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 |
|---|---|---|---|---|---|---|
| Miconazole Nitrate | ATHLETES FOOT POWDER SPRAY TALC FREE | Chain Drug Marketing Association | 327095bd-a7c9-291d-e063-6394a90afafa | 2026-06-09 | Warnings | M005 |
| Tolnaftate | ANTIFUNGAL LIQUID SPRAY | Chain Drug Marketing Association | 34b5c11f-710f-60e4-e063-6394a90a990d | 2026-06-09 | Warnings | M005 |
| Tolnafate | TOLNAFTATE POWDER SPRAY | Chain Drug Marketing Association | 342affe8-0a4d-6fe6-e063-6394a90a8dad | 2026-06-09 | Warnings | M005 |
| Miconazole Nitrate | ATHLETES FOOT POWDER SPRAY TALC FREE | Chain Drug Marketing Association | edc2da26-ae46-4175-86ed-83e1a65f6d14 | 2026-06-09 | Warnings | M005 |
| Tolnaftate | ANTIFUNGAL LIQUID SPRAY | Chain Drug Marketing Association | aa97d2ca-bcf4-3ee1-e053-2a95a90a748d | 2026-06-09 | Warnings | M005 |
| Tolnafate | TOLNAFTATE POWDER SPRAY | Chain Drug Marketing Association | 1bd8e096-1717-4656-b52c-086d2f56f070 | 2026-06-09 | Warnings | M005 |
| BODYKOO JOCK ITCH Cream | CLOTRIMAZOLE1% JOCK ITCH CREAM | Jiangxi Yudexi Pharmaceutical Co., LTD | 53553b31-81bb-d293-e063-6294a90aa0a5 | 2026-06-09 | Warnings | M005 |
| BODYKOO ATHLETE FOOT Cream | MICONAZOLE NITRATE2% ATHLETE FOOT CREAM | Jiangxi Yudexi Pharmaceutical Co., LTD | 53561903-54fe-f8ec-e063-6294a90a19fe | 2026-06-09 | Warnings | M005 |
| Clotrimazole Cream | CLOTRIMAZOLE USP1% | Aldermed Inc. | 53bdd76b-6290-f1d3-e063-6394a90a9ff1 | 2026-06-08 | Warnings | M005 |
| Miconazole Cream | MICONAZOLE NITRATE | Aldermed Inc. | 4a7fc48a-c103-dc84-e063-6394a90ab80f | 2026-06-08 | Warnings | M005 |
| Antifungal Powder | MICONAZOLE NITRATE | Aldermed Inc. | 60954089-5220-4f4c-8595-b5ee4562562c | 2026-06-08 | Warnings | M005 |
| Jock Itch Powder | MICONAZOLE NITRATE | Walgreens Company | 06d2f36c-8615-af08-e063-6394a90aa424 | 2026-06-05 | Warnings | M005 |
| Miconazole Nitrate 2% | JOCK ITCH SPRAY | Walgreens Company | cf6cbaf4-beba-6fdf-e053-2995a90a76d2 | 2026-06-04 | Warnings | M005 |
| Charmpoo Antifungal Cream | MICONAZOLE NITRATE 2% ANTIFUNGAL CREAM | Jiangxi Yudexi Pharmaceutical Co., LTD | 5368b131-7537-8679-e063-6394a90a6754 | 2026-06-04 | Warnings | M005 |
| Nail Fungus Treatment Pen | UNDECYLENIC ACID, TOLNAFTATE | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 3fe842e1-b3db-c003-e063-6394a90a46b8 | 2026-06-04 | Warnings | M005 |
| Lasolex AC | MICONAZOLE NITRATE 2% ANTIFUNGAL | PureTek Corporation | 52bb4bc1-e88f-f5ea-e063-6394a90ae1e8 | 2026-06-03 | Warnings | M005 |
| Clotrimazole | CLOTRIMAZOLE | Sun Pharmaceutical Industries, Inc. | 13a14d3c-bfce-42b5-8463-4ec69e94774e | 2026-06-03 | Warnings | M005 |
| Kopa Haiku Antifungal Cream | MICONAZOLE NITRATE 2% | Trovina Co. Ltd | 43cbad59-9899-ab3b-e063-6294a90a9e12 | 2026-06-02 | Warnings | M005 |
| Athletes Foot Cream | CLOTRIMAZOLE | Shenzhen Miandou Technology Co.,Ltd. | 53451e74-719e-9499-e063-6394a90a9e5a | 2026-06-02 | Warnings | M005 |
| Lasolex AL | MICONAZOLE NITRATE 2% ANTIFUNGAL | PureTek Corporation | 534df9be-b47a-03a1-e063-6394a90a265a | 2026-06-02 | 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 |