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 | 2026-10-27 | |
| excluded package | package | 59316-111 | 59316-111-11 | D | Discontinued by firm | 2026-10-27 |
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 |
|---|---|---|---|---|---|---|
| PLANTAR FASCIITIS Relief Gel Roll-On | MENTHOL | Guangzhou Zhupuyou E-commerce Co., Ltd | 37570149-dae1-a4f2-e063-6294a90a3245 | 2025-06-11 | Warnings | M017 |
| Diabecin CS Cream | MENTHOL, CAPSAICIN | Puretek Corporation | 33ef2233-7a66-ee65-e063-6294a90ac55a | 2025-06-10 | Warnings | M017 |
| KINKAN COOL | DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL | KINKANDO CO., LTD . | 82011efe-825c-4102-b6f1-59eff4c8040a | 2025-06-10 | Warnings | M017 |
| MQUPIN Knee Patch | KNEE PATCH | Zhengzhou Miaoqi Medical Technology Co., Ltd. | 37438a70-dab7-ecb5-e063-6394a90afefb | 2025-06-10 | Warnings | M017 |
| ORTHOGEL Menthol 3.5% Roll On | MENTHOL | LiquidCapsule Manufacturing LLC | 99424327-67e9-43b5-a117-94c9643413c1 | 2025-06-07 | Warnings | M017 |
| Lightning Pain Relief | MENTHOL | Ebanel Laboratories, Inc | 36edbc3f-501c-c1ea-e063-6394a90af6af | 2025-06-06 | Warnings | M017 |
| FREEZE IT Menthol Roll On | MENTHOL | LiquidCapsule Manufacturing LLC | 33094afe-db9d-4b92-8047-6dd611484fc9 | 2025-06-05 | Warnings | M017 |
| Band Aid Antiseptic Cleansing | BENZALKONIUM CHLORIDE, PRAMOXINE HCL | Kenvue Brands LLC | d55e6b09-0587-61a9-e053-2995a90afaf5 | 2025-06-05 | Warnings | M017 |
| FREEZE IT Menthol | MENTHOL | LiquidCapsule Manufacturing LLC | de8d8007-5718-4fb4-a8c6-4650d2ca9c8f | 2025-06-05 | Warnings | M017 |
| HEEL PAIN Relief Gel Roll-On | MENTHOL | Guangzhou Zhupuyou E-commerce Co., Ltd | 36bacb5f-c1af-2e97-e063-6394a90afe5c | 2025-06-04 | Warnings | M017 |
| Capsaicin 0.075% Cream | CAPSAICIN | ViolaCare, Inc. | 30911225-a6d7-4b2b-9005-b733373e2877 | 2025-06-04 | Warnings | M017 |
| LidoGuard | LIDOCAINE HCL | ViolaCare, Inc. | 531383aa-4f0f-4fe0-91f4-d809b39f160f | 2025-06-04 | Warnings | M017 |
| HealthWise Lidocaine and Menthol | LIDOCAINE AND MENTHOL | Veridian Healthcare | 36c27642-f913-1aad-e063-6294a90a4343 | 2025-06-04 | Warnings | M017 |
| HealthWise Ultra OTC Strength Pain Relief Cream | CAMPHOR, MENTHOL, AND METHYL SALICYLATE | Veridian Healthcare | 36c3bbf9-a559-4c0d-e063-6394a90a8a1a | 2025-06-04 | Warnings | M017 |
| Everlight Survival Sting Relief Pad | BENZOCAINE | Yiwu Ori-Power Medtech Co.,Ltd. | 364c9882-339e-fe22-e063-6294a90a37f4 | 2025-06-04 | Warnings | M017 |
| LIGHTS Sting Relief Prep Pad | BENZOCAINE | Lights Medical Manufacture Co., Ltd. | 4f4d7758-be62-4304-8871-087a90497fa5 | 2025-06-04 | Warnings | M017 |
| Elsophie Nicotine Patches Quit | NICOTINE PATCHES QUIT SMOKING | Shenzhen Xinxin Yunhai Technology Co., Ltd. | 36b63da9-94cc-b52a-e063-6394a90a5029 | 2025-06-03 | Warnings | M017 |
| Burn | LIDOCAINE HYDROCHLORIDE | J&A Digital Inc. | d4b09055-b93e-466f-9e24-cae098af6e24 | 2025-06-02 | Warnings | M017 |
| RE-LEVE | MENTHOL | SOMBRA COSMETICS INC. | b4b39d79-0439-41e7-adca-e5ccb8f44e40 | 2025-05-29 | Warnings | M017 |
| PAIN NO MORE THERAPY | MENTHOL CAMPHOR | SOMBRA COSMETICS INC. | f7bacc8e-6a8b-4cd8-bd0e-68890bee5818 | 2025-05-29 | 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 |