PURE EASE Joint Muscle lnstant Pain Relief
- Product NDC
- 83676-435
- 11-digit product format
- 836760435
- Labeler code
- 83676
- Product ID
- 83676-435_0a063d7f-23a2-c949-e063-6294a90a5b57
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- CAPSAICIN, MENTHOL
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- SERENU, INC.
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-11-27
- Substance
- CAPSAICIN; MENTHOL
- Active strength
- .25; 80 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
- PURE EASE Joint Muscle lnstant Pain Relief
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CAPSAICIN | .25 mg/mL |
| MENTHOL | 80 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| S07O44R1ZM | Internal UNII lookup |
| L7T10EIP3A | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 42bf129c-5c84-4331-b6d0-78e3be71a985 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b82b4008-22fd-05f5-6cc6-c0a6e81c65b8 | Product name | 2 | 20240805 |
| 473d070d-1c38-488e-b991-c4d1bf45aab8 | Product name | 1 | 20210201 |
| d206bb34-ea65-399d-70d9-834f22dc2c18 | Product name | 3 | 20170724 |
| 1681bc73-b05f-12c3-1075-382ae39f449c | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83676-435-00 | PURE EASE Joint Muscle lnstant Pain Relief | 60 mL in 1 JAR | CREAM | 60 | 1 |
DailyMed Dashboard NDC Coverage#
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 | ANTIPRURITIC (ANTI-ITCH) | BluePoint Laboratories | b505769e-9c46-3cf3-e053-2a95a90a4df9 | 2023-11-17 | Warnings | M017 |
| Hydrocortisone | ANTIPRURITIC (ANTI-ITCH) | BluePoint Laboratories | d6523993-d781-cdbc-e053-2a95a90af191 | 2023-11-17 | Warnings | M017 |
| ZIMS MAX FREEZE PRO FORMULA | MENTHOL, UNSPECIFIED FORM | KOBAYASHI Healthcare International, Inc. | 4d91baf3-9655-4786-93b8-aa0d93fe0bf9 | 2023-11-16 | Warnings | M017 |
| ZIMS MAX FREEZE LEG CRAMP | MENTHOL | KOBAYASHI Healthcare International, Inc. | 7ef03298-6623-4cf4-b21f-74b2ffc11c6e | 2023-11-16 | Warnings | M017 |
| ZIMS MAX FREEZE PRO FORMULA | MENTHOL, UNSPECIFIED FORM | KOBAYASHI Healthcare International, Inc. | 436e8578-b609-4b45-8f84-0d111140fda6 | 2023-11-16 | Warnings | M017 |
| ZIMS MAX FREEZE PRO FORMULA | MENTHOL | KOBAYASHI Healthcare International, Inc. | 08dcfa78-7332-4f19-90d7-fdd7d446848a | 2023-11-16 | Warnings | M017 |
| Totally Fun After Sun | LIDOCAINE HCL | MJ Products Association, LLC | 965a2a29-914c-4ad0-b25f-5df3c30da393 | 2023-11-15 | Warnings | M017 |
| Universal Ice Cold Analgesic | MENTHOL | Universal Distribution Center LLC | 4fdf61d8-a9e0-4cd2-9e3f-0bdedc47a52f | 2023-11-15 | Warnings | M017 |
| ZIMS MAX FREEZE PRO FORMULA | MENTHOL, UNSPECIFIED FORM | KOBAYASHI Healthcare International, Inc. | b44beac3-1d20-434f-9a79-4fab1ac68791 | 2023-11-15 | Warnings | M017 |
| Universal Ice Cold Analgesic | MENTHOL | Universal Distribution Center LLC | 79ad55eb-b59d-4bb8-88e3-3b51e10a7f28 | 2023-11-15 | Warnings | M017 |
| PURE EASE Joint Muscle lnstant Pain Relief | CAPSAICIN, MENTHOL | SERENU, INC. | 42bf129c-5c84-4331-b6d0-78e3be71a985 | 2023-11-13 | Warnings | M017 83676-435 |
| PURE EASE Neur Cream Instant Deep Pain Relief | CAPSAICIN, MENTHOL | SERENU, INC. | e46a4636-6405-440a-a05a-862c354bab54 | 2023-11-13 | Warnings | M017 |
| Cryomax Cooling | MENTHOL | LIFE WEAR TECHNOLOGIES | 0a0ae5ba-9fac-45f6-e063-6294a90ad555 | 2023-11-13 | Warnings | M017 |
| LBri Super Aloe Stop The Pain | METHYL SALICYLATE, MENTHOL, CAPSAICIN | L'Bris, Pure 'N Natural | 8fb2010c-c34b-4552-858d-a0188ad313ad | 2023-11-11 | Warnings | M017 |
| TOTAL RELIEF | HYDROCORTISONE | DR. MARDER SKINCARE, LLC | 2c05459c-5a2c-45ab-b534-87f966b41681 | 2023-11-11 | Warnings | M017 |
| Human Science Muscle Pain Relief | METHYL SALICYLATE, MENTHOL | Human Science, LLC | 4bccc017-264b-11ce-e054-00144ff8d46c | 2023-11-11 | Warnings | M017 |
| Lidozen | LIDOCAINE HYDROCHLORIDE, MENTHOL | Village Pharma, LLC | 55108ffd-d6a8-41de-e054-00144ff88e88 | 2023-11-11 | Warnings | M017 |
| Debbies Down and Dirty Deep Tissue Joint and Muscle | MENTHOL | DD&D Manufacturing Co., Ltd | 531fe834-53e3-305f-e054-00144ff88e88 | 2023-11-11 | Warnings | M017 |
| TerraFreeze Pain Relief | MENTHOL,METHYL SALICYLATE,HISTAMINE DIHYDROCHLORIDE | Beyond Derma, LLC | 81dc70b3-7e93-4f9a-ae3a-b50bbfd1a677 | 2023-11-11 | Warnings | M017 |
| GOLD ICE Pain Relief | MENTHOL | Eden's Answers, Inc. | a1356c39-42b9-4bd8-a873-bcd40717058b | 2023-11-11 | Warnings | M017 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 83676-435-00 | 83676043500 | 60 mL in 1 JAR (83676-435-00) | 60 ml | 2023-11-27 | No | No | Current |