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 |
|---|---|---|---|---|---|---|
| Lotrimin | CLOTRIMAZOLE | Bayer HealthCare LLC. | b584e17f-ed43-43bd-b643-dfa48edd78c6 | 2025-12-05 | Warnings | M005 |
| Fungicure Night Cream | CLOTRIMAZOLE | Kobayashi Healthcare International, Inc. | 43029403-2afd-cfa1-e063-6394a90a99a3 | 2025-12-04 | Warnings | M005 |
| Lotrimin Daily Prevention Deo | TOLNAFTATE | Bayer HealthCare LLC. | 9e8bfb78-ad81-93d0-e053-2995a90aa41d | 2025-12-04 | Warnings | M005 |
| Lotrimin AF Jock Itch | MICONAZOLE NITRATE | Bayer Healthcare LLC. | 0c53cf0f-767e-a422-e063-6394a90ab764 | 2025-12-04 | Warnings | M005 |
| Tinactin | TOLNAFTATE | Bayer HealthCare LLC. | 0a80a5b0-3216-46f6-8801-7066ef59aee4 | 2025-12-04 | Warnings | M005 |
| Lotrimin Antifungal | CLOTRIMAZOLE | Bayer HealthCare LLC. | f9536683-3f32-4c71-9b6a-70f8611e3dcf | 2025-12-04 | Warnings | M005 |
| Lotrimin AF Deodorant | MICONAZOLE NITRATE | Bayer HealthCare LLC. | 0bee54eb-df2f-15fe-e063-6294a90a2fd2 | 2025-12-04 | Warnings | M005 |
| Tinactin | TOLNAFTATE | Bayer HealthCare LLC. | 0beda157-efd2-5245-e063-6394a90a6911 | 2025-12-04 | Warnings | M005 |
| Lotrimin AF | MICONAZOLE NITRATE | Bayer Healthcare LLC. | 163996c6-af54-21ac-e063-6394a90ac05c | 2025-12-04 | Warnings | M005 |
| Lotrimin Daily Prevent Deodorant | TOLNAFTATE | Bayer HealthCare LLC. | 1bb961cd-b6e6-3aff-e063-6394a90a432e | 2025-12-04 | Warnings | M005 |
| Tinactin Deodorant | TOLNAFTATE | Bayer HealthCare LLC. | 1751d576-e94a-d7d1-e063-6294a90a03ff | 2025-12-04 | Warnings | M005 |
| Tinactin Jock Itch | TOLNAFTATE | Bayer HealthCare LLC | 163ab4df-6e4a-6239-e063-6294a90a1cd0 | 2025-12-04 | Warnings | M005 |
| Tinactin | TOLNAFTATE | Bayer HealthCare LLC | bb878f31-2189-4427-aacf-5bce96d75978 | 2025-12-04 | Warnings | M005 |
| Lotrimin | CLOTRIMAZOLE | Bayer HealthCare LLC | da948ef3-3709-4bfc-9d17-f6f1ea325343 | 2025-12-04 | Warnings | M005 |
| Myco Nail A Antifungal Solution | UNDECYLENIC ACID | Kramer Novis | 550358d7-69e8-4ea3-bcf9-d647c457287d | 2025-12-04 | Warnings | M005 |
| Tea Tree Oil Antifungal Soaps | TOLNAFTATE | Nanjing Jitaxing Technology Co., LTD | 4517d3a7-9144-b91d-e063-6294a90a4990 | 2025-12-03 | Warnings | M005 |
| Miconazole Nitrate | MICONAZOLE NITRATE | A-S Medication Solutions | 23ca78c0-16a9-455c-99a7-b9a9a3affa60 | 2025-12-03 | Warnings | M005 |
| Gembooxt Nail Fungus Solution | GEMBOOXT NAIL FUNGUS SOLUTION | Guangdong Quadrant Ecological Technology Co., Ltd. | 44f5c1bc-decf-beef-e063-6394a90ab562 | 2025-12-02 | Warnings | M005 |
| WELMATE Clotrimazole Topical Solution | CLOTRIMAZOLE | YYBA CORP | dc5bac4a-938c-4678-89ac-a899440c6a3c | 2025-12-02 | Warnings | M005 |
| Tolnaftate Cream 1% ANTIFUNGAL | TOLNAFTATE | CARDINAL HEALTH 110 dba LEADER | bb14825c-518d-bfba-e053-2995a90a7889 | 2025-12-02 | 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 |