SORE NO MORE COOL THERAPY
- Product NDC
- 61577-3235
- 11-digit product format
- 615773235
- Labeler code
- 61577
- Product ID
- 61577-3235_3622f4f5-48bf-9035-e063-6294a90afac2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- MENTHOL
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- SOMBRA COSMETICS INC.
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-06-14
- Substance
- MENTHOL
- Active strength
- .06 g/g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 61577-3235-6 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 61577-3235-7 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 61577-3235-4 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 61577-3235-9 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 61577-3235-1 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 61577-3235-5 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 61577-3235-2 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 61577-3235-8 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 61577-3235-6 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 61577-3235-7 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 61577-3235-4 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 61577-3235-9 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 61577-3235-1 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 61577-3235-5 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 61577-3235-2 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 61577-3235-8 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 61577-3235-6 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 61577-3235-7 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 61577-3235-4 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 61577-3235-9 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 61577-3235-1 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 61577-3235-5 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 61577-3235-2 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 61577-3235-8 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 61577-3235-6 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 61577-3235-7 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 61577-3235-4 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 61577-3235-9 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 61577-3235-1 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 61577-3235-5 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 61577-3235-2 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 61577-3235-8 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 61577-3235-5 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 61577-3235-7 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 61577-3235-6 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 61577-3235-2 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 61577-3235-8 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 61577-3235-9 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 61577-3235-1 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 61577-3235-4 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 61577-3235-5 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 61577-3235-7 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 61577-3235-6 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 61577-3235-2 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 61577-3235-8 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 61577-3235-9 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 61577-3235-1 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 61577-3235-4 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 61577-3235-5 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 61577-3235-7 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 61577-3235-6 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 61577-3235-2 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 61577-3235-8 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
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
- SORE NO MORE COOL THERAPY
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL | .06 g/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 415976 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9aa1f0ac-3baf-4e45-9e3a-c28a99b22909 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61577-3235-1 | SORE NO MORE COOL THERAPY | 226.8 g in 1 JAR | GEL | 226.8 | 12 | |
| 61577-3235-2 | SORE NO MORE COOL THERAPY | 907.2 g in 1 BOTTLE, PUMP | GEL | 907.2 | 12 | |
| 61577-3235-4 | SORE NO MORE COOL THERAPY | 113.4 g in 1 JAR | GEL | 113.4 | 12 | |
| 61577-3235-5 | SORE NO MORE COOL THERAPY | 85 g in 1 BOTTLE, PLASTIC | GEL | 85 | 12 | |
| 61577-3235-6 | SORE NO MORE COOL THERAPY | 113.4 g in 1 TUBE | GEL | 113.4 | 12 | |
| 61577-3235-7 | SORE NO MORE COOL THERAPY | 56.7 g in 1 JAR | GEL | 56.7 | 12 | |
| 61577-3235-8 | SORE NO MORE COOL THERAPY | 28.3 g in 1 JAR | GEL | 28.3 | 12 | |
