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 | 2026-10-15 | |
| excluded package | package | 53329-080 | 53329-080-57 | D | Discontinued by firm | 2026-10-15 |
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 |
|---|---|---|---|---|---|---|
| FIRST SHIELD | BENZALKONIUM CHLORIDE, LIDOCAINE HCI | Ever Ready First Aid | ee198aa1-ad0d-9185-e053-2a95a90a6595 | 2024-01-15 | Warnings | M005 |
| Ever Ready HAND SANITIZER | ETHYL ALCOHOL | Ever Ready First Aid | ec1af7ef-3c95-9c60-e053-2a95a90acf47 | 2024-01-15 | Warnings | M005 |
| MY MEDIC SUPER SANITIZER | ETHYL ALCOHOL | Sled Distribution, LLC | e7451738-75d5-5dc4-e053-2a95a90a7aee | 2024-01-15 | Warnings | M005 |
| Medical Super | ALCOHOL | Beijing HKKY Medical Tech. Co., Ltd. | ed2649c6-d971-4338-8745-cd0a40f7b0c2 | 2024-01-13 | Warnings | M005 |
| ER Hand Sanitizer Packets | ALCOHOL | EVER READY FIRST AID | d0b6d09c-26e0-45c7-8d37-7d42143b2e31 | 2024-01-11 | Warnings | M005 |
| clotrimazole | CLOTRIMAZOLE | Proficient Rx LP | eeb241a3-93ee-4b74-8cbb-65713d15e7e0 | 2024-01-01 | Warnings | M005 |
| Clotrimazole | CLOTRIMAZOLE | Proficient Rx LP | ba1dc4a4-073f-4f30-bb9c-9ed043700431 | 2024-01-01 | Warnings | M005 |
| RUGBY ANTIFUNGAL CLOTRIMAZOLE | CLOTRIMAZOLE | Proficient Rx LP | 7c64553b-589c-4e65-a6f0-b2847bbbe8a6 | 2024-01-01 | Warnings | M005 |
| Dr. Scholls Instant Cool Athletes foot treatment with Menthol | TOLNAFTATE | Scholl's Wellness Company | dad00745-e411-35b8-e053-2a95a90a1000 | 2023-12-21 | Warnings | M005 |
| TINEACIDE | TOLNAFTATE | Blaine Labs Inc. | 273eb424-5dc3-40c8-9ea7-2f732cbd11c9 | 2023-12-21 | Warnings | M005 |
| TERPENICOL ANTIFUNGAL | UNDECYLENIC ACID | Blaine Labs Inc. | a020334e-aac9-4ea5-a0ea-8e5b021fe2eb | 2023-12-21 | Warnings | M005 |
| TERPENICOL | UNDECYLENIC ACID | Blaine Labs Inc. | efd99ed1-07d3-4862-ae47-883f7d1c91c6 | 2023-12-21 | Warnings | M005 |
| sunmark antifungal | TOLNAFTATE | A-S Medication Solutions | 6f85fbb0-297c-4949-83f2-ed9a52172154 | 2023-12-16 | Warnings | M005 |
| Miconazole Nitrate | MICONAZOLE NITRATE | A-S Medication Solutions | 7a0ef38a-9584-4e67-ba86-c31f86da1ed0 | 2023-12-11 | Warnings | M005 |
| Miconazole Nitrate | MICONAZOLE NITRATE | A-S Medication Solutions | 7d284f6f-a970-49fe-b45a-d5c6c2688bc2 | 2023-12-11 | Warnings | M005 |
| Hi Vetic | TOLNAFTATE | Sato Pharmaceutical Co., Ltd. | 2096e241-3ed3-49cd-88c4-71db1fd2934a | 2023-12-06 | Warnings | M005 |
| Undecylenic Acid | UNDECYLENIC ACID | Chemco Corporation | 7391b53f-5567-1f45-e053-2991aa0a4fce | 2023-12-05 | Warnings | M005 |
| Hi Vetic | TOLNAFTATE | Sato Pharmaceutical Co., Ltd. | be92b480-56e8-4371-adbc-40fe74f6747c | 2023-12-01 | Warnings | M005 |
| Antifungal Cream | ANTIFUNGAL | BluePoint Laboratories | b4c4240f-f84c-ec5e-e053-2a95a90aa082 | 2023-11-17 | Warnings | M005 |
| Antifungal Cream | ANTIFUNGAL | BluePoint Laboratories | b564f971-2a9b-a605-e053-2995a90aee69 | 2023-11-17 | 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 |