PERFORM COOL and SOOTHING PAIN RELIEVING
- Product NDC
- 59316-111
- 11-digit product format
- 593160111
- Labeler code
- 59316
- Product ID
- 59316-111_51e0a9b2-bf58-7444-e063-6394a90a3e3a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- MENTHOL
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Reckitt Benckiser LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-05-18
- Substance
- MENTHOL, UNSPECIFIED FORM
- Active strength
- 35 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 59316-111 | 59316-111-10 | D | Discontinued by firm | 2026-10-23 | |
| excluded package | package | 59316-111 | 59316-111-11 | D | Discontinued by firm | 2026-10-23 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 59316-111-11 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 59316-111-10 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 59316-111-11 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 59316-111-10 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 59316-111-11 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 59316-111-10 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 59316-111-11 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 59316-111-10 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 59316-111-11 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 59316-111-10 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 59316-111-11 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 59316-111-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 59316-111-11 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 59316-111-10 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 59316-111-11 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 59316-111-10 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 59316-111-11 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 59316-111-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 59316-111-11 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 59316-111-10 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 59316-111-11 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 59316-111-10 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 59316-111-11 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 59316-111-10 | 557ba5c1ecfa… | 9c80585c8c6e… |
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
- PERFORM COOL and SOOTHING PAIN RELIEVING
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL, UNSPECIFIED FORM | 35 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 808955 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ef158f63-2d75-47a3-b94a-2d821d511863 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59316-111-10 | PERFORM COOL and SOOTHING PAIN RELIEVING | 3 mL in 1 TUBE | GEL | 3 | 9 | |
| 59316-111-11 | PERFORM COOL and SOOTHING PAIN RELIEVING | 30 mL in 1 BOTTLE | GEL | 30 | 9 | |
| 59316-111-20 | PERFORM COOL and SOOTHING PAIN RELIEVING | 1 in 1 CARTON | GEL | 1 | 9 | |
| 59316-111-20 | PERFORM COOL and SOOTHING PAIN RELIEVING | 118 mL in 1 TUBE | GEL | 118 | 9 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| Good Neighbor Roll-on Menthol Pain Relief Gel | MENTHOL | Amerisource Bergen | bd557323-0003-4ee6-b22d-a72d621c7de4 | 2025-08-05 | Warnings | M017 |
| Earthmed FS Pain relieving balm | MENTHOL | Earthmed LLC | 3ba4e769-fec6-52d9-e063-6394a90a65d4 | 2025-08-05 | Warnings | M017 |
| HYDROCORTISONE | HYDROCORTISONE | HF Acquisition Co LLC, DBA HealthFirst | 3ba6a5ec-fda2-b2a6-e063-6294a90ac9b6 | 2025-08-05 | Warnings | M017 |
| Kocowo Lidocaine Pain Relief Gel-Patch | LIDOCAINE PAIN RELIEF GEL-PATCH | Henan Enokon Medical Instrument Co., Ltd. | 3b82989d-7cc3-23d3-e063-6294a90ae2a3 | 2025-08-03 | Warnings | M017 |
| Menthol pain relief patches | MENTHOL | Menthol pain relief patch | 3b5fd718-3f86-f7a7-e063-6294a90a8c52 | 2025-08-02 | Warnings | M017 |
| Graphene Far Infrared Herbal Pain Relief Patches | CORYDALIS RHIZOME | Changsha Maocheng Trading Co., Ltd | 3b604a3c-fe91-7096-e063-6394a90afe04 | 2025-08-02 | Warnings | M017 |
| Active Recovery Pain Relief | CAMPHOR, MENTHOL | Charlotte's Web, Inc. | 3a9f9ca0-3d8a-796a-e063-6394a90a790c | 2025-08-01 | Warnings | M017 |
| Active Recovery Pain Relief Stick | CAMPHOR, MENTHOL | Charlottes Web, Inc. | 3aa037c6-6109-b52e-e063-6394a90a215b | 2025-08-01 | Warnings | M017 |
| PM Recovery Pain Relief | CAMPHOR, MENTHOL | Charlotte's Web, Inc. | 3aa08859-809d-de8c-e063-6394a90a8e25 | 2025-08-01 | Warnings | M017 |
| Wish ultra winter ice | MENTHOL | LJ Pharma | b4c5487c-1314-4d63-96df-077e72e7ee95 | 2025-08-01 | Warnings | M017 |
| Rugged Fit Pain Relief Roll On | MENTHOL, METHYL SALICYLATE | SYSTEM4BOOK LLC | 39d68734-981c-14d7-e063-6294a90a4919 | 2025-08-01 | Warnings | M017 |
| ICY FREEZE | MENTHOL, UNSPECIFIED FORM | Natural Essentials, Inc. | 28fdb049-b297-4358-9447-7d69ba879702 | 2025-08-01 | Warnings | M017 |
| Cortizone 10 Cooling | HYDROCORTISONE | Chattem, Inc. | 14d9fce2-9f54-4204-83cb-161de8a303f0 | 2025-08-01 | Warnings | M017 |
| Bravado Labs Numbing | LIDOCAINE HCL | Prodigy Media Inc | 8c43f5b5-b911-4a7a-b2d1-56a09c54b001 | 2025-07-30 | Warnings | M017 |
| Chimera GUARD | LIDOCAINE PAIN RELIEFING PATCH | Hangzhou Rongna Health Technology Co., Ltd. | 3721c984-1993-6265-e063-6394a90af23f | 2025-07-29 | Warnings | M017 |
| Chimera GUARD | LIDOCAINE PAIN RELIEFING PATCH | Hangzhou Rongna Health Technology Co., Ltd. | 3758d625-010f-7441-e063-6394a90a066d | 2025-07-29 | Warnings | M017 |
| Cold Therapy Roll on | COLD THERAPY ROLL ON | Allegiant Health | 36463acb-7c28-416f-a45f-a93f0be5692b | 2025-07-29 | Warnings | M017 |
| ProCure Anti Itch | CAMPHOR 0.5% | Twin Med LLC | 3afe387c-ef42-215d-e063-6394a90a41b5 | 2025-07-28 | Warnings | M017 |
| lidocaine pain relief patches | LIDOCAINE | Changsha Maocheng Trading Co., Ltd | 3afeead3-4f5c-4711-e063-6294a90aacca | 2025-07-28 | Warnings | M017 |
| SYNC ICE | SYNC RELIEF ICE | iON Pharma, LLC | 38ce98ce-a7bf-8041-e063-6394a90ae730 | 2025-07-28 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 808955 | menthol 3.5 % Topical Gel | PSN | ef158f63-2d75-47a3-b94a-2d821d511863 | 9 |
| 808955 | menthol 0.035 MG/MG Topical Gel | SCD | ef158f63-2d75-47a3-b94a-2d821d511863 | 9 |
| 808955 | menthol 3.5 % Topical Gel | SY | ef158f63-2d75-47a3-b94a-2d821d511863 | 9 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 59316-111-10 | 59316011110 | 3 mL in 1 TUBE (59316-111-10) | 3 ml | 2015-05-18 | 2023-12-31 | No | No | Current |
| 59316-111-11 | 59316011111 | 30 mL in 1 BOTTLE (59316-111-11) | 30 ml | 2015-05-18 | 2023-12-31 | No | No | Current |
| 59316-111-20 | 59316011120 | 1 TUBE in 1 CARTON (59316-111-20) / 118 mL in 1 TUBE | 1 tube | 2015-05-18 | 0000-00-00 | No | No | Current |