Product ID
- 85808-615_3a81868c-3aa7-5e51-e063-6294a90a2952
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- CAPSAICIN, MENTHOL
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- PT ELITE PRODUCTS LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-05-09
- Substance
- CAPSAICIN; MENTHOL
- Active strength
- .35; 40 mg/mL; mg/mL
- 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
- PT Elite Premium Pain Relief
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CAPSAICIN | .35 mg/mL |
| MENTHOL | 40 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| S07O44R1ZM | Internal UNII lookup |
| L7T10EIP3A | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1865193 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ad251821-4c58-425d-bdcb-8dd9bd41b713 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 473d070d-1c38-488e-b991-c4d1bf45aab8 | Product name | 1 | 20210201 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85808-615-00 | PT Elite Premium Pain Relief | 100 mL in 1 TUBE | CREAM | 100 | 2 | |
| 85808-615-00 | PT Elite Premium Pain Relief | 1 in 1 BOX | CREAM | 1 | 2 |
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 |
|---|---|---|---|---|---|---|
| OWELL NATURALS Deep Penetrating Pain Relief | MENTHOL | OWELL NATURALS BRAND, LLC | b36eb017-ed8d-476e-994b-22b275e00543 | 2024-01-02 | Warnings | M017 |
| Dibucaine | DIBUCAINE 1% | Trifecta Pharmaceuticals USA LLC | e8a56651-a292-7609-e053-2a95a90a7c36 | 2024-01-02 | Warnings | M017 |
| Anti-Itch Cream | DIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1% | Trifecta Pharmaceuticals USA, LLC. | 44d17651-a31b-64ca-e054-00144ff8d46c | 2024-01-02 | Warnings | M017 |
| Muscle Rub Cream | MENTHOL 10%, METHYL SALICYLATE 15% | Trifecta Pharmaceuticals USA, LLC. | e0a13344-5493-eb51-e053-2995a90a8183 | 2024-01-02 | Warnings | M017 |
| Sumifun Knee Relieve Patch | KNEE RELIEVE PATCH | Zhengzhou Miaoqi Pharmaceutical Technology Co., Ltd | 0e031aa5-edf4-8c9d-e063-6394a90afee3 | 2024-01-02 | Warnings | M017 |
| OKeeffes Healthy Feet | ALLANTOIN, LIDOCAINE | The Gorilla Glue Company/O'Keeffe's Company | d73709db-3932-3c56-e053-2995a90a7d0a | 2024-01-01 | Warnings | M017 |
| PERSONAL CARE ICE COLD | MENTHOL | NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. | 1994356c-e347-5b7d-e063-6394a90a476c | 2024-01-01 | Warnings | M017 |
| Dendracin Neurodendraxcin | METHYL SALICYLATE, MENTHOL AND CAPSAICIN | Proficient Rx LP | 7e765fc1-74c6-4af3-a9cf-05b57011d7d8 | 2024-01-01 | Warnings | M017 |
| CeraVe Developed with Dermatologists Itch Relief Moisturizing | PRAMOXINE HYDROCHLORIDE | L'Oreal USA Products Inc | c6a0880e-fc16-46e9-8314-c56c9d15bf31 | 2023-12-31 | Warnings | M017 |
| CeraVe Developed with Dermatologists Anti Itch | HYDROCORTISONE | L'Oreal USA Products Inc. | 8d65e945-2557-486f-9279-ecbaa08f31c4 | 2023-12-31 | Warnings | M017 |
| Nighttime Sleep-Aid Non-Habit Forming | DIPHENHYDRAMINE HCI | AptaPharma Inc. | ed0ba7aa-e794-43da-b576-6b9945bf7477 | 2023-12-30 | Warnings | M017 |
| Sting-Kill | BENZOCAINE AND MENTHOL | RANDOB LABS, LTD. DBA CROSSINGWELL CONSUMER HEALTH | b8bd9280-f20a-4b2a-aef7-a0ba7b3b8701 | 2023-12-29 | Warnings | M017 |
| Maybelline New York Baby Lips Dr Rescue Medicated Balm | MENTHOL | L'Oreal USA Products Inc | 2f7b8221-66f6-4aed-8359-318cfc656a72 | 2023-12-28 | Warnings | M017 |
| Equate Cortisone | HYDROCORTISONE 1% | Walmart Inc | 027fae33-93a0-a61f-e063-6294a90a990f | 2023-12-27 | Warnings | M017 |
| Walgreens Cool n Heat Lidocaine | LIDOCAINE HCL 4% | Walgreens Co | 0681c6c5-5a8b-ea9e-e063-6394a90a83bc | 2023-12-27 | Warnings | M017 |
| EXTRA STRENGTH WAL-DRYL ITCH RELIEF | DIPHENHYDRAMINE, ZINC ACETATE | WALGREEN CO | 681cf1af-2cc3-4e6d-b76f-f00731ea3e12 | 2023-12-27 | Warnings | M017 |
| XRay Pain Relief | MENTHOL, (PLUS)-, CAMPHOR, (-)-, AND METHYL SALICYLATE | Genomma Lab USA | 5244ddee-fd9e-4df3-8fb3-b16aa321a316 | 2023-12-27 | Warnings | M017 |
| Camphor Spirit | CAMPHOR 10% | Pharma Nobis, LLC | e42fbe63-b01c-4f85-e053-2a95a90a5143 | 2023-12-26 | Warnings | M017 |
| Equate Calaspray | PRAMOXINE HCL 1%, ZINC ACETATE 0.1% | Walmart Inc | 027ed5ab-05ec-569f-e063-6394a90abbc3 | 2023-12-26 | Warnings | M017 |
| EXTERNAL ANALGESIC | CAMPHOR, CAPSICUM, MENTHOL | Hmong 21 | 3b6155a5-51aa-2780-e054-00144ff8d46c | 2023-12-26 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1865193 | capsaicin 0.035 % / menthol 4 % Topical Cream | PSN | ad251821-4c58-425d-bdcb-8dd9bd41b713 | 2 |
| 1865193 | capsaicin 0.35 MG/ML / menthol 40 MG/ML Topical Cream | SCD | ad251821-4c58-425d-bdcb-8dd9bd41b713 | 2 |
| 1865193 | capsaicin 0.035 % / menthol 4 % Topical Cream | SY | ad251821-4c58-425d-bdcb-8dd9bd41b713 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85808-615-00 | 85808061500 | 1 TUBE in 1 BOX (85808-615-00) / 100 mL in 1 TUBE | 1 tube | 2025-05-09 | No | No | Current |