SORE NO MORE WARM THERAPY
- Product NDC
- 61577-3234
- 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 product | product | 61577-3234 | D | Discontinued by firm | 2026-10-16 | ||
| excluded package | package | 61577-3234 | 61577-3234-2 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 61577-3234 | 61577-3234-3 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 61577-3234 | 61577-3234-4 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 61577-3234 | 61577-3234-5 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 61577-3234 | 61577-3234-6 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 61577-3234 | 61577-3234-7 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 61577-3234 | 61577-3234-9 | D | Discontinued by firm | 2026-10-16 |
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 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 61577-3234-4 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 61577-3234-2 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 61577-3234-7 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 61577-3234-3 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 61577-3234-6 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 61577-3234-5 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 61577-3234-9 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 61577-3234-4 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 61577-3234-2 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 61577-3234-7 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 61577-3234-3 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 61577-3234-6 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 61577-3234-5 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 61577-3234-9 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… | |
| 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 | 61577-3234-4 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 61577-3234-9 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 61577-3234-2 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 61577-3234-5 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 61577-3234-7 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 61577-3234-3 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 61577-3234-6 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 61577-3234-6 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 61577-3234-7 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 61577-3234-2 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 61577-3234-4 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 61577-3234-5 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 61577-3234-8 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 61577-3234-3 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 61577-3234-9 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… | |
| 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 | 61577-3234-4 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 61577-3234-9 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 61577-3234-2 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 61577-3234-5 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 61577-3234-7 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 61577-3234-3 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 61577-3234-6 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 61577-3234-6 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 61577-3234-7 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 61577-3234-2 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 61577-3234-4 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 61577-3234-5 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 61577-3234-8 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 61577-3234-3 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 61577-3234-9 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… | |
| 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 | 61577-3234-4 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 61577-3234-9 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 61577-3234-2 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 61577-3234-5 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 61577-3234-7 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 61577-3234-3 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 61577-3234-6 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 61577-3234-6 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
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.
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 |
|---|---|---|---|---|---|---|---|---|
| 61577-3234-2 | 61577323402 | 907.2 g in 1 BOTTLE, PUMP (61577-3234-2) | 907.2 g | 2016-06-14 | 0000-00-00 | No | No | Current |
| 61577-3234-3 | 61577323403 | 226.8 g in 1 JAR (61577-3234-3) | 226.8 g | 2016-06-14 | 0000-00-00 | No | No | Current |
| 61577-3234-4 | 61577323404 | 113.4 g in 1 JAR (61577-3234-4) | 113.4 g | 2016-06-14 | 0000-00-00 | No | No | Current |
| 61577-3234-5 | 61577323405 | 85 g in 1 BOTTLE, PLASTIC (61577-3234-5) | 85 g | 2016-06-14 | 0000-00-00 | No | No | Current |
| 61577-3234-6 | 61577323406 | 113.4 g in 1 TUBE (61577-3234-6) | 113.4 g | 2016-06-14 | 0000-00-00 | No | No | Current |
| 61577-3234-7 | 61577323407 | 56.7 g in 1 JAR (61577-3234-7) | 56.7 g | 2016-06-14 | 0000-00-00 | No | No | Current |
| 61577-3234-8 | 61577323408 | 28.3 g in 1 PACKAGE (61577-3234-8) | 28.3 g | 2017-06-01 | 0000-00-00 | Yes | No | Current |
| 61577-3234-9 | 61577323409 | 5 g in 1 POUCH (61577-3234-9) | 5 g | 2016-06-14 | 0000-00-00 | No | No | Current |