Soothe And Cool Treat
- Product NDC
- 53329-080
- Requested package NDC
- 53329-080-57
- 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 | 53329-080-57 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 53329-080 | 53329-080-57 | D | Discontinued by firm | 2026-10-12 |
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 |
|---|---|---|---|---|---|---|
| EXTRA STRENGTH TOENAIIL RENEWAL PEN | UNDECYLENIC ACID, TOLNAFTATE | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 4eea5ee7-0ef9-8d34-e063-6294a90af595 | 2026-04-07 | Warnings | M005 |
| EXTRA STRENGTH TOENAIIL RENEWAL Solution | UNDECYLENIC ACID, TOLNAFTATE | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 4eeaa2f0-efc7-eab3-e063-6294a90a13b3 | 2026-04-07 | Warnings | M005 |
| Extra Strength Toenail Renewal Pen | UNDECYLENIC ACID, TOLNAFTATE | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 4eeb59d2-3891-2e45-e063-6294a90a4fcf | 2026-04-07 | Warnings | M005 |
| RoyceDerm Tinea ANTIFUNGAL .soap. | CLOTRIMAZOLE 1% | RoyceDerm LLC | 4e889f2b-9ea1-b1a6-e063-6394a90a4654 | 2026-04-03 | Warnings | M005 |
| Toenail Fungus Treatment Extra Strength Pen | TOLNAFTATE, UNDECYLENIC ACID | Lianjiang Shanlilai E-commerce Co., Ltd. | 28fbcc50-a3ac-d6d1-e063-6294a90aa2b6 | 2026-04-02 | Warnings | M005 |
| TOENAIL FUNGUS TREATMENT Liquid | TOLNAFTATE, UNDECYLENIC ACID | Lianjiang Shanlilai E-commerce Co., Ltd. | 28fc7049-e367-42bf-e063-6394a90a6f06 | 2026-04-02 | Warnings | M005 |
| Fungal Nail Patches | TOLNAFTATE, UNDECYLENIC ACID | Lianjiang Shanlilai E-commerce Co., Ltd. | 299a63ad-f321-117c-e063-6394a90a3a22 | 2026-04-02 | Warnings | M005 |
| Secura Antifungal Greaseless | MICONAZOLE NITRATE | Smith & Nephew Medical Ltd | 9be600e4-76ec-4071-a8ec-a0b23155271d | 2026-04-02 | Warnings | M005 |
| FifthPulse Bacitracin Zinc | BACITRACIN ZINC | WeCare Products LLC | 5c6b3ad8-c158-4cc0-b1ba-b829b5df1284 | 2026-04-02 | Warnings | M005 |
| FifthPulse Miconazole Nitrate Antifungal | MICONAZOLE NITRATE | WeCare Products LLC | b70238eb-afcb-4e09-976f-973df249241c | 2026-04-02 | Warnings | M005 |
| ANTIFUNGAL PEN | UNDECYLENIC ACID, TERBINAFINE HYDROCHLORIDE | Hanyang Qisheng (Shenzhen) Technology Co., Ltd. | 4e85f338-ffd7-85b1-e063-6294a90a3c87 | 2026-04-02 | Warnings | M005 |
| RoyceDerm Anti-Fungal Cream | MICONAZOLE NITRATE 2% | RoyceDerm LLC | 4e861073-88e8-b2f7-e063-6394a90ab94a | 2026-04-02 | Warnings | M005 |
| Miconazole Nitrate | JOCK ITCH SPRAY | CVS Pharmacy | 7b70d3ea-126a-42aa-8509-b982893c710b | 2026-04-01 | Warnings | M005 |
| Fungicure Anti-Fungal Liquid | TOLNAFTATE | Kobayashi Healthcare International, Inc. | b18ee199-0659-733c-e053-2a95a90ab6b5 | 2026-04-01 | Warnings | M005 |
| Tolnaftate | ANTIFUNGAL LIQUID SPRAY | CVS Pharmacy | 96cc594d-85c8-4f62-bc0a-3176c8739f21 | 2026-04-01 | Warnings | M005 |
| Tolnafate | TOLNAFTATE POWDER SPRAY | CVS Pharmacy | a7b6bd7c-23db-43e1-92f7-e27f5f4801de | 2026-04-01 | Warnings | M005 |
| Baza Antifungal | MICONAZOLE NITRATE | Coloplast Corp | 75182cb7-840a-423a-9c20-10840d6e1d65 | 2026-03-31 | Warnings | M005 |
| MICONAZOLE Nitrate 2% Cream ANTIFUNGAL | MICONAZOLE NITRATE | Trifecta Pharmaceuticals Usa Llc | 80217dbb-a0f0-414a-8d22-a9a346b017aa | 2026-03-31 | Warnings | M005 |
| RoyceDerm Antifungal Bar | CLOTRIMAZOLE | RoyceDerm LLC | 3abdc4a8-58dd-5bd0-e063-6294a90a1bca | 2026-03-31 | Warnings | M005 |
| Critic Aid Clear AF | MICONAZOLE NITRATE | Coloplast Corp | cbc5d976-850a-476e-b179-b7a5a8675524 | 2026-03-31 | 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 |