SORE NO MORE COOL THERAPY
- Product NDC
- 61577-3235
- Requested package NDC
- 61577-3235-9
- 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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|
| 2025-04-01 02:39 UTC · source 2025-03-31 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
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 |
|---|---|---|---|---|---|---|
| Itch Relief | DIPHENHYDRAMINE HCL, ZINC ACETATE | Cardinal Health, 110 dba Leader | 3ed7b8a1-012f-459d-878c-813b93d4673c | 2026-08-06 | Warnings, Adverse reactions | M017 |
| Gel Cooling Pain Relief | MENTHOL | The Kroger Co. | 6fb0acc8-8dab-452c-b09e-de97306e1c32 | 2026-08-06 | Warnings, Adverse reactions | M017 |
| Lidocaine Tattoo Wipe | LIDOCAINE HYDROCHLORIDE | MD Tattoo Company | 369c1d16-597c-e1dc-e063-6394a90a3104 | 2026-08-06 | Warnings | M017 |
| Point Relief Coldspot Pain Relieving | MENTHOL | Fabrication Enterprises Inc | 479fb728-4aeb-42e3-b238-f04255514baa | 2026-08-05 | Warnings | M017 |
| Lidocaine HCl | LIDOCAINE HCL | Topco Associates LLC | 584e1f35-4d99-9c85-e063-6294a90ab3d0 | 2026-08-05 | Warnings, Adverse reactions | M017 |
| tuiwaro LIDOCAINE Cream | LIDOCAINE CREAM | Guangzhou Jingliang Cosmetics Co., Ltd. | 56e36592-a935-61d4-e063-6294a90a6e4c | 2026-08-04 | Warnings | M017 |
| Mineral Ice Extreme Menthol Pain Relief | MENTHOL | Carlin Consumer Health LLC | 584f5c6e-3385-3221-e063-6294a90aabae | 2026-08-04 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | Bryant Ranch Prepack | 484fe5e4-a058-49c0-a382-c8fc3e20c3b2 | 2026-08-04 | Warnings | M017 |
| procure | HYDROCORTISONE ACETATE | TWIN MED, LLC | 2670c9c4-66ad-40e8-a08a-582b160de39d | 2026-08-03 | Warnings | M017 |
| Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll On | MENTHOL | Chattem, Inc. | aa40c907-eeb5-4fda-b35e-439cbecc178c | 2026-07-31 | Warnings | M017 |
| Alphamale Delay Cream | BENZOCAINE | Prodigy Media Inc | 53d682ee-0802-a16d-e063-6394a90aeee1 | 2026-07-31 | Warnings | M017 |
| Pure Primal Delay Cream | BENZOCAINE | Prodigy Media Inc | 57e9e894-c14f-d806-e063-6394a90ab8e5 | 2026-07-31 | Warnings | M017 |
| Satohap | DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE | Sato Pharmaceutical Co., Ltd. | df0e2b83-8f61-4ed8-bcc4-55e4ea782090 | 2026-07-31 | Warnings | M017 |
| Satogesic | DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE | Sato Pharmaceutical Co., Ltd. | cb000134-92a4-4304-8ef0-0347190e1414 | 2026-07-31 | Warnings | M017 |
| Satogesic Hot | CAPSAICIN | Sato Pharmaceutical Co., Ltd. | 16b47cb5-ea5f-4514-9a89-141ee4cc60f8 | 2026-07-31 | Warnings | M017 |
| Satohap Cool and Hot Pads | CAMPHOR, CAPSAICIN, MENTHOL | Sato Pharmaceutical Co., Ltd. | b6bf1eab-4ab9-f500-e053-2995a90a8d7b | 2026-07-31 | Warnings, Adverse reactions | M017 |
| SATOHAP COOL and HOT | CAMPHOR, CAPSAICIN, MENTHOL | Sato Pharmaceuticals Co., Ltd. | 232a4c76-1a0c-2f4b-e063-6394a90a8849 | 2026-07-31 | Warnings, Adverse reactions | M017 |
| Cortizone 10 Itch Relief Massaging Rollerball | HYDROCORTISONE | Chattem, Inc. | 1e27682c-f856-41f1-9935-37540960a4c7 | 2026-07-31 | Warnings | M017 |
| Aspercreme with Lidocaine Dry | LIDOCAINE | Chattem, Inc. | 008abaaa-5e12-4246-a7f5-66f3966acf28 | 2026-07-30 | Warnings | M017 |
| ACOLYE Lidocaine Cream Topical Analgesia Cream | LIDOCAINE,MENTHOL | Guangdong Aimu Biological Technology Co., Ltd | 57deebf7-52f1-4256-e063-6294a90a75d5 | 2026-07-30 | 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 |
|---|---|---|---|---|---|---|---|---|
| 61577-3235-9 | 61577323509 | 5 g in 1 POUCH (61577-3235-9) | 5 g | 2016-06-14 | 0000-00-00 | No | No | Current |