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 |
|---|---|---|---|---|---|---|
| Painless Tattoo 1 | BENZOCAINE | Sambria Pharmaceuticals, LLC | 2f8fdcac-b87a-4191-9504-480a473f95cc | 2025-11-12 | Warnings | M017 |
| Painless Tattoo 2 | LIDOCAINE | Sambria Pharmaceuticals, LLC | 180b2899-7699-40e2-974a-081a6ce2bca2 | 2025-11-12 | Warnings | M017 |
| Painless Tattoo 3 | TETRACAINE | Sambria Pharmaceuticals, LLC | 9c24dcff-3988-40eb-821a-fd4b0c85f528 | 2025-11-12 | Warnings | M017 |
| Tattoo Numbing Cream Co | LIDOCAINE HYDROCHLORIDE | Sambria Pharmaceuticals, LLC | 2a64b3ef-ed2d-49db-996d-f63ffecb5a1e | 2025-11-12 | Warnings | M017 |
| Painless Tattoo Numbing | LIDOCAINE HYDROCHLORIDE | Sambria Pharmaceuticals, LLC | efd3289f-dfb2-487c-a76f-00fe8af414e3 | 2025-11-12 | Warnings | M017 |
| Now Numb Numbing Cream | LIDOCAINE HYDROCHLORIDE | Sambria Pharmaceuticals, LLC | fed833f5-4f76-46e8-8ae1-655a9e576f70 | 2025-11-12 | Warnings | M017 |
| Painless Tattoo Numbing Cream | LIDOCAINE HYDROCHLORIDE | Sambria Pharmaceuticals, LLC | 852504ec-d4fa-4cae-ba89-7ffb57df8efe | 2025-11-12 | Warnings | M017 |
| Arte Maximum strength Numbing Cream | LIDOCAINE HYDROCHLORIDE | Sambria Pharmaceuticals, LLC | e612a256-3f44-46db-bb6a-e550c2216fdc | 2025-11-12 | Warnings | M017 |
| Hello Sugar | LIDOCAINE HYDROCHLORIDE | Sambria Pharmaceuticals, LLC | 5f30254d-a28f-443d-8729-5c5dde4a0217 | 2025-11-12 | Warnings | M017 |
| YULAM DIE DA WAN HUA PAIN RELIEVING | MENTHOL AND CAMPHOR | MADISON ONE ACME INC | 1ba3c31b-2737-4b55-a0ea-90013a1d8cf4 | 2025-11-12 | Warnings, Adverse reactions | M017 |
| TattooNumb | LIDOCAINE HYDROCHLORIDE | Sambria Pharmaceuticals, LLC | d9c4d664-54de-40c2-8836-72b60e6d9ac0 | 2025-11-12 | Warnings | M017 |
| BeardedMoney | LIDOCAINE HYDROCHLORIDE | Sambria Pharmaceuticals, LLC | 35ff688b-75c5-4780-b294-192af780d705 | 2025-11-12 | Warnings | M017 |
| NeuroMed 7 Topical Pain Relief | LIDOCAINE HYDROCHLORIDE | Sambria Pharmaceuticals, LLC | f199f56b-d971-4cf8-834d-babb5c2ff81a | 2025-11-12 | Warnings | M017 |
| NeuroMed Topical Anesthetic 7 | LIDOCAINE HYDROCHLORIDE | Sambria Pharmaceuticals | 8a2b6b76-6bcc-4f52-b037-e6cbc74f8377 | 2025-11-12 | Warnings | M017 |
| NeuroMed Topical Anesthetic 7 | LIDOCAINE HYDROCHLORIDE | Sambria Pharmaceuticals | 67b25c37-db32-4980-88b0-b07712345939 | 2025-11-12 | Warnings | M017 |
| NeuroMed Topical Analgesic LA | TETRACAINE HCL | Sambria Pharmaceuticals, Inc. | 3c1e3a1d-f42b-499d-a445-1d1d3dd26c19 | 2025-11-12 | Warnings | M017 |
| NeuroMed FA | BENZOCAINE | Sambria Pharmaceuticals, Inc. | 97345ed4-51c3-4221-852c-2cd563f33317 | 2025-11-12 | Warnings | M017 |
| ZHENG GU SHUI | CAMPHOR, MENTHOL | GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD | 17552943-4f11-42d6-ad41-fbc53f2bbd9a | 2025-11-12 | Warnings, Adverse reactions | M017 |
| NeuroMed FA | BENZOCAINE | Sambria Pharmaceuticals, Inc. | 605fc242-ad31-4aa9-bd86-fba4ddf0d305 | 2025-11-12 | Warnings | M017 |
| CAPZIX | CAPSAICIN | Toprail Chp Llc. | a4555840-cf8f-45d8-90bb-3581102b58a7 | 2025-11-12 | 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 |