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 |
|---|---|---|---|---|---|---|
| Recuren Plus Jock Itch Cream | MICONAZOLE NITRATE 2% | REGENEREN PLUS LTD | 450dab4d-168a-60b8-e063-6394a90ab303 | 2026-05-08 | Warnings | M005 |
| OSIMOON FUNGAL NAIL TREATMENT Kit | FUNGAL NAIL TREATMENT KIT | Guangzhou Jingliang Cosmetics Co., Ltd. | 51465ebf-3b5f-e2bf-e063-6394a90adaf2 | 2026-05-07 | Warnings | M005 |
| RoyceDerm Tinea Antifungal Cream | MICONAZOLE NITRATE 2% | RoyceDerm LLC | 40089a7d-c893-4e90-e063-6294a90aa6f9 | 2026-05-06 | Warnings | M005 |
| QQE Fungal Nail Treatment | TOLNAFTATE 1% | Guangzhou Huixue Biotechnology Co., Ltd. | 510ff705-e2cb-b77b-e063-6394a90a9e72 | 2026-05-05 | Warnings | M005 |
| Clotrimazole | CLOTRIMAZOLE | Akron Pharma Inc | 692d7e0f-50d4-4abb-8c74-36bc98064fe7 | 2026-05-05 | Warnings | M005 |
| Clotrimazole | CLOTRIMAZOLE | KJD Pharma Private Limited | 5115f8e3-5668-5207-e063-6394a90a7650 | 2026-05-05 | Warnings | M005 |
| NATURAL CURES FUNGAL NAIL Patches | TOLNAFTATE 1% FUNGAL NAIL PATCHES | Jiangxi Yudexi Pharmaceutical Co., LTD | 510a8df7-ea6d-d634-e063-6294a90aea53 | 2026-05-04 | Warnings | M005 |
| Hand Sanitizer Lemon Scented | ALCOHOL | Taizhou Juheng Biotechnology Co., Ltd. | 21387234-0ac9-499d-97bf-90bccc4782ad | 2026-05-04 | Warnings | M005 |
| Uauko Fungal Nail Treatment | FUNGAL NAIL TREATMENT | Guangzhou Jingliang Cosmetics Co., Ltd. | 50d16854-ab90-d6cf-e063-6294a90a21b1 | 2026-05-02 | Warnings | M005 |
| NAIL RENEW | TOLNAFTATE | Nailrenew Corp | a0df4ee5-1276-41b7-a1c4-8fcbfc7f97b5 | 2026-05-02 | Warnings | M005 |
| MHB SKIN HYDRATING HAND SANITIZER, CITRUS PEEL | ALCOHOL HAND SANITIZER SPRAY | CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD. | 4934c20d-6295-aeb8-e063-6394a90adfeb | 2026-04-30 | Warnings | M005 |
| MHB SKIN HYDRATING HAND SANITIZER, MELON MUSE 35ml | ALCOHOL HAND SANITIZER | CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD. | 4931f2e4-0fef-a8c7-e063-6394a90ac16e | 2026-04-30 | Warnings | M005 |
| MINADCIN TOENAIL FUNGUS PEN | UNDECYLENIC ACID 25% TOENAIL FUNGUS PEN | Jiangxi Yudexi Pharmaceutical Co., LTD | 50a9264e-aba0-0ae2-e063-6294a90acfff | 2026-04-30 | Warnings | M005 |
| ANTIFUNGAL | UNDECYLENIC ACID | Chemco Corporation | 50893584-c1c6-9ffa-e063-6394a90ae177 | 2026-04-29 | Warnings | M005 |
| MHB SKIN HYDRATING HAND SANITIZER, LILY MIST | ALCOHOL HAND SANITIZER | CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD. | 50949ae2-3ebe-08d2-e063-6394a90a2046 | 2026-04-29 | Warnings | M005 |
| MHB SKIN HYDRATING HAND SANITIZER SANTAL WAVE 35ml | ALCOHOL HAND SANITIZER | CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD. | 493120ee-0c5c-b704-e063-6394a90a8c19 | 2026-04-29 | Warnings | M005 |
| ProBliva Antifungal Scrub .soap. Bar | TOLNAFTATE 1% | CAVTECH HOLDING LLC | 5090a9ad-3df7-6699-e063-6394a90a72f7 | 2026-04-28 | Warnings | M005 |
| FifthPulse Clotrimazole Antifungal | CLOTRIMAZOLE | WeCare Products LLC | 9f5ea297-5a25-42cc-bd47-4159108b0023 | 2026-04-27 | Warnings | M005 |
| YAMANGU FUNGAL NAIL REPAIR PEN | UNDECYLENIC ACID 25% TOLNAFTATE 1% FUNGAL NAIL REPAIR PEN | Jiangxi Yudexi Pharmaceutical Co., LTD | 501cf54a-31da-6db2-e063-6394a90a65f8 | 2026-04-23 | Warnings | M005 |
| Medicated Athletes Foot Powder | MICONAZOLE NITRATE | Premier Brands of America Inc. | 38cc0c66-82b5-bac4