| 61577-3235-9 | SORE NO MORE COOL THERAPY | 5 g in 1 POUCH | GEL | 5 | 12 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61577-3235 | SORE NO MORE COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.] | 12 | Current NDC, Legacy NDC, 8 package rows | 20250529_9aa1f0ac-3baf-4e45-9e3a-c28a99b22909.zip |
| 61577-3235 | ELEMAR PATCH (LIDOCAINE) KIT [V2 PHARMA, LLC] | 11 | Current NDC, Legacy NDC | 20250101_3de6bb95-3673-45c4-bf11-90ec858c37d9.zip |
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 |
|---|---|---|---|---|---|---|
| blue goo Pain Relieving | MENTHOL 2.5% | Garcoa, Inc. | 7b9b5ac6-9568-464c-8096-0302a1e650df | 2026-02-13 | Warnings | M017 |
| Methyl Salicylate 30 Percent Cream | METHYL SALICYLATE | Alexso, Inc | 1d50ccb2-1a5d-49c7-8524-2f54eed63e85 | 2026-02-13 | Warnings | M017 |
| Antiseptic Mouth Rinse | EUCALYPTOL, MENTHOL, METHYOL SALICYLATE, THYMOL | Topco Associates LLC | a38e91c1-7ac6-4a7f-a5a2-8d9166b1535a | 2026-02-13 | Warnings, Adverse reactions | M017 |
| Gel Cooling Pain Relief | MENTHOL | Topco Associates LLC | 80962394-a46f-48fd-8e0c-685dd1e500d7 | 2026-02-13 | Warnings, Adverse reactions | M017 |
| Banophen | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | Major Pharmaceuticals | 9758d886-bd58-4eb2-a827-fa8e7fee2b7c | 2026-02-13 | Warnings | M017 |
| Natureplex Hydrocortisone Hydro | HYDROCORTISONE | Natureplex, LLC | 2fc6a148-34bb-4289-8588-32c1bb011b98 | 2026-02-13 | Warnings | M017 |
| Capsaicin 0.035 Percent | CAPSAICIN | Alexso, Inc | 6d0bc1cc-e812-4753-b20c-c0357dd6deb5 | 2026-02-13 | Warnings | M017 |
| Swiftalyn Numbing Cream | LIDOCAINE 4% | GENUINE INNOVATION LTD | 3f74c4a6-26f0-ddf7-e063-6394a90a1225 | 2026-02-12 | Warnings | M017 |
| PHARMBANNER Arnica Bruise Cream | ARNICA BRUISE CREAM | Shenzhen Xinxin Yunhai Technology Co., Ltd. | 3c783061-8e2d-8a84-e063-6394a90a5265 | 2026-02-12 | Warnings | M017 |
| ETERNAL SPIRIT BEAUTY PAIN RELIEF WITH HEMP | MENTHOL, CAMPHOR | Worldwide Cosmetics, Inc | 459d64a9-0538-57c8-e063-6394a90a6155 | 2026-02-12 | Warnings | M017 |
| Antiseptic Mouth Rinse | EUCALYPTOL | Walgreen Co. | cba60e9d-5f12-4c56-9fa5-6ce1514fc2b0 | 2026-02-12 | Warnings, Adverse reactions | M017 |
| Medicated Body Powder | MENTHOL | Walmart Stores Inc | afd337b7-d76e-f17a-e053-2a95a90abac7 | 2026-02-12 | Warnings | M017 |
| Lidocaine Hydrochloride 2% | LIDOCAINE HYDROCHLORIDE | Aldermed Inc. | 4977b722-d08d-3d9e-e063-6294a90a9035 | 2026-02-12 | Warnings | M017 |
| Ice Gel ICE COLD ANALGESIC | MENTHOL | Jell Pharmaceuticals Pvt Ltd | 4a8b3f84-8c45-eb94-e063-6394a90a3e73 | 2026-02-11 | Warnings | M017 |
| Walgreens Pain Relieving Lidocaine Patch | LIDOCAINE | Walgreen Co. | 41c4e9fe-e407-b22a-e063-6394a90a4b27 | 2026-02-10 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE CREAM 1% | Aldermed Inc. | 4a7f2c0e-5cf3-29cb-e063-6394a90a5d8d | 2026-02-10 | Warnings | M017 |
| MENTHOL, CAMPHOR | MENTHOL, CAMPHOR | SUNSET PAIN RELIEF | 4a7f92d3-dd35-44a3-e063-6294a90ae004 | 2026-02-10 | Warnings | M017 |
| NICOVITO HEMORRHOID MASTER | LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID MASTER | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a5e24fa-959e-79b4-e063-6294a90a8f68 | 2026-02-09 | Warnings | M017 |
| Tiger Balm Active Muscle Rub | METHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC) | Haw Par Healthcare Ltd. | 2e7638c6-e1ce-4e2f-bd50-52fbce5a138e | 2026-02-09 | Warnings | M017 |
| Tiger Balm Neck and Shoulder Rub | CAMPHOR (SYNTHETIC) AND MENTHOL | Haw Par Healthcare Ltd. | 2f272d12-7b34-430e-817e-1005f57ed9e9 | 2026-02-09 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 415976 | menthol 6 % Topical Gel | PSN | 9aa1f0ac-3baf-4e45-9e3a-c28a99b22909 | 12 |
| 415976 | menthol 0.06 MG/MG Topical Gel | SCD | 9aa1f0ac-3baf-4e45-9e3a-c28a99b22909 | 12 |
| 415976 | menthol 6 % Topical Gel | SY | 9aa1f0ac-3baf-4e45-9e3a-c28a99b22909 | 12 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61577-3235-1 | 61577323501 | 226.8 g in 1 JAR (61577-3235-1) | 226.8 g | 2016-06-14 | 0000-00-00 | No | No | Current |
| 61577-3235-2 | 61577323502 | 907.2 g in 1 BOTTLE, PUMP (61577-3235-2) | 907.2 g | 2016-06-14 | 0000-00-00 | No | No | Current |
| 61577-3235-4 | 61577323504 | 113.4 g in 1 JAR (61577-3235-4) | 113.4 g | 2016-06-14 | 0000-00-00 | No | No | Current |
| 61577-3235-5 | 61577323505 | 85 g in 1 BOTTLE, PLASTIC (61577-3235-5) | 85 g | 2016-06-14 | 0000-00-00 | No | No | Current |
| 61577-3235-6 | 61577323506 | 113.4 g in 1 TUBE (61577-3235-6) | 113.4 g | 2016-06-14 | 0000-00-00 | No | No | Current |
| 61577-3235-7 | 61577323507 | 56.7 g in 1 JAR (61577-3235-7) | 56.7 g | 2016-06-14 | 0000-00-00 | No | No | Current |
| 61577-3235-8 | 61577323508 | 28.3 g in 1 JAR (61577-3235-8) | 28.3 g | 2017-07-02 | 0000-00-00 | Yes | No | Current |
| 61577-3235-9 | 61577323509 | 5 g in 1 POUCH (61577-3235-9) | 5 g | 2016-06-14 | 0000-00-00 | No | No | Current |