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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
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 |