Soothe And Cool Treat
- Product NDC
- 53329-080
- Requested package NDC
- 53329-080-58
- 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 package | package | 53329-080 | 53329-080-58 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 53329-080 | 53329-080-58 | D | Discontinued by firm | 2026-10-15 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 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 |
|---|---|---|---|---|---|---|
| TopCare Antifungal Maximum Strength | UNDECYLENIC ACID | TOPCO ASSOCIATES LLC | 7c44fb4e-0eef-4ced-b03f-a02ebe6c0264 | 2025-12-22 | Warnings | M005 |
| Fungi Nail Toe and Foot | TOLNAFTATE | Kramer Laboratories | a3ae043b-dc97-449b-b099-70bdf8e92482 | 2025-12-19 | Warnings | M005 |
| Clotrimazole | CLOTRIMAZOLE | RUGBY LABORATORIES | 6de9155b-7070-38fd-e053-2a91aa0af6f6 | 2025-12-19 | Warnings | M005 |
| HC Max Anti-Fungal | TOLNAFTATE | Kramer Laboratories | ee99cd87-549f-4a43-878e-b4d5935de0e0 | 2025-12-19 | Warnings | M005 |
| Fungi Nail Anti-Fungal Pen | TOLNAFTATE | Kramer Laboratories | 1a0a3b14-d8f2-4363-b3c9-f5028e8eada3 | 2025-12-19 | Warnings | M005 |
| Tolnaftate | FOOT ODOR CONTROL POWDER SPRAY | Winco Foods, LLC | cc257a18-247f-c787-e053-2a95a90a075a | 2025-12-16 | Warnings | M005 |
| Tolnaftate | ODOR CONTROL POWDER SPRAY | Walgreen Company | a113f568-bd20-4f02-8e09-1b8223a0a9fa | 2025-12-16 | Warnings | M005 |
| Tobcharm Toenail Fungus Treatment Liquid | TOENAIL FUNGUS TREATMENT LIQUID | Guangzhou Qiexiran Cosmetics Co., Ltd. | 45f92be2-0677-5989-e063-6394a90af280 | 2025-12-15 | Warnings | M005 |
| TEA TREE Oil ANTIFUNGAL Cream | ZINC UNDECYLENATE, UNDECYLENIC ACID | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 45bd3ad0-a0d1-314f-e063-6394a90a9a3a | 2025-12-12 | Warnings | M005 |
| Miconazole Nitrate | ATHLETES FOOT POWDER SPRAY TALC FREE | Topco Associates LLC | 97334166-1dff-4ed2-ad31-f524b22097f9 | 2025-12-12 | Warnings | M005 |
| Foot Odor Control Powder | TOLNAFTATE | Meijer Distribution Inc | 03fd2680-0040-aa8c-e063-6294a90a090f | 2025-12-12 | Warnings | M005 |
| Foot Odor Control Powder | TOLNAFTATE | Premier Brands of America Inc. | edb0a2da-aaa1-3b9b-e053-2995a90a5012 | 2025-12-12 | Warnings | M005 |
| Pedikleer | TOLNAFTATE | Rising Pharma Holdings, Inc. | 83396c51-7107-4d98-9d80-ebf6584f4dc8 | 2025-12-11 | Warnings | M005 |
| ELAIMEI FUNGAL NAIL PATCHES | TEA TREE OIL | Shenzhen Shandian Jingling Technology Co., Ltd. | 457d08eb-e812-8f12-e063-6294a90ab85f | 2025-12-10 | Warnings | M005 |
| Lofuanna FUNGAL NAIL PATCHES | TEA TREE OIL | Shenzhen Shandian Jingling Technology Co., Ltd. | 43da9ec2-5f2f-dfce-e063-6394a90aecca | 2025-12-10 | Warnings | M005 |
| WRFAATGO ANTIFUNGAL Pen Undecylenic Acid 25% | UNDECYLENIC ACID 25% | Shenzhen Shandian Jingling Technology Co., Ltd. | 457f819b-0850-a97c-e063-6394a90ac368 | 2025-12-09 | Warnings | M005 |
| NAIL REPAIR PEN | UNDECYLENIC ACID | Yunqi Cosmetics (Shenzhen) Co., Ltd | 45814b84-0e51-6c9d-e063-6394a90a2905 | 2025-12-09 | Warnings | M005 |
| Miconazole Nitrate | MICONAZOLE NITRATE ANTIFUNGAL POWDER SPRAY | Better Living Brands | ccfef81b-f271-4551-e053-2a95a90a8ac4 | 2025-12-09 | Warnings | M005 |
| Miconazole Nitrate | ANTI-FUNGAL MICONAZOLE ATHLETES FOOT SPRAY TALC FREE | Foodhold USA | a64c9371-0ac7-4c47-bc12-7bc77162b244 | 2025-12-09 | Warnings | M005 |
| Miconazole Nitrate | ATHLETES FOOT POWDER SPRAY TALC FREE | Harris Teeter, LLC | 02eb9c78-5a89-4958-b5a4-68f39e584cf2 | 2025-12-09 | Warnings | M005 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53329-080-58 | 53329008058 | 56 g in 1 TUBE (53329-080-58) | 56 g | 2007-01-01 | 0000-00-00 | No | No | Current |