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 |
|---|---|---|---|---|---|---|
| Gaayou Numbing | DIBUCAINE HYDROCHLORIDE 0.5% NUMBING | Jiangxi Yudexi Pharmaceutical Co., LTD | 4c290118-7880-2a98-e063-6294a90a4c03 | 2026-07-21 | Warnings | M017 |
| Professional Therapy MuscleCare Pain Relieving Cold Gel | CAMPHOR, MENTHOL | Active and Innovative | 572792bb-2819-36c3-e063-6394a90aa504 | 2026-07-21 | Warnings | M017 |
| SYLVIRENE NUMBING | LIDOCAINE 4% NUMBING | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a36edc5-5a89-afb5-e063-6294a90a02dd | 2026-07-21 | Warnings | M017 |
| REINREUDE PROVIDES TEMPORARY RELIEF FOR MINOR MUSCLE AND JOINT PAIN | LIDOCAINE 4% PROVIDES TEMPORARY RELIEF FOR MINOR MUSCLE AND JOINT PAIN | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a45c1cb-c5ab-d872-e063-6394a90aab5d | 2026-07-21 | Warnings | M017 |
| SERYNTH Muscle Comfort | ARNICA MONTANA HPUS 7% MUSCLE COMFORT | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a4c10cd-f0c4-8731-e063-6394a90a10a5 | 2026-07-21 | Warnings | M017 |
| DERMFREE MEDICATED LIP | CAMPHOR 2.0% MEDICATED LIP | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a4d62fb-8dfa-404a-e063-6294a90a385d | 2026-07-21 | Warnings | M017 |
| NATUHEAL RELIEF Cream FOR ECZEMA | HYDROCORTISONE ACETATE 1% RELIEF CREAM FOR ECZEMA | Jiangxi Yudexi Pharmaceutical Co., LTD | 4c92fed1-a8b4-bda8-e063-6394a90a8a33 | 2026-07-20 | Warnings | M017 |
| REDCOOL Arnica Bruise | ARNICA MONTANA HPUS 7% ARNICA BRUISE | Jiangxi Zhongletang Pharmaceuticals Co.,Ltd. | 49911392-e55e-1a6b-e063-6394a90a9af0 | 2026-07-20 | Warnings | M017 |
| Vamy HEMORRHOID | LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID | Jiangxi Yudexi Pharmaceutical Co., LTD | 499197aa-f872-3abf-e063-6294a90aeda2 | 2026-07-20 | Warnings | M017 |
| Subleef NUMBING | LIDOCAINE4% NUMBING | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a201a6b-adde-c0a8-e063-6394a90a8285 | 2026-07-20 | Warnings | M017 |
| PUVIDA NUMBING | MENTHOL 5% (W/W) NUMBING | Jiangxi Yudexi Pharmaceutical Co., LTD | 4de4e317-2f4f-e5d6-e063-6394a90a0611 | 2026-07-20 | Warnings | M017 |
| Careland Lidocaine Plus Menthol Pain Relieving Gel Patches | LIDOCAINE, MENTHOL | Planet (Anhui) Pharmaceutical Co., Ltd. | 8b607c03-a98f-445a-a69e-7625a76ac44b | 2026-07-20 | Warnings | M017 |
| Yodo Salil | OINTMENT | Laboratorio Neo Farmaco del Ecuador Neofarmaco Cia. LTDA. | 56812625-7eab-6a25-e063-6294a90a23fe | 2026-07-20 | Warnings | M017 |
| VBBV Numbing | LIDOCAINE | Jiashen International Trade Limited | 5716c36b-6e97-c294-e063-6394a90aaf5c | 2026-07-20 | Warnings | M017 |
| Burn Relief | LIDOCAINE | Premier Brands of America Inc. | 560c29cc-2453-5d14-e063-6394a90a844f | 2026-07-17 | Warnings | M017 |
| 4% Lidocaine Pain Relief Patch | LIDOCAINE 4% | Guangxi Keyun E-commerce Co., Ltd. | 4981e9c3-2a19-aed8-e063-6294a90af216 | 2026-07-17 | Warnings | M017 |
| endurance wipe | BENZOCAINE | Absorption Pharmaceuticals, LLC | 303db1de-94fc-4543-e063-6294a90a01b9 | 2026-07-17 | Warnings | M017 |
| Professional Therapy MuscleCare pain relieving gel Extra Strength | CAMPHOR, MENTHOL | Active and Innovative Inc. | 56d30c33-ef5a-c63d-e063-6294a90acd29 | 2026-07-17 | Warnings | M017 |
| Mineral Ice Extreme Gel Alpine Fresh Scent | MENTHOL | Carlin Consumer Health LLC | 56d3ca3d-21e1-a40a-e063-6294a90a9ff4 | 2026-07-17 | Warnings | M017 |
| DRAVYNOR TOPICAL ANALGESIC HEAT Patch | MENTHOL 24MG CAPSAICIN 16MG TOPICAL ANALGESIC HEAT PATCH | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 56b83ee8-8d86-9436-e063-6294a90a0c25 | 2026-07-16 | 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 |