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 |
|---|---|---|---|---|---|---|
| SSPROTIP X Extra Strength Nail Renewal Patches | TOLNAFTATE | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 52512e7e-5e28-4383-e063-6294a90a448a | 2026-05-21 | Warnings | M005 |
| Vrenmol Extra Strength Nail Renewal Patches | TOLNAFTATE | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 52516861-e386-d0cb-e063-6394a90a17d0 | 2026-05-21 | Warnings | M005 |
| SSPROTIP X Extra Strength Toenail Renewal Solution | TOLNAFTATE,UNDECYLENIC ACID | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 52519110-a3c9-21da-e063-6294a90abbce | 2026-05-21 | Warnings | M005 |
| NERANTE Antifungal Cream | MICONAZOLE NITRATE, HYDROCORTISONE | Guangzhou Xinhongda Trading Service Co., Ltd. | 52281e10-59db-1d1c-e063-6394a90aadfe | 2026-05-21 | Warnings | M005 |
| Fungal Nail Repair Pen | UNDECYLENIC ACID | Yunqi Cosmetics (Shenzhen) Co., Ltd | 523c32f7-b803-bf79-e063-6394a90aad5a | 2026-05-20 | Warnings | M005 |
| Medi-First Clotrimazole 1% ANTIFUNGAL Cream | CLOTRIMAZOLE | Unifirst First Aid Corporation | 522eeb91-8378-32f4-e063-6394a90aff43 | 2026-05-20 | Warnings | M005 |
| Kopa Haiku Antifungal Cream | MICONAZOLE NITRATE 2% | Trovina Co. Ltd | 47cf1251-5965-045a-e063-6394a90ab04f | 2026-05-19 | Warnings | M005 |
| APUREE PRO Nailtific Maximum Strength Antifungal Patches | APUREE PRO NAILTIFIC MAXIMUM STRENGTH ANTIFUNGAL PATCHES | Guangzhou Meixi Biotechnology Co., Ltd. | 5218bd5d-53b4-107f-e063-6394a90ae769 | 2026-05-18 | M005 | |
| APUREE Pro Nailtific Maximum Strength Dual-Action Antifungal Pen | APUREE PRO NAILTIFIC MAXIMUM STRENGTH DUAL-ACTION ANTIFUNGAL PEN | Guangzhou Meixi Biotechnology Co., Ltd. | 521a0e40-a218-fabb-e063-6294a90ae9a2 | 2026-05-18 | Warnings | M005 |
| Beukow Antifungal Pen | UNDECYLENIC ACID 25% ANTIFUNGAL PEN | Jiangxi Yudexi Pharmaceutical Co., LTD | 511d1edf-dfda-477c-e063-6294a90aa423 | 2026-05-17 | Warnings | M005 |
| Nail Repair Pen | NAIL REPAIR PEN | Shenzhen Earth Surface Trading Co., Ltd. | 520f6514-6660-d6a8-e063-6394a90adf82 | 2026-05-17 | Warnings | M005 |
| Fungicure Intensive | CLOTRIMAZOLE | Kobayashi Healthcare International, Inc. | 1f1b413f-278e-434f-8590-4cf731663f5c | 2026-05-15 | Warnings | M005 |
| Dr Scholls Fungal Nail Clear and Cure Tolnaftate Antifungal | TOLNAFTATE | Scholl's Wellness Company LLC | 8abd6d8e-c69e-4374-ace8-d42b2d3e171e | 2026-05-14 | Warnings | M005 |
| Dr.Scholl s Odor X Athlete s Foot | TOLNAFTATE | Scholl's Wellness Company LLC | 0e864882-5e00-491e-a008-0762c131637a | 2026-05-14 | Warnings | M005 |
| Athletes Foot | TOLNAFTATE | Rugby Laboratories | 50c46cf5-3e64-9e0f-e063-6294a90a2317 | 2026-05-14 | Warnings | M005 |
| TOSSOYA Rainforest SecretGuard Antibacterial Quick-Cleanse Wipes | TOSSOYA RAINFOREST SECRETGUARD ANTIBACTERIAL QUICK-CLEANSE WIPES | Shenzhen Shierjie Biological Engineering Co., LTD | 3d53463d-8d8e-9030-e063-6294a90ab454 | 2026-05-13 | Warnings | M005 |
| Anti-Fungal Powder | MICONAZOLE NITRATE | CVS Pharmacy | 1651bdd7-ab15-7a2d-e063-6294a90a8b91 | 2026-05-11 | Warnings | M005 |
| Lightning X Hand Cleanser | ETHYL ALCOHOL | Nantong Health & Beyond Hygienic Products Inc. | 51861f1e-8961-e876-e063-6394a90a2fd0 | 2026-05-11 | Warnings | M005 |
| APUREE Nailtific Maximum Strength Antifungal Patches PRO | APUREE NAILTIFIC MAXIMUM STRENGTH ANTIFUNGAL PATCHES PRO | Guangzhou Meixi Biotechnology Co., Ltd | 5189ebc5-8ee5-1b2c-e063-6294a90af5c8 | 2026-05-11 | Warnings | M005 |
| APUREE Nailtific Maximum Strength Dual-Action Antifungal Pen Pro | APUREE NAILTIFIC MAXIMUM STRENGTH DUAL-ACTION ANTIFUNGAL PEN PRO | Guangzhou Meixi Biotechnology Co., Ltd. | 518abf2b-6ac8-ab9b-e063-6294a90ae693 | 2026-05-11 | 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 |