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 | 2026-10-05 | |
| 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 | 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 |
|---|---|---|---|---|---|---|
| WISH HAND SANITIZER Strawberry Musk | ALCOHOL HAND SANITIZER | PT SUPER HOME PRODUCT INDONESIA | 59143edb-41fe-0a1f-e063-6394a90a81a5 | 2026-08-15 | Warnings | M005 |
| WISH HAND SANITIZER Rose Woods | ALCOHOL HAND SANITIZER | PT SUPER HOME PRODUCT INDONESIA | 58fb4491-2918-c486-e063-6394a90a621f | 2026-08-14 | Warnings | M005 |
| VXGXO antifungal with tea tree oil | TOLNAFTATE | Guangdong Aimu Biological Technology Co., Ltd | 58fd67c5-c985-13a7-e063-6294a90a40fb | 2026-08-14 | Warnings | M005 |
| Charmpoo ANTIFUNGAL BODY Cream | MICONAZOLE NITRATE 2% ANTIFUNGAL BODY CREAM | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 58ff4779-83a7-afe2-e063-6294a90a9f9a | 2026-08-14 | Warnings | M005 |
| TEATREEOILANTIFUNGAL | UNDECYLENIC ACID AND ZINC UNDECYLENATE | Foshan Chancheng District Xuntou Electronic Commerce Co., Ltd | 5900904f-cf51-4398-e063-6394a90aca6c | 2026-08-14 | Warnings | M005 |
| Clotrimazole | CLOTRIMAZOLE | YYBA CORP | 58f1707a-579b-1e06-e063-6294a90a5a9f | 2026-08-13 | Warnings | M005 |
| WISH HAND SANITIZER Mango Coconut Cream | ALCOHOL HAND SANITIZER | PT SUPER HOME PRODUCT INDONESIA | 58faa781-520b-92fa-e063-6294a90a9ecf | 2026-08-13 | Warnings | M005 |
| Gemachlich Zu Hause Vaginal Antifungal Gel | MICONAZOLE NITRATE | Guangzhou Xinhongda Trading Service Co., Ltd. | 563cfb57-f10c-96a6-e063-6294a90a2b93 | 2026-08-12 | Warnings | M005 |
| Hecila ANTIFUNGAL NAIL | UNDECYLENIC ACID 25% ANTIFUNGAL NAIL | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 58c117cc-e039-86f6-e063-6394a90af18f | 2026-08-12 | Warnings | M005 |
| TOTCLEAR NAIL RENEWAL | UNDECYLENIC ACID | GOOD BRIDGE LLC | 93605e22-920d-43c3-bb2b-6e3116a19f5e | 2026-08-12 | Warnings | M005 |
| TOTCLEAR NAIL RENEWAL | UNDECYLENIC ACID | GOOD BRIDGE LLC | fde7d6ea-1b44-4a88-820a-0f2e033727e1 | 2026-08-11 | Warnings | M005 |
| XBOFPEN MULTI-PURPOSE TREATMENT | TOLNAFTATE 1% MULTI-PURPOSE TREATMENT | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 58c2f50c-9c9e-4989-e063-6394a90abb21 | 2026-08-11 | Warnings | M005 |
| RoyceDerm Athletes foot antifungal .cream. | MICONAZOLE NITRATE 2% | RoyceDerm LLC | 58d23aa0-497e-4ece-e063-6294a90aef66 | 2026-08-11 | Warnings | M005 |
| QualiLife persimmon foot and shoe | UNDECYLENIC ACID | Guangdong Aimu Biological Technology Co., Ltd | 584966c7-ceae-91af-e063-6294a90ac1eb | 2026-08-10 | Warnings | M005 |
| Persiancat ANTIFUNGAL PEN | UNDECYLENIC ACID | Guangzhou ChuanMa International Trading Co.,Ltd. | 58affb96-6cfc-b1fb-e063-6294a90a340c | 2026-08-10 | Warnings | M005 |
| Dryello Tolnaftate 1% Antifungal | TOLNAFTATE | ProPedix, Inc. | 58b6820c-f601-5921-e063-6294a90aa5e9 | 2026-08-10 | Warnings | M005 |
| Medline | MICONAZOLE NITRATE | Medline Industries, LP | 3c43ef91-bbd2-5e58-e063-6294a90a00d3 | 2026-08-05 | Warnings | M005 |
| Antifungal Liquid | TOLNAFTATE | Family Dollar Services, Inc | 57c20748-fdad-b73b-e063-6294a90a1c17 | 2026-08-04 | Warnings | M005 |
| Lyssera Fungal Nail Renewal | UNDECYLENIC ACID 25% FUNGAL NAIL RENEWAL | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 5843c1a0-ab60-bd64-e063-6294a90af858 | 2026-08-04 | Warnings | M005 |
| YAMANGU FUNGAL NAIL RENEWAL | UNDECYLENIC ACID 25% FUNGAL NAIL RENEWAL | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 5843cc12-de66-ca47-e063-6294a90ae55b | 2026-08-04 | 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 |