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 |
|---|---|---|---|---|---|---|
| HEEL PAIN RELIEF ROLL-ON | LIDOCAINE AND MENTHOL | Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. | 4c06c4a4-557b-8bb1-e063-6294a90a9125 | 2026-03-02 | Warnings | M017 |
| Sunburn Relief | LIDOCAINE HCL 0.5% | Old East Main Co. | 49173ec8-c94a-44c9-8a13-0f4b01b96cd6 | 2026-03-02 | Warnings, Adverse reactions | M017 |
| Itch Relief | DIPHENHYDRAMINE HCL, ZINC ACETATE | Old East Main Co. | 6d87547f-bf4c-4dda-bd9d-32b576afd805 | 2026-03-02 | Warnings, Adverse reactions | M017 |
| Still Standing | MENTHOL, UNSPECIFIED FORM | Natural Essentials Inc. | 66974aaf-c82f-4fe9-bfb3-3430b80ac9f2 | 2026-03-02 | Warnings | M017 |
| Lightning Pain Relief | MENTHOL | Clinical Resolution Laboratory, Inc. | 80af21f5-dba8-42b0-8a65-ac5a94d83ca8 | 2026-03-02 | Warnings | M017 |
| Icy Hot Lidocaine No-Mess | LIDOCAINE HYDROCHLORIDE | Chattem, Inc. | 347f9a18-8ab6-47d3-9610-5b4e9ca5d53a | 2026-03-02 | Warnings | M017 |
| Gold Bond Maximum Strength Foot Pain Relief | LIDOCAINE HYDROCHLORIDE | Gold Bond Co LLC | 8e469076-2f5a-4de8-8d13-a38c072b9af8 | 2026-03-01 | Warnings | M017 |
| HealthWise Pain Relief Lidocaine | LIDOCAINE HYDROCHLORIDE | Veridian Healthcare | 48ecbab9-13e0-d0fa-e063-6294a90a6ff2 | 2026-02-28 | Warnings | M017 |
| NUMBING CREAMS | LIDOCAINE | Yongchun Lihui Trading Co., Ltd. | 3b5e1a74-5946-4f1f-e063-6394a90a404b | 2026-02-27 | Warnings | M017 |
| Pain Relieving Gel | LIDOCAINE HYDROCHLORIDE | Chain Drug Marketing Association | b55b7253-2fd2-45cc-b94c-e92395ab0d2b | 2026-02-27 | Warnings, Adverse reactions | M017 |
| MEDISTIK PROFESSIONAL DUAL ACTION | MENTHOL, METHYL SALICYLATE, EUCALUPTUS | Natureteq Inc. | 99c7f08a-ab14-4371-9147-189f75cb6633 | 2026-02-27 | Warnings | M017 |
| Aloe Vera Gel | LIDOCAINE HCL, MENTHOL | Walmart Inc. | 309dcf5b-7166-976a-e063-6394a90af952 | 2026-02-27 | Warnings, Adverse reactions | M017 |
| ASYSTEM Radical Relief Gel Roll-On | MENTHOL, METHYL SALICYLATE | Cosco International, Inc. | 7239733e-5510-4a63-96c3-dd88b4a431a3 | 2026-02-27 | Warnings | M017 |
| Icy Hot Pro Pain Massaging Balm | CAMPHOR AND MENTHOL | Chattem, Inc. | 09e2b0cb-5186-4f9c-b256-edaced4ca014 | 2026-02-27 | Warnings | M017 |
| Lidocaine Pain Relief | LIDOCAINE PAIN RELIEF | PAI Holdings, LLC dba PAI Pharma | 963978de-8295-47ee-9b06-64c3521aa994 | 2026-02-26 | Warnings | M017 |
| Tommie Copper Cooling Roller Lavender Scent | MENTHOL 4% | Tommie Copper, Inc. | 4bbfd4d1-9036-bc20-e063-6394a90a3feb | 2026-02-26 | Warnings | M017 |
| HQLSEY QUIT SMOKING PATCHES | QUIT SMOKING PATCHES | Hansen Pharmaceutical Investment Co., Limited | 4ba317fb-714a-05cb-e063-6394a90a382f | 2026-02-25 | Warnings | M017 |
| Advanced Pain Relief Cream With 5 % Natural Menthol | MENTHOL | Allure Labs | 4bab9c43-86d4-dad2-e063-6394a90ac095 | 2026-02-25 | Warnings | M017 |
| Walgreens Pain Relieving Patch | MENTHOL, CAMPHOR, METHYL SALICYLATE | Walgreen Co. | 4223c74a-12fb-51a3-e063-6294a90a0deb | 2026-02-25 | Warnings | M017 |
| Advanced Pain Relief Roll-On Gel With 5% Natural Menthol | MENTHOL | Allure Labs | 4bad597f-acb2-a122-e063-6394a90a9fcf | 2026-02-25 | 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 |