Soothe And Cool Treat
- Product NDC
- 53329-080
- 11-digit product format
- 533290080
- Labeler code
- 53329
- Product ID
- 53329-080_e9c0d6a1-f897-61ae-e053-2995a90aeabc
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Miconazole Nitrate
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Medline Industries, LP
- Application
- M005
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2007-01-01
- Marketing end
- 0000-00-00
- Substance
- MICONAZOLE NITRATE
- Active strength
- 20 mg/100g
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 | 53329-080 | D | Discontinued by firm | 2026-10-05 | ||
| excluded product | product | 53329-080 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 53329-080 | 53329-080-57 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 53329-080 | 53329-080-58 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 53329-080 | 53329-080-57 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 53329-080 | 53329-080-58 | D | Discontinued by firm | 2026-10-05 |
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 | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 53329-080-58 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 53329-080-58 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 53329-080-57 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 53329-080-57 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 53329-080-58 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 53329-080-58 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 53329-080-57 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 53329-080-57 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 53329-080-58 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 53329-080-58 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 53329-080-57 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 53329-080-57 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 53329-080-58 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 53329-080-58 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 53329-080-57 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 53329-080-57 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 53329-080-58 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 53329-080-58 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 53329-080-57 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 53329-080-57 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 53329-080-58 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 53329-080-58 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 53329-080-57 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 53329-080-57 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 53329-080-58 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 53329-080-57 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 53329-080-58 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 53329-080-57 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 53329-080-58 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 53329-080-57 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 53329-080-58 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 53329-080-57 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 53329-080-58 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 53329-080-57 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 53329-080-58 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 53329-080-57 | 557ba5c1ecfa… | 9c80585c8c6e… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 53329-080-57 | GM - Gram | 53329-080 | dd3c27b5-d2dd-4678-b9ef-191b3976fd37 | 1 | 2012-07-24 |
| 53329-080-58 | GM - Gram | 53329-080 | 67d5c4bd-053a-418b-83a8-efdce3b4539b | 1 | 2012-07-24 |
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 |
|---|---|---|---|---|---|---|
| Meridian Unwrapped Antibacterial Deodorant | BENZETHONIUM CHLORIDE | Liufangjing Biotechnology (Yangzhou) Co., Ltd | 67d1d65a-71d4-41fc-a71c-85a28ce6de0c | 2025-06-18 | Warnings | M005 |
| Meridian Antibacterial Deodorant | BENZETHONIUM CHLORIDE | Liufangjing Biotechnology (Yangzhou) Co., Ltd | 640df217-6982-441e-835a-dbe2031e732b | 2025-06-18 | Warnings | M005 |
| EYELID WIPES | EYELID WIPES | Shenzhen Shierjie Biological Engineering Co., LTD | 377fb842-aa78-ab2a-e063-6394a90a69f9 | 2025-06-13 | Warnings | M005 |
| Lunavia Antifungal Foot Balm | ZINC UNDECYLENATE 10% | XF Agencija Limited | 466f3285-9800-4219-902f-b78a713b952f | 2025-06-13 | Warnings | M005 |
| Foot Cure Antifungal Foot Balm | ZINC UNDECYLENATE | Sansar LLC | ac6075bf-cc1d-4e8a-aa13-5a85e80f34ee | 2025-06-13 | Warnings | M005 |
| Lunavia Antifungal | UNDECYLENIC ACID 25% | XF Agencija Limited | 55891d2f-e2b8-4d9f-8140-dc258926ed90 | 2025-06-13 | Warnings | M005 |
| TEGASOLVE TOENAIL FUNGUS TREATMENT | UNDECYLENIC ACID 25% | Zhengzhou Hangrui Network Technology Co., Ltd. | 375b0515-1b1f-23b8-e063-6294a90a9d68 | 2025-06-12 | Warnings | M005 |
| Miconazole Nitrate | ANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREE | CVS Pharmacy | 979ab1d2-f184-455d-b31a-2ff2bd4592b8 | 2025-06-12 | Warnings | M005 |
| Gemachlich ZuHause Fungal Nail Revitalizer | GEMACHLICH ZUHAUSE FUNGAL NAIL REVITALIZER | Guangdong Quadrant Ecological Technology Co., Ltd. | 37332cdf-7171-42cc-e063-6394a90a0fcf | 2025-06-10 | Warnings | M005 |
| Eyelid Wipes | EYELID WIPES | Shenzhen Shierjie Biological Engineering Co., LTD | 36ddfa37-3913-9e48-e063-6294a90ae1be | 2025-06-08 | Warnings | M005 |
| Everywhere Flushable Wipes | EVERYWHERE FLUSHABLE WIPES | Shenzhen Shierjie Biological Engineering Co., LTD | 371be299-5aaf-b9d7-e063-6294a90a87f5 | 2025-06-08 | Warnings | M005 |
| Fungus Master | MICONAZOLE NITRATE | Clinical Resolution Laboratory, Inc. | 36eb334e-246b-249f-e063-6294a90ab811 | 2025-06-06 | Warnings | M005 |
| Miconazole Nitrate | ANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREE | Hudson Health LLC | 8d725a50-fbe4-4a48-9cbf-f8b5c12dd647 | 2025-06-03 | Warnings | M005 |
| CharmTex Lightly Scented Antibacterial | BENZETHONIUM CHLORIDE | Liufangjing Biotechnology (Yangzhou) Co., Ltd | 1c9f4bff-3f6f-4498-b8a2-7d7f49d6ad2d | 2025-06-01 | Warnings | M005 |
| DermaD ANTIFUNGAL Therapeutic | SALICYLIC ACID | Chen Cohen Industries Inc. | b97684ae-79d0-4208-b480-67794596ece7 | 2025-05-29 | Warnings | M005 |
| Fungazol Athlete Foot | MICONAZOLE NITRATE | Rida LLC | ce60e1ec-a69b-4b98-a2b2-105e9cd37bc7 | 2025-05-28 | Warnings | M005 |
| Antifungal Boday Wash | TOLNAFTATE | CAVTECH HOLDING LLC | 3619d717-fe42-412f-e063-6394a90a0384 | 2025-05-27 | Warnings | M005 |
| Toenail Fungus Liquid | TOENAIL FUNGUS LIQUID | Shenzhen Earth Surface Trading Co., Ltd. | 361f4c5c-7fa7-0440-e063-6294a90aad9f | 2025-05-27 | Warnings | M005 |
| help it Antiseptic | BENZALKONIUM CHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | 0b22f423-eb11-445f-a484-9326c1fe3ad5 | 2025-05-27 | Warnings | M005 |
| Seacall Hydrocortisone Ointment. | SEACALL HYDROCORTISONE OINTMENT | Guangdong Quadrant Ecological Technology Co., Ltd. | 3616980a-03dc-deba-e063-6394a90a6ce7 | 2025-05-26 | Warnings | M005 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53329-080-57 | 53329008057 | 141 g in 1 TUBE (53329-080-57) | 141 g | 2007-01-01 | 0000-00-00 | No | No | Current |
| 53329-080-58 | 53329008058 | 56 g in 1 TUBE (53329-080-58) | 56 g | 2007-01-01 | 0000-00-00 | No | No | Current |