SORE NO MORE WARM THERAPY
- Product NDC
- 61577-3234
- Requested package NDC
- 61577-3234-5
- 11-digit product format
- 615773234
- Labeler code
- 61577
- Product ID
- 61577-3234_34f862b6-eefe-92fc-e063-6294a90a5242
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- MENTHOL and CAMPHOR
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- SOMBRA COSMETICS INC.
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-06-13
- Substance
- MENTHOL; CAMPHOR (SYNTHETIC)
- Active strength
- .03; .03 g/g; g/g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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 | 61577-3234 | 61577-3234-5 | D | Discontinued by firm | 2026-09-14 |
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 |
|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
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 WARM THERAPY
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL | .03 g/g |
| CAMPHOR (SYNTHETIC) | .03 g/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
| 5TJD82A1ET | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 630714 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| cd86b56e-9b4c-4aca-9740-c8793cb12055 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 111d457e-3138-4512-b0ba-d0cd760c4055 | Product name | 3 | 20250225 |
| 0426261e-1bb9-b78b-abd2-80da765a7e3e | Product name | 2 | 20240513 |
| 7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7 | Product name | 5 | 20240320 |
| 0ac2f11f-f58d-baf2-71a0-680993b48a61 | Product name | 2 | 20231211 |
| 855d63c3-b090-4636-8fc7-6d39ad23c44f | Product name | 1 | 20230829 |
| bb58f410-04be-65dd-9211-e89ead899698 | Product name | 6 | 20230323 |
| 0fcbc38a-8b29-3348-1cef-5222ea53484f | Product name | 4 | 20220516 |
| c4e1eedc-aca2-4551-8382-89144ed9d049 | Product name | 3 | 20220126 |
| 8d368a34-1453-43ea-828d-0dbcd72b8794 | Product name | 8 | 20210622 |
| 473d070d-1c38-488e-b991-c4d1bf45aab8 | Product name | 1 | 20210201 |
| d6bab9d2-edce-a213-4796-226ab15472c3 | Product name | 6 | 20200616 |
| 2487e6ef-d419-42fc-aaf8-7acc805d2370 | Product name | 2 | 20170718 |
| e071c814-e5e7-e7ed-ec76-428765d9c66b | Product name | 2 | 20151120 |
| 93148e06-b8d7-4e6c-853e-62f807d17fbb | Product name | 1 | 20151014 |
| dbb00be6-fb1c-4b0a-a770-31f7e05e247e | Product name | 1 | 20150316 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61577-3234-2 | SORE NO MORE WARM THERAPY | 907.2 g in 1 BOTTLE, PUMP | GEL | 907.2 | 9 | |
| 61577-3234-3 | SORE NO MORE WARM THERAPY | 226.8 g in 1 JAR | GEL | 226.8 | 9 | |
| 61577-3234-4 | SORE NO MORE WARM THERAPY | 113.4 g in 1 JAR | GEL | 113.4 | 9 | |
| 61577-3234-5 | SORE NO MORE WARM THERAPY | 85 g in 1 BOTTLE, PLASTIC | GEL | 85 | 9 | |
| 61577-3234-6 | SORE NO MORE WARM THERAPY | 113.4 g in 1 TUBE | GEL | 113.4 | 9 | |
| 61577-3234-7 | SORE NO MORE WARM THERAPY | 56.7 g in 1 JAR | GEL | 56.7 | 9 | |
| 61577-3234-8 | SORE NO MORE WARM THERAPY | 28.3 g in 1 PACKAGE | GEL | 28.3 | 9 | |
| 61577-3234-9 | SORE NO MORE WARM THERAPY | 5 g in 1 POUCH | GEL | 5 | 9 | |
| 61577-3234-5 | Inflatherm | 85 g in 1 BOTTLE, PLASTIC | GEL | 85 g | 0.03 g in 1g | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61577-3234 | SORE NO MORE WARM THERAPY (MENTHOL AND CAMPHOR) GEL [SOMBRA COSMETICS INC.] | 9 | Current NDC, Legacy NDC, 8 package rows | 20250514_cd86b56e-9b4c-4aca-9740-c8793cb12055.zip |
| 61577-3234 | INFLATHERM (DICLOFENAC SODIUM AND MENTHOL / CAMPHOR GEL) KIT [V2 PHARMA, LLC] | 6 | Current NDC, Legacy NDC | 20240820_b62f4306-8dbd-4501-8b1e-9aa78f9aee06.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 |
|---|---|---|---|---|---|---|
| JenGufun LIDOCAINE KNEE Patch | LIDOCAINE KNEE PATCH | Henan Kangdi Medical Devices Co., Ltd. | 5b1d8508-b993-7a8d-e063-6294a90ae306 | 2026-09-10 | Warnings | M017 |
