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 |
|---|---|---|---|---|---|---|
| Hempvana Cold As Ice Pain Relief | MENTHOL | Telebrands Corp | 95e84bb9-ba2e-5009-e053-2995a90a4362 | 2025-11-12 | Warnings | M017 |
| Lidozall | LIDOCAINE HYDROCHLORIDE | V2 Pharma LLC | 1eb2dfb2-3ad1-488b-aed9-17220e34a10c | 2025-11-12 | Warnings | M017 |
| Lidozall Plus | LIDOCAINE HYDROCHLORIDE | V2 Pharma LLC | ba3cbb15-f4ed-443e-af43-a758481acb0b | 2025-11-12 | Warnings | M017 |
| Knee Pain Relief Patch | DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE | Shenzhen Finona Information Technology Co., Ltd | 38755738-1a06-fdb4-e063-6294a90aa6eb | 2025-11-12 | Warnings | M017 |
| Recovery Numb | LIDOCAINE 4% | PURKLENZ FORMULATIONS INC. | e95e38e3-f743-4f5c-abdf-99ba6856e6f7 | 2025-11-12 | Warnings | M017 |
| Rapid Relief | COLD RELIEF PATCH 5% MENTHOL | RAPID AID VIET NAM COMPANY LIMITED | 434c13c2-52ee-000f-e063-6294a90af7e7 | 2025-11-11 | Warnings | M017 |
| Rapid Relief | PAIN RELIEF PATCH CAMPHOR 110MG MENTHOL 33MG CAPSICUM EXTRACT 22MG | RAPID AID VIET NAM COMPANY LIMITED | 434d5f92-05c2-d884-e063-6394a90ad28c | 2025-11-11 | Warnings | M017 |
| Rapid Relief | PAIN RELIEF PATCH LIDOCAINE 4% MENTHOL 1% | RAPID AID VIET NAM COMPANY LIMITED | 434df0be-49ff-aa56-e063-6394a90a3b5a | 2025-11-11 | Warnings | M017 |
| TopCare Pain Relief Maximum Strength | LIDOCAINE HYDROCHLORIDE | TOPCO ASSOCIATES | b0ae3a7c-52d1-4923-bd50-6bb3749006c8 | 2025-11-11 | Warnings | M017 |
| Comfortcaine | LIDOCAINE HCL | QS Key West Aloe, LLC | 831b7c11-e437-4e74-808e-c9c1eb8b82f6 | 2025-11-11 | Warnings | M017 |
| A and E Marathon Delay Serum | DELAY SERUM | Phe Inc | 4355d1d8-44fe-aca1-e063-6294a90a85ff | 2025-11-11 | Warnings | M017 |
| A and E Deep Throat Desensitizing SprayStrawberry | ORAL NUMBING SPRAY STRAWBERRY | Phe Inc | 4355dab1-a293-ded6-e063-6394a90af9b0 | 2025-11-11 | Warnings | M017 |
| A and E Easy Anal Gel | ANAL NUMBING LUBRICANT | Phe Inc | 4355e0f3-65ba-eca6-e063-6394a90ab43c | 2025-11-11 | Warnings | M017 |
| A and E Deep Throat Desensitizing SprayPeppermint | ORAL NUMBING SPRAY MINT | Phe Inc | 4355e0d0-1222-d594-e063-6294a90abb29 | 2025-11-11 | Warnings | M017 |
| DermaNumb Analgesic | LIDOCAINE HCL | A.T.S. Laboratories, LLC | 0ea46890-45c3-4732-bc47-227f7c67daf1 | 2025-11-11 | Warnings | M017 |
| Derma Numb Pain Relief | LIDOCAINE HCL | A.T.S. Laboratories, LLC | 710991ae-8f82-4893-93a7-0ef3f815d132 | 2025-11-11 | Warnings | M017 |
| HYDROCORTISONE | HYDROCORTISONE | Encube Ethicals, Inc. | 969cd576-82d3-4662-bbc1-3587a1f6a564 | 2025-11-10 | Warnings | M017 |
| Jelcaine Sterile | LIDOCAINE HCL JELLY USP, 2% | Brookfield Pharmaceuticals, LLC | 1a39d1de-7aa2-3068-e063-6394a90aed85 | 2025-11-10 | Warnings | M017 |
| Hush Anesthetic | LIDOCAINE | HUSH Anesthetic | c6e86a0f-6f9b-45b7-86ce-0bb1c198061a | 2025-11-10 | Warnings | M017 |
| Hush Anesthetic | LIDOCAINE | HUSH Anesthetic | 97ae1993-7268-4b7f-92e2-6004337d5650 | 2025-11-10 | 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 |