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 |
|---|---|---|---|---|---|---|
| Formula 7 - The Solution | TOLNAFTATE | The Tetra Corporation | 18619649-7f79-4b6e-8b7c-69d70365d557 | 2025-08-18 | Warnings | M005 |
| GlyCylic | SALICYLIC ACID | The Tetra Corporation | 501d3ba9-ba42-4c1c-983b-492adaee039d | 2025-08-18 | Warnings | M005 |
| SupreH Ringworm Treatment Balm | SUPREH RINGWORM TREATMENT BALM | Shenzhen Xinxin Yunhai Technology Co., Ltd. | 3c77222b-d92e-84b0-e063-6294a90aadd7 | 2025-08-16 | Warnings | M005 |
| OetMoe Antifungal Solution | OETMOE ANTIFUNGAL SOLUTION | Shenzhen Earth Surface Trading Co., Ltd. | 3c26d917-4186-6f02-e063-6394a90a99f6 | 2025-08-12 | Warnings | M005 |
| Cureforte Anti Fungal Foot Care | ANTI FUNGAL FOOT CARE DROPS | STEEL CITY HEALTH PRIVATE LIMITED | 39f762a6-9d0c-8ded-e063-6394a90a3659 | 2025-08-11 | Warnings | M005 |
| Derman Antifungal Powder Tolnaftate | TOLNAFTATE | Taisho Pharmaceutical California Inc. | 3a854765-740c-4719-8abf-4b3f932cdee0 | 2025-08-07 | Warnings | M005 |
| Derman antifungal cream | TOLNAFTATE | Taisho Pharmaceutical California Inc. | 15d9b3c9-01af-4083-a1bc-014505d8798d | 2025-08-07 | Warnings | M005 |
| Maximum Strength Antifungal Liquid | TOLNAFTATE | Hudson Health LLC | 24b22794-f9f8-6f32-e063-6394a90aec98 | 2025-08-07 | Warnings | M005 |
| Toe Area Treatment | TOLNAFTATE | CVS | 17681cc8-fbb1-a0cf-e063-6294a90add18 | 2025-08-07 | Warnings | M005 |
| Antifungal Liquid | TOLNAFTATE | Family Dollar Services, Inc | 178e7b3f-949f-3f51-e063-6294a90a9395 | 2025-08-07 | Warnings | M005 |
| Antifungal Liquid | TOLNAFTATE | LEADER/Cardinal Health 110, Inc. | 17695563-3765-74cb-e063-6294a90a6120 | 2025-08-07 | Warnings | M005 |
| Antifungal Liquid | TOLNAFTATE | Target Corporation | 1dff278f-47bc-459a-e063-6394a90a2646 | 2025-08-07 | Warnings | M005 |
| Antifungal Liquid | TOLNAFTATE | TopCo Associates | 19c268a1-7b2e-63c9-e063-6394a90acddc | 2025-08-07 | Warnings | M005 |
| Antifungal Liquid Maximum Strength | TOLNAFTATE | Walgreens Company | 137eabb7-cb4f-1631-e063-6294a90ab847 | 2025-08-07 | Warnings | M005 |
| WCTNGO Fungal Nail Treatment Swabs | TOLNAFTATE,UNDECYLENIC ACID | Shenzhen Boyimei Technology Co., Ltd. | 3bad0d73-b33d-b962-e063-6294a90a7ba7 | 2025-08-06 | Warnings | M005 |
| ONIADBA Nail Fungus Treatment Pen | TOLNAFTATE,UNDECYLENIC ACID | Shenzhen Boyimei Technology Co., Ltd. | 3bad19f1-d5b3-c5de-e063-6294a90a0c03 | 2025-08-06 | Warnings | M005 |
| Antifungal Liquid | TOLNAFTATE | Premier Brands of America Inc | 2644ba07-aaee-6402-e063-6394a90a2827 | 2025-08-06 | Warnings | M005 |
| Anti- Fungal Miconazole Nitrate | MICONAZOLE NITRATE | Premier Brands of America Inc. | f186bdc1-db6c-0fab-e053-2995a90a7c58 | 2025-08-06 | Warnings | M005 |
| ONIADBA Fungal Nail Treatment Swabs | TOLNAFTATE,UNDECYLENIC ACID | Shenzhen Boyimei Technology Co., Ltd. | 3baa99ab-6d22-8d7d-e063-6294a90af3e8 | 2025-08-05 | Warnings | M005 |
| MICONAZOLE Nitrate 2% Cream ANTIFUNGAL | MICONAZOLE NITRATE | Preferred Pharmaceuticals Inc. | cca84334-2e2d-4991-9d1e-d5b7c9ffd392 | 2025-08-01 | 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 |