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 |
|---|---|---|---|---|---|---|
| TheraCare Lidocaine Pain Relief | LIDOCAINE | Veridian Healthcare | ee8cd550-64ee-432e-98e5-b68083179a3c | 2026-01-05 | Warnings | M017 |
| REGENECARE HA | LIDOCAINE HCL | MPM Medical LLC | 0eee554f-dfe0-433a-9665-8bdb95229888 | 2026-01-05 | Warnings | M017 |
| Pain Relieving Cream | CAMPHOR AND MENTHOL | PAIN WIZARD LIMITED LIABILITY COMPANY | 2647bba1-87f4-3c16-e063-6394a90ae0c9 | 2026-01-05 | Warnings | M017 |
| TheraCare Lidocaine plus Menthol | LIDOCAINE, MENTHOL | Veridian Healthcare | efddd116-d753-425a-9ded-09b8045024e4 | 2026-01-05 | Warnings | M017 |
| TheraCare Original Menthol | MENTHOL | Veridian Healthcare | ea56e4e1-a758-428b-8758-ee31bb00ca82 | 2026-01-05 | Warnings | M017 |
| Mugwort Patch (Cervical spine use) | 2%MENTHOL | YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED | 478e220c-0d35-9ee0-e063-6294a90ab689 | 2026-01-04 | Warnings | M017 |
| Mugwort Patch (Lumbar spine use) | 2%MENTHOL | YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED | 478e4b21-6d81-4cd3-e063-6394a90a18fe | 2026-01-04 | Warnings | M017 |
| Mugwort Patch (Knee use) | 2%MENTHOL | YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED | 478e86d2-3030-91eb-e063-6394a90a4db0 | 2026-01-04 | Warnings | M017 |
| American Safety and First Aid | HYDROCORTISONE ACETATE | Orazen Inc | 4a543f90-d43c-4487-b27e-f43394c6320d | 2026-01-04 | Warnings | M017 |
| Doctor Hoys Pain Relief Gel | MENTHOL, CAMPHOR (SYNTHETIC) | Dynamic Blending Specialists, Inc. | 50123bb9-d5d8-4ba6-ab94-8ed95fe0f5a8 | 2026-01-02 | Warnings | M017 |
| Doctor Hoys Pain Relief Gel Roll-On | MENTHOL, CAMPHOR (SYNTHETIC) | Dynamic Blending Specialists, Inc. | bf47acb2-6c90-4d5c-820b-447cac9305a4 | 2026-01-02 | Warnings | M017 |
| Amino Rip Muscle Pain Relief | LIDOCAINE HCL | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | 2bed5764-4217-4aa3-9d90-3b5460dcffa3 | 2026-01-02 | Warnings | M017 |
| Menthozen Cream | METHYL SALICYLATE, MENTHOL, CAPSAICIN | Village Pharma LLC | 63bb0283-cfbe-4e9c-8772-73062c0c8d05 | 2026-01-01 | Warnings | M017 |
| Menthozen Hydrogel | MENTHOL, CAPSAICIN | Village Pharma LLC | 4c979a71-7c8f-4dff-abae-bf4cdf8f67b4 | 2026-01-01 | Warnings | M017 |
| Lidozen Gel | LIDOCAINE HYDROCHLORIDE, MENTHOL | Village Pharma LLC | ffb7831f-4ca9-4d73-8303-e9cd90078982 | 2026-01-01 | Warnings | M017 |
| Sting Relief | BENZOCAINE, ISOPROPYL ALCOHOL | Yiwu Ori-Power Medtech Co.,Ltd. | 116ee6dc-9c49-2e11-e063-6394a90a44ed | 2026-01-01 | Warnings | M017 |
| Menthozen | METHYL SALICYLATE, MENTHOL, CAPSAICIN | Village Pharma LLC | 48b1b99e-d0ec-4e5c-b80c-c0d2d87ecb13 | 2026-01-01 | Warnings | M017 |
| NUVALU ICE THERAPY MENTHOL PAIN RELIEVING | MENTHOL | JC SALES | 5adf457e-b4d0-30c8-e063-6294a90a64b9 | 2026-01-01 | Warnings | M017 |
| NUVALU ICE THERAPY MENTHOL PAIN RELIEVING | MENTHOL | JC SALES | 490bc3b1-48bf-5437-e063-6394a90a9018 | 2026-01-01 | Warnings | M017 |
| NUVALU ICE THERAPY MENTHOL PAIN RELIEVING | MENTHOL | NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. | 5ae00308-0a8c-065c-e063-6394a90aff6b | 2026-01-01 | 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 |