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 | 2026-10-21 | |
| excluded package | package | 59316-111 | 59316-111-11 | D | Discontinued by firm | 2026-10-21 |
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 |
|---|---|---|---|---|---|---|
| MENTHOL, CAMPHOR | MENTHOL, CAMPHOR | SUNSET PAIN RELIEF | 4a7f92d3-dd35-44a3-e063-6294a90ae004 | 2026-02-10 | Warnings | M017 |
| NICOVITO HEMORRHOID MASTER | LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID MASTER | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a5e24fa-959e-79b4-e063-6294a90a8f68 | 2026-02-09 | Warnings | M017 |
| Tiger Balm Active Muscle Rub | METHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC) | Haw Par Healthcare Ltd. | 2e7638c6-e1ce-4e2f-bd50-52fbce5a138e | 2026-02-09 | Warnings | M017 |
| Tiger Balm Neck and Shoulder Rub | CAMPHOR (SYNTHETIC) AND MENTHOL | Haw Par Healthcare Ltd. | 2f272d12-7b34-430e-817e-1005f57ed9e9 | 2026-02-09 | Warnings | M017 |
| Welmate Lidocaine Pain Relieving Patch | LIDOCAINE | YYBA CORP | 4303fd30-0d35-3671-e063-6394a90a2aee | 2026-02-09 | Warnings | M017 |
| Pain Relief Lidocaine | LIDOCAINE | Kroger Company | 4098756e-3d9f-317a-e063-6394a90af04c | 2026-02-09 | Warnings | M017 |
| Aquanil HC | HYDROCORTISONE | Person and Covey | 4a698246-05a6-d01f-e063-6294a90a3401 | 2026-02-09 | Warnings | M017 |
| Hemorrhoid Master | LIDOCAINE, PHENYLEPHRINE | Ebanel Laboratories, Inc | 41292d65-dabe-4bc3-872f-34a3912aa342 | 2026-02-09 | Warnings | M017 |
| DERMFREE NEUROPATHY | ARNICA MONTANA 1X HPUS 7% NEUROPATHY | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a5c232d-5d29-2504-e063-6394a90ac9de | 2026-02-08 | Warnings | M017 |
| ASSIELF NUMBING Topical Anorectal | LIDOCAINE | Shenzhen Yuanbang International Logistics Co., Ltd | 4a5cb477-57ef-2a1d-e063-6394a90ac9ed | 2026-02-08 | Warnings | M017 |
| Lidocaine Pain Relieve Gel-Patch | PAIN RELIEVE GEL-PATCH | Henan Kangdi Medical Devices Co., Ltd | 1e31b950-e990-e255-e063-6394a90a7d23 | 2026-02-07 | Warnings | M017 |
| Herbal Knee Patch | HERBAL KNEE PATCH | Henan Kangdi Medical Devices Co., Ltd | 2a009059-b515-8214-e063-6294a90a4ed3 | 2026-02-07 | Warnings | M017 |
| Flocean ANTI-ITCH | BENZOCAINE 5%ANTI-ITCH | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a493911-a846-5aa0-e063-6294a90a65ac | 2026-02-07 | Warnings | M017 |
| daily solutions Ice Blue Analgesic | MENTHOL, UNSPECIFIED FORM | Garcoa, Inc. | 4d8c8c14-ecaa-43de-a07f-c73ca0d1e3e6 | 2026-02-06 | Warnings | M017 |
| Lidocaine Pain Relief Gel-Patch | LIDOCAINE | Shenzhen Wankelai E-commerce Co., Ltd. | 4a22562b-601e-97d7-e063-6394a90a5bca | 2026-02-06 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | Sportpharm LLC | ee64ad1e-78db-4553-a3cf-b539b770fa26 | 2026-02-06 | Warnings | M017 |
| Pain Relief Gel-Patch | LIDOCAINE 4% | Sportpharm LLC | 1dd022b9-88ae-4737-88cc-fdb0ce0a83a3 | 2026-02-06 | Warnings | M017 |
| Camphor plus Lidocaine Pain Relief | CAMPHOR, LIDOCAINE | Veridian Healthcare | 4a2b73a8-c10c-85f9-e063-6294a90ac52c | 2026-02-06 | Warnings | M017 |
| Aloe Vera Gel | LIDOCAINE HCL, MENTHOL | Retail Business Services, LLC | 073c72fe-3171-4a4f-913a-d1b9630a1af3 | 2026-02-06 | Warnings, Adverse reactions | M017 |
| HealthWise Soothing Lidocaine Pain Relief | LIDOCAINE HCI 0.5% | Veridian Healthcare | 4a2ec73e-7332-6f13-e063-6294a90a8506 | 2026-02-06 | 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 |