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 |
|---|---|---|---|---|---|---|
| SORE NO MORE COOL THERAPY | MENTHOL | SOMBRA COSMETICS INC. | 9aa1f0ac-3baf-4e45-9e3a-c28a99b22909 | 2025-05-12 | Warnings | M017 |
| Calm and Correct Serum with Lidocaine | LIDOCAINE 3 PERCENT | Renu Laboratories, LLC | ddcf1c2e-2f67-44d7-e053-2a95a90a812b | 2025-05-09 | Warnings | M017 |
| Mqupin Knee Patch | KNEE PATCH | Zhengzhou Miaoqi Pharmaceutical Technology Co., Ltd | 09772e4b-8193-3771-e063-6394a90a9516 | 2025-05-08 | Warnings | M017 |
| Hydrocortisone Cream | HYDROCORTISONE | Trifecta Pharmaceuticals USA | d57a59fb-c8f2-f73b-e053-2995a90a4cdb | 2025-05-08 | Warnings | M017 |
| Hydrocortisone Cream | HYDROCORTISONE | Trifecta Pharmaceuticals USA | 4c96ec41-841c-322b-e054-00144ff8d46c | 2025-05-08 | Warnings | M017 |
| GNP Extra Strength Anti-Itch Cream | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | Amerisource Bergen | 34a66224-ef3c-e36e-e063-6394a90ac99d | 2025-05-08 | Warnings | M017 |
| Good Neighbor Muscle Rub Cream | CAMPHOR 4.0%, MENTHOL 10.0%, METHYL SALICYLATE 30.0%, | Amerisource Bergen | 34924bb9-e3e8-70e6-e063-6294a90aaa8c | 2025-05-07 | Warnings | M017 |
| DermaRad Relief Post Radiation Calming | LIDOCAINE 3 PERCENT | Renu Laboratories, LLC | e5d64929-fb9c-7ebc-e053-2995a90a9318 | 2025-05-07 | Warnings | M017 |
| Cold Hot Medicated Patch 5% Menthol | MENTHOL | InterMed Laboratories Private Limited | 33ee0235-5a6e-0ea1-e063-6394a90a89a5 | 2025-05-06 | Warnings | M017 |
| DermaRad Relief | LIDOCAINE EMULSION | RENU LABORATORIES, LLC | d5e11f73-918b-eeac-e053-2995a90a4a83 | 2025-05-06 | Warnings | M017 |
| Plantar Fasciitis Pain Relief Gel-Patch | LIDOCAINE, MENTHOL | Guangzhou Zhupuyou E-commerce Co., Ltd | 34838622-b092-afeb-e063-6294a90ae7db | 2025-05-06 | Warnings | M017 |
| Climax Shield Delay | BENZOCAINE | PRODUCT MAX GROUP INC | 9c720cdc-f753-47ce-95ff-3b26e461a0ab | 2025-05-05 | Warnings | M017 |
| PediFix Lidocaine Pain-Relief Patches | LIDOCAINE PAIN-RELIEF PATCHES | PediFix, Inc | 346550b9-d2ba-184e-e063-6394a90a591a | 2025-05-05 | Warnings | M017 |
| Walgreens Stop Itch Gel | DIPHENHYDRAMINE HCL | Walgreens Co | 23586336-8f46-3dcd-e063-6394a90accc9 | 2025-05-04 | Warnings | M017 |
| WaxRx EarAcheRx Pain Relieving Drops | 4% LIDOCAINE HCL | DOCTOR EASY MEDICAL PRODUCTS, LLC | 34156655-8706-f0a4-e063-6294a90acc90 | 2025-05-01 | Warnings | M017 |
| foster and thrive anti itch cream | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | Strategic Sourcing Services LLC | bb08293d-5db8-4cc8-9fe3-bd02061dbeb9 | 2025-04-30 | Warnings | M017 |
| Maximum Strength 4% Lidocaine Patch | LIDOCAINE | Solis Pharmaceuticals Inc. | 3061d301-2104-b1b2-e063-6394a90a9b6e | 2025-04-29 | Warnings | M017 |
| Maximum Strength 4% Lidocaine Patch | LIDOCAINE | InterMed Laboratories Private Limited | 33ed754e-8852-d5b2-e063-6394a90a7cf2 | 2025-04-29 | Warnings | M017 |
| Cold Hot Medicated Patch 5% Menthol | MENTHOL | InterMed Laboratories Private Limited | 33ee6e48-243e-4ded-e063-6394a90a987d | 2025-04-29 | Warnings | M017 |
| Lidocaine Pain Relief Gel-Patch | LIDOCAINE | Guangzhou Zhupuyou E-commerce Co., Ltd | 32b96689-8e9b-4c2e-e063-6294a90a7d1c | 2025-04-29 | 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 |