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 |
|---|---|---|---|---|---|---|
| ProClearz Maximum Strength Fungal Shield Brush-on Antifungal | TOLNAFTATE | Rooftop Consumer Health, Inc. | 4d451e87-c25b-49cf-92b8-747b053930c2 | 2026-03-02 | Warnings | M005 |
| HAND SANITIZER lsland Coconut | ALCOHOL HAND SANITIZER | PT SUPER HOME PRODUCT INDONESIA | 4bf3a822-27d2-efef-e063-6294a90a0502 | 2026-03-01 | Warnings | M005 |
| HAND SANITIZER Cherry Blossom | ALCOHOL HAND SANITIZER | PT SUPER HOME PRODUCT INDONESIA | 4bf48a93-345d-b901-e063-6394a90ab41b | 2026-03-01 | Warnings | M005 |
| HAND SANITIZER Cucumber Melon | ALCOHOL HAND SANITIZER | PT SUPER HOME PRODUCT INDONESIA | 4bf552a4-b8b3-6fe3-e063-6394a90a722a | 2026-03-01 | Warnings | M005 |
| HAND SANITIZER Watermelon Sugar | ALCOHOL HAND SANITIZER | PT SUPER HOME PRODUCT INDONESIA | 4bf57b6e-c271-b4c6-e063-6394a90a63c6 | 2026-03-01 | Warnings | M005 |
| Clotrimazole | CLOTRIMAZOLE | TRIFECTA PHARMACEUTICALS USA LLC | e0a2a907-9c3a-4c4e-e053-2995a90abb91 | 2026-03-01 | Warnings | M005 |
| FOLUPIA FUNGAL NAIL RENEWAL | FOLUPIA FUNGAL NAIL RENEWAL | Jiangxi Yudexi Pharmaceutical Co., LTD | 4bcacd53-9446-67ec-e063-6294a90a209e | 2026-02-27 | Warnings | M005 |
| Clotrimazole | CLOTRIMAZOLE | Preferred Pharmaceuticals Inc. | d6f5c6b5-5e56-462f-8c47-7986ce53669d | 2026-02-25 | Warnings | M005 |
| Lakeim FUNGAL NAIL RENEWAL Kit | FUNGAL NAIL RENEWAL KIT | Guangzhou Jingliang Cosmetics Co., Ltd. | 4b6aae50-b219-beee-e063-6394a90ab415 | 2026-02-22 | Warnings | M005 |
| Hermon Jock Itch spray. | MICONAZOLE NITRATE 2% | Beautivity LLC | 4b633528-667a-f34e-e063-6294a90a2b3d | 2026-02-21 | Warnings | M005 |
| Lakeim Fungal Nail Repair Pen | FUNGAL NAIL REPAIR PEN | Guangzhou Jingliang Cosmetics Co., Ltd. | 4b23c3a6-51da-7875-e063-6394a90a1467 | 2026-02-18 | Warnings | M005 |
| OSIMOON FUNGAL NAIL RENEWAL | FUNGAL NAIL RENEWAL | Guangzhou Jingliang Cosmetics Co., Ltd. | 4b113f31-1a82-a3ca-e063-6394a90a3231 | 2026-02-17 | Warnings | M005 |
| Hermon Ringworm Antifungal soap. | CLOTRIMAZOLE 1% | Beautivity LLC | 48405a7c-14cd-b3a0-e063-6394a90a9fc9 | 2026-02-13 | Warnings | M005 |
| RoyceDerm Tea Tree Oil Antifungal soap. | TEA TREE OIL ANTIFUNGAL SOAP | RoyceDerm LLC | 3a6d1e32-a38b-3dde-e063-6394a90a88f3 | 2026-02-13 | Warnings | M005 |
| Happy Nuts Jock Itch Powder | MICONAZOLE NITRATE | Suit Up Brands LLC | 42e2d9df-6537-b3a1-e063-6394a90a47b7 | 2026-02-13 | Warnings | M005 |
| Nail Antifungal Treatment | TOLNAFTATE 1% FUNGI NAIL | BENM INC. | 2ea24785-c648-4104-e063-6294a90ab12f | 2026-02-12 | Warnings | M005 |
| Hermon Ringworm Treatment Kit | MICONAZOLE NITRATE 2% AND CLOTRIMAZOLE 1% | Beautivity LLC | 4a9d9c6e-0e0f-d539-e063-6294a90acb57 | 2026-02-12 | Warnings | M005 |
| PHARMBANNER Antifungal Soothing Cream | ANTIFUNGAL SOOTHING CREAM | Shenzhen Xinxin Yunhai Technology Co., Ltd. | 3a077685-4177-bc0d-e063-6294a90a461b | 2026-02-12 | Warnings | M005 |
| PHARMBANNER FUNGAL NAIL RENEWAL | FUNGAL NAIL RENEWAL | Shenzhen Xinxin Yunhai Technology Co., Ltd. | 3a08ec6c-03ae-b9e5-e063-6394a90a0afb | 2026-02-12 | Warnings | M005 |
| PHARMBANNER Tinea Versicolor Cream | TINEA VERSICOLOR CREAM | Shenzhen Xinxin Yunhai Technology Co., Ltd. | 3a095194-c7ea-7f30-e063-6294a90a7ea1 | 2026-02-12 | 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 |