| Wart Corn Remover | SALICYLIC ACID | HONG KONG FOREVER YOUNG TRADING CO., LIMITED | 5b0cd6e0-f220-4ebd-e063-6294a90ade67 | 2026-09-09 | Warnings | M017 |
| Magic Cream | PAIN RELIEVING OINTMENT | Jiangxi Baikang Medical Products Co., Ltd. | 5b0f2515-47e9-603f-e063-6294a90af9d4 | 2026-09-09 | Warnings | M017 |
| Burn Gel | LIDOCAINE HCI | Trifecta Pharmaceuticals USA LLC | e9d3e9be-1036-fad0-e053-2a95a90a6efe | 2026-09-09 | Warnings | M017 |
| 4% Lidocaine Pain Relief Patch | LIDOCAINE 4% | Guangxi Keyun E-commerce Co., Ltd. | 5b197cd8-542f-38b4-e063-6294a90ad7d3 | 2026-09-09 | Warnings | M017 |
| Pain Relieving Lidocaine Patch | LIDOCAINE | YYBA CORP | af8c84fd-224c-72b3-e053-2a95a90a9568 | 2026-09-07 | Warnings | M017 |
| American Safety First Aid | LIDOCAINE HCL | Orazen Inc | ea2f776b-dfd0-6ce4-e053-2995a90af009 | 2026-09-07 | Warnings | M017 |
| MEDI-FIRST Topical Analgesic | LIDOCAINE HCI | Ultra Distributors Inc | b6f288f7-9ae3-215e-e053-2a95a90aedf6 | 2026-09-07 | Warnings | M017 |
| MEDI-FIRST | BENZALKONIUM CHLORIDE, LIDOCAINE | Orazen Inc | f508434f-5948-7134-e053-2a95a90a03d7 | 2026-09-05 | Warnings | M017 |
| MEDI-FIRST | BENZALKONIUM CHLORIDE, LIDOCAINE | Orazen Inc | f522fb0b-3d86-b228-e053-2a95a90a55e9 | 2026-09-05 | Warnings | M017 |
| SurviveX Anti-itch Cream | SURVIVEX HYDROCORTISONE | Nantong Health & Beyond Hygienic Products Inc. | 5a7a1141-d3b1-0ee8-e063-6294a90a16aa | 2026-09-04 | Warnings | M017 |
| NeuroNesic Pain Relieving Cream | CAPSAICIN | Blaine Labs Inc. | 7107c13d-bf59-4c0a-84fe-725a9fca2691 | 2026-09-04 | Warnings | M017 |
| Neoteric Diabetic Skin Care 1 oz. | DIMETHICONE | RNA PHARMA LLC | 5a944486-9591-f583-e063-6394a90aa04b | 2026-09-03 | Warnings | M017 |
| Equate Menthol Pain Relieving | MENTHOL | Wal-Mart Stores Inc | d5b0a7f1-4e23-426b-bb7e-aaa251ad4ffc | 2026-09-03 | Warnings | M017 |
| ZHI Technologies | LIDOCAINE, MENTHOL | ZHI Technologies, Inc. | 6717e995-4d2d-49e8-8ecf-7c62557dfdef | 2026-09-03 | Warnings | M017 |
| Komxsum LIDOCAINE Cream | LIDOCAINE 4% CREAM | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 5a9feae0-9be4-e736-e063-6294a90abe55 | 2026-09-03 | Warnings | M017 |
| FREEZE EASE Roll-On | MENTHOL | Global America Group LLC | 1869cc0d-a056-45de-aede-23b09b61ed12 | 2026-09-02 | Warnings | M017 |
| Gaimoa Lidocaine Pain Relief Gel Patches | LIDOCAINE PAIN RELIEF GEL PATCHES | Henan Enokon Medical Instrument Co., Ltd. | 5a68fe67-5c15-af9a-e063-6294a90a7ec1 | 2026-09-01 | Warnings | M017 |
| CVS Cortisone Liquid | HYDROCORTISONE | CVS Pharmacy | 42df45a9-d449-090a-e063-6394a90a9ee4 | 2026-09-01 | Warnings | M017 |
| Ramedica Herbal Wonder Balm | CAMPHOR, MENTHOL | Ramedicare Sdn. Bhd. | cfb2ea0e-a1f6-4fdf-b866-346bbe78788f | 2026-09-01 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 630714 | camphor 3 % / menthol 3 % Topical Gel | PSN | cd86b56e-9b4c-4aca-9740-c8793cb12055 | 9 |
| 630714 | camphor 0.03 MG/MG / menthol 0.03 MG/MG Topical Gel | SCD | cd86b56e-9b4c-4aca-9740-c8793cb12055 | 9 |
| 630714 | camphor 3 % / menthol 3 % Topical Gel | SY | cd86b56e-9b4c-4aca-9740-c8793cb12055 | 9 |
| 630714 | camphor 3 % / menthol 3 % Topical Gel | PSN | b62f4306-8dbd-4501-8b1e-9aa78f9aee06 | 6 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | b62f4306-8dbd-4501-8b1e-9aa78f9aee06 | 6 |
| 630714 | camphor 0.03 MG/MG / menthol 0.03 MG/MG Topical Gel | SCD | b62f4306-8dbd-4501-8b1e-9aa78f9aee06 | 6 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | b62f4306-8dbd-4501-8b1e-9aa78f9aee06 | 6 |
| 630714 | camphor 3 % / menthol 3 % Topical Gel | SY | b62f4306-8dbd-4501-8b1e-9aa78f9aee06 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61577-3234-5 | 61577323405 | 85 g in 1 BOTTLE, PLASTIC (61577-3234-5) | 85 g | 2016-06-14 | 0000-00-00 | No | No | Current |