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 | 2026-10-15 | |
| excluded package | package | 53329-080 | 53329-080-58 | 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 |
|---|---|---|---|---|---|---|
| Tolnaftate | TOLNAFTATE | Sheffield Pharmaceuticals LLC | ca52af37-c3a2-414c-a24a-a37a92925133 | 2025-02-20 | Warnings | M005 |
| Dr Sheffield Athletes Foot | CLOTRIMAZOLE | Sheffield Pharmaceuticals LLC | b8b8e6b2-1022-4592-91ba-3cf94c7cf318 | 2025-02-19 | Warnings | M005 |
| UKVOA Toenail Fungus Treatment | TOLNAFTATE 1% FUNGI NAIL | Jiashen International Trade Limited | 2e3cde7b-850e-f9d2-e063-6394a90adb18 | 2025-02-16 | Warnings | M005 |
| UKOVA FOOT ODOR PROBIOTIC | TOLNAFTATE 1% FUNGI NAIL | Jiashen International Trade Limited | 2de0225d-dd85-e2da-e063-6294a90a050b | 2025-02-11 | Warnings | M005 |
| Dr. Scholls Instant Cool Athletes Foot Wipes | TOLNAFTATE | Cosco International, Inc. | cde656a9-7841-4a73-a2f4-f5a76a3e15c1 | 2025-02-06 | Warnings | M005 |
| Silka Athletes Foot | MICONAZOLE NITRATE | Genomma Lab USA | 307104a2-2df6-43b0-bf3f-f4d93d3e40f1 | 2025-02-05 | Warnings | M005 |
| MICONAZOLE Nitrate | MICONAZOLE NITRATE | NuCare Pharmaceuticals,Inc. | fd7dd2eb-03a7-ef1f-e053-6294a90a8557 | 2025-02-04 | Warnings | M005 |
| Molecular AF | TOLNAFTATE | Renu Laboratories, LLC | 1b47e687-29cf-48ce-8bc3-ac8f44f05baa | 2025-02-03 | Warnings | M005 |
| Dermatool Fungal Nail Treatment | TOLNAFTATE 1% | Papalo Group LLC | 2d2c0e12-123d-75bd-e063-6394a90ae546 | 2025-01-31 | Warnings | M005 |
| 70% Isopropyl Alcohol | ISOPROPYL ALCOHOL | IDO PHARM | d5833c6f-81dd-6ff6-e053-2995a90ac76d | 2025-01-30 | Warnings | M005 |
| AWAS ALCOHOLSPRAY | ALCOHOL | IDO PHARM | 03010837-0289-3e08-e063-6394a90a7d04 | 2025-01-30 | Warnings | M005 |
| ELON Dual Defense Anti Fungal Formula | UNDECYLENIC ACID | Little Giant Holdings LLC | 45c4567d-7876-6459-e054-00144ff88e88 | 2025-01-28 | Warnings | M005 |
| DCH Labs Antifungal Jock | MICONAZOLE NITRATE 2% | Derma Care Research Labs, LLC | fc749882-2e1e-cad3-e053-6294a90a33ca | 2025-01-27 | Warnings | M005 |
| Antifungal Pen | UNDECYLENIC ACID 25% | XF Agencija Limited | a15d4512-0fc6-424f-9dd3-ab433d9b7a26 | 2025-01-27 | Warnings | M005 |
| Mata Hongos | UNDECYLENIC ACID | Vitamex USA, Corp | 21ca7edb-dde3-5846-e063-6394a90a3cc0 | 2025-01-23 | Warnings | M005 |
| Povidone Iodine Scrub | POVIDONE-IODINE | Jianerkang Medical Co., Ltd | 53cb4c0d-40b5-4cf3-b122-fd6dd654883f | 2025-01-23 | Warnings | M005 |
| NATUREPLEX TOLNAFTATE ANTIFUNGAL | TOLNAFTATE | Natureplex, LLC | 575b8645-9166-4242-a74f-f4aa4acaaf3d | 2025-01-15 | Warnings | M005 |
| Tobcharm Antifungal Treatment Cream | ANTIFUNGAL TREATMENT CREAM | Guangzhou Zanming Trading Co., Ltd. | 2ba241cc-2767-1190-e063-6294a90ac66b | 2025-01-13 | Warnings | M005 |
| MICONAZOLE Nitrate 2% | MICONAZOLE NITRATE | Akron Pharma Inc. | 8933f939-098a-4257-8d9c-4d5c3240e9a6 | 2025-01-10 | Warnings | M005 |
| ANTI-ITCH FEMININE CARE | HYDROCORTISONE 0.5% | OL PHARMA TECH, LLC Drs PHARMACY | d6fa5ff3-ebdc-222d-e053-2a95a90a88d5 | 2025-01-09 | 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 |