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 |
|---|---|---|---|---|---|---|
| Diphenhydramine HCl and Zinc Acetate | EXTRA STRENGTH ITCH RELIEF | VALU MERCHANDISERS, CO | 3e9c0f5b-cb76-475b-9a2b-39afa1eeb9ff | 2025-11-24 | Warnings | M017 |
| Menthol | MAXIMUM STRENGTH MEDICATED FOOT POWDER | VALU MERCHANDISERS, CO | 89a5c4bb-442f-d3f0-e053-2a95a90a51bd | 2025-11-24 | Warnings | M017 |
| Dragon Pain Relieving Balm | CAMPHOR, MENTHOL | AMERICANNA WELLNESS, INC. | 0d11ab8e-d3ea-c7ef-e063-6294a90ae0a3 | 2025-11-24 | Warnings | M017 |
| Dragon Pain Relieving | CAMPHOR, MENTHOL | AMERICANNA WELLNESS, INC. | 0d113dec-8832-d984-e063-6394a90ae7b3 | 2025-11-24 | Warnings | M017 |
| Dragon Pain Relieving Balm | CAMPHOR, MENTHOL | AMERICANNA WELLNESS, INC. | 0d12f03f-dd8b-0be5-e063-6294a90a43db | 2025-11-24 | Warnings | M017 |
| Thermacare Heat Therapy Max Strength Lidocaine Pain Relief Gel | THERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF GEL | Clarion Brands LLC | 445db02a-c8e8-6ebb-e063-6294a90a4301 | 2025-11-24 | Warnings | M017 |
| Dragon Pain Relieving Balm | CAMPHOR, MENTHOL | AMERICANNA WELLNESS, INC. | 0d129641-eaea-c3ee-e063-6394a90aa58f | 2025-11-24 | Warnings | M017 |
| Dragon Pain Relieving | CAMPHOR, MENTHOL | AMERICANNA WELLNESS, INC. | 0d1059cc-1b0b-4e7b-e063-6294a90a56ea | 2025-11-24 | Warnings | M017 |
| GuruNanda Pain Relief | MENTHOL AND CAMPHOR | GURUNANDA, LLC | 3ca78342-cc6d-5f6b-e063-6294a90a3f1c | 2025-11-24 | Warnings | M017 |
| Dragon Pain Relieving | CAMPHOR, MENTHOL | AMERICANNA WELLNESS, INC. | 0d118256-90ee-28ef-e063-6394a90a21e8 | 2025-11-24 | Warnings | M017 |
| health beyond | HYDROCORTISONE | Nantong Health & Beyond Hygienic Products Inc. | bdcd5b01-f5e2-4519-bf4d-25e3cc7e67af | 2025-11-23 | Warnings | M017 |
| NicDuic Quit Smoking Nicotine Patches 3 Step | NICOTINE PATCHES | Shenzhen Paxi Trading Co., Ltd. | 4429fea8-46f8-8f7f-e063-6394a90a34b4 | 2025-11-22 | Warnings | M017 |
| NicDuic Quit Smoking Nicotine Patches 2 Step | NICOTINE PATCHES | Shenzhen Paxi Trading Co., Ltd. | 442a926b-d7c1-4e35-e063-6394a90ad948 | 2025-11-22 | Warnings | M017 |
| NicDuic Quit Smoking Nicotine Patches 1 Step | NICOTINE PATCHES | Shenzhen Paxi Trading Co., Ltd. | 442aae32-4ac6-5dd6-e063-6294a90aad02 | 2025-11-22 | Warnings | M017 |
| NicDuic Quit Smoking Nicotine Patches 1-3 Step | 21MG NICOTINE PATCHES | Shenzhen Paxi Trading Co., Ltd. | 442ae0fa-a1ed-7901-e063-6294a90ab717 | 2025-11-22 | Warnings | M017 |
| IceQuake Lidocaine Analgesic | LIDOCAINE HYDROCHLORIDE | Dextrum Laboratories, Inc | 441daa6f-f273-ac09-e063-6394a90a252c | 2025-11-21 | Warnings | M017 |
| Nighttime 4X Medicated Cream | BENZOCAINE | Rite Aid | 21645ed1-2dc0-223a-e063-6394a90ab021 | 2025-11-21 | Warnings | M017 |
| 4x Medicated Gum Cream | BENZOCAINE | Albertsons | b81a308c-9c30-0e3d-e053-2a95a90a15d2 | 2025-11-21 | Warnings | M017 |
| MENTHOL, CAMPHOR | MENTHOL, CAMPHOR | SUNSET NOVELTIES, INC | b0edd9d9-951f-d3dd-e053-2995a90a8d5a | 2025-11-21 | Warnings | M017 |
| Up up | LIDOCAINE PAIN RELIEF MAXIMUM STRENGTH PATCHES | Target Corporation | 44121d40-86e1-0df6-e063-6294a90aedaf | 2025-11-20 | 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 |