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 |
|---|---|---|---|---|---|---|
| Miconazole Nitrate | ATHLETES FOOT POWDER SPRAY TALC FREE | Wal-Mart Stores, Inc | af4d4e9e-8678-3a80-e053-2995a90a677f | 2026-04-22 | Warnings | M005 |
| Tolnaftate | ANTIFUNGAL LIQUID SPRAY | Wal-Mart Stores, Inc | af4ebb3b-041e-30dd-e053-2995a90a8d2d | 2026-04-22 | Warnings | M005 |
| Tolnafate | TOLNAFTATE POWDER SPRAY | Wal-Mart Stores, Inc | af4dd045-ca51-42b9-e053-2a95a90a0327 | 2026-04-22 | Warnings | M005 |
| 4oz | MICONAZOLE | Nabrace LLC | 4f912a20-e0f7-23c1-e063-6294a90a55d6 | 2026-04-18 | Warnings | M005 |
| Nabrace Wipes for Ringworm, Jockitch and Athlete Feet | NABRACE WIPES FOR RINGWORM, JOCKITCH AND ATHLETE FEET | Nabrace LLC | 4fc3ddc8-08a2-ae50-e063-6294a90a1e07 | 2026-04-18 | Warnings | M005 |
| SimplyVital Antifungal Clotrimazole | CLOTRIMAZOLE | Alpha Plants Inc | 44881106-3ab4-4103-9c48-1da435ab5b13 | 2026-04-16 | Warnings | M005 |
| medicated | MICONAZOLE | Nabrace LLC | 4f90d8ad-33d9-0043-e063-6394a90a4466 | 2026-04-16 | Warnings | M005 |
| Ingrown Nail Treatment | JALAWEF INGROWN NAIL TREATMENT | Consilii LLC | 1ac2d7fc-1806-7925-e063-6294a90ad3b5 | 2026-04-15 | Warnings | M005 |
| RDVHDLW Extra Strength NAIL REPAIR PEN | TOLNAFTATE, UNDECYLENIC ACID | Shenzhen Joyuflsh Technology Co.,Ltd. | 4f68796c-11e1-e5f7-e063-6394a90adeb1 | 2026-04-14 | Warnings | M005 |
| ProBliva Psoriasis Scalp .spray. | SALICYLIC ACID 3% | CAVTECH HOLDING LLC | 4f695604-51c5-c1b7-e063-6294a90ab5ae | 2026-04-14 | Warnings | M005 |
| OSIMOON Fungal Nail Treatment | FUNGAL NAIL TREATMENT | Guangzhou Jingliang Cosmetics Co., Ltd. | 4f7817db-cd71-fba9-e063-6294a90a9cdf | 2026-04-14 | Warnings | M005 |
| Quali Life ANTIFUNGAL PERSIMMON | TOLNAFTATE | Guangdong Aimu Biological Technology Co., Ltd | 4f520058-3b81-574e-e063-6294a90a2eae | 2026-04-13 | Warnings | M005 |
| Quali Life ANTIFUNGAL CHARCOAL | TOLNAFTATE | Guangdong Aimu Biological Technology Co., Ltd | 4f538041-e2f1-4a5f-e063-6294a90a54cf | 2026-04-13 | Warnings | M005 |
| RoyceDerm tinea ANTIFUNGAL .cream. and .soap. | CREAM AND SOAP | RoyceDerm LLC | 4f4ef2d0-98fa-e791-e063-6394a90a7045 | 2026-04-12 | Warnings | M005 |
| Nailtific Daytime Treatment Antifungal Pen Refill | NAILTIFIC DAYTIME TREATMENT ANTIFUNGAL PEN REFILL | Guangzhou Meixi Biotechnology Co., Ltd. | 4257ee32-0d8f-08d4-e063-6294a90a4a89 | 2026-04-11 | Warnings | M005 |
| Nailtific Nighttime Antifungal Renewal Pen Refill | TOLNAFTATE | Guangzhou Meixi Biotechnology Co., Ltd. | 42634fc7-d0c7-4813-e063-6294a90a702d | 2026-04-11 | Warnings | M005 |
| Maximum Strength Antifungal Liquid | TOLNAFTATE | Chain Drug Marketing Association Inc | 1a4f4d10-6782-ddb4-e063-6294a90ac206 | 2026-04-09 | Warnings | M005 |
| Extra Strength Toenail Renewal Solution | UNDECYLENIC ACID, TOLNAFTATE | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 4eed68e6-6814-0181-e063-6394a90a888e | 2026-04-08 | Warnings | M005 |
| TAGOQHIA Extra Strength NAIL REPAIR PEN | TOLNAFTATE, UNDECYLENIC ACID | Guangzhou Borderless Technology Co., Ltd. | 4eefbef4-7643-dca4-e063-6394a90a72c1 | 2026-04-08 | Warnings | M005 |
| ZYNTHIX | UNDECYLENIC ACID SOLUTION | Shenzhen Siwei Yijiu Trading Co., Ltd. | 4ef4a167-f673-efb4-e063-6294a90a3026 | 2026-04-08 | 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 |