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 | 2026-10-12 | |
| excluded package | package | 53329-080 | 53329-080-58 | 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 |
|---|---|---|---|---|---|---|
| PHARMBANNER TINEA VERSICOLOR Cream | TINEA VERSICOLOR CREAM | Shenzhen Xinxin Yunhai Technology Co., Ltd. | 3db832f4-630d-72a2-e063-6394a90a08dc | 2026-02-12 | Warnings | M005 |
| Tolnafate | TOLNAFTATE JOCK ITCH POWDER SPRAY - TALC FREE | Chain Drug Consortium, LLC | 5f9edcf9-b99e-65a2-e053-2a91aa0af565 | 2026-02-12 | Warnings | M005 |
| Tolnafate | TOLNAFTATE POWDER SPRAY | Chain Drug Consortium, LLC | 5fafc16d-7257-fc88-e053-2991aa0a67c4 | 2026-02-12 | Warnings | M005 |
| Kerova Miconazole Nitrate | MICONAZOLE NITRATE | Guangzhou Bixiaoyu Trading Co., Ltd. | 3b8b5547-f8d1-9e48-e063-6294a90af429 | 2026-02-12 | Warnings | M005 |
| natouch | MICONAZOLE | Natouch LLC | a980ff33-2b6d-3065-e053-2995a90ae974 | 2026-02-11 | Warnings | M005 |
| Tuymec Antifungal Medicated Bar | ANTIFUNGAL MEDICATED BAR | Guangzhou Jingliang Cosmetics Co., Ltd. | 4a8265c5-9c69-a36a-e063-6294a90ab292 | 2026-02-11 | Warnings | M005 |
| Tuymec FUNGAL NAIL TREATMENT Kit | FUNGAL NAIL TREATMENT KIT | Guangzhou Jingliang Cosmetics Co., Ltd. | 4a983b42-9723-7a3a-e063-6394a90ae7b2 | 2026-02-11 | Warnings | M005 |
| Miconazole Nitrate | ATHLETES FOOT SPRAY | CVS Pharmacy | 1f5e3bfb-b6b9-4b22-9c34-71112bcf0c3c | 2026-02-10 | Warnings | M005 |
| Kerova ANTIFUNGAL | CLOTRIMAZOLE | Guangzhou Bixiaoyu Trading Co., Ltd. | 4a7b48cf-72c3-be63-e063-6394a90a1efe | 2026-02-10 | Warnings | M005 |
| Kerova Clotrimazole | ANTIFUNGAL | Guangzhou Bixiaoyu Trading Co., Ltd. | 4a7b9658-f411-299d-e063-6394a90af9ce | 2026-02-10 | Warnings | M005 |
| natouch | MICONAZOLE | Natouch LLC | 3b1209fc-9d6b-2f55-e063-6394a90ac2ad | 2026-02-10 | Warnings | M005 |
| Nabrace Wipes for Ringworm, Jockitch and Athlete Feet | NABRACE WIPES FOR RINGWORM, JOCKITCH AND ATHLETE FEET | Nabrace LLC | 0fdd1658-5759-8a42-e063-6394a90a7271 | 2026-02-10 | Warnings | M005 |
| APUREE Nailtific Extra-Max Strength Antigungal | APUREE NAILTIFIC EXTRA-MAX STRENGTH ANTIGUNGAL | Guangzhou Meixi Biotechnology Co., Ltd. | 4a633da8-dcba-349c-e063-6294a90a7702 | 2026-02-09 | Warnings | M005 |
| Fungus Master Antifungal Treatment | MICONAZOLE NITRATE | Ebanel Laboratories, Inc | f7b011b2-11e5-46f1-afed-89f438985e00 | 2026-02-09 | Warnings | M005 |
| OSIMOON Toenail Fungus Treatment | TOENAIL FUNGUS TREATMENT | Guangzhou Jingliang Cosmetics Co., Ltd. | 4a7061a9-8ba2-72b8-e063-6294a90a4d9a | 2026-02-09 | Warnings | M005 |
| CLOTRIMAZOLE 1% | CLOTRIMAZOLE | PHARMACY CHOICE INC | 43852cfb-6d28-e54f-e063-6394a90aa090 | 2026-02-08 | Warnings | M005 |
| ASSIELF ANTIFUNGAL PEN | UNDECYLENIC ACID | Shenzhen Yuanbang International Logistics Co., Ltd | 4a5d8e86-6401-7556-e063-6394a90acce1 | 2026-02-08 | Warnings | M005 |
| Dryello Dual Action Relief for Athlete Foot | TOLNAFTATE | ProPedix, Inc. | 359478dd-02c9-05e5-e063-6294a90a41ed | 2026-02-06 | Warnings | M005 |
| HEALMUSZ Clotrimazole | CLOTRIMAZOLE1% MICONAZOLE1% CLOTRIMAZOLE | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a326159-a6a7-c1d6-e063-6294a90a3b89 | 2026-02-06 | Warnings | M005 |
| Antifungal Liquid | TOLNAFTATE | Wal-Mart Stores, Inc. | 17d0486e-e8b5-3afe-e063-6394a90aa384 | 2026-02-04 | 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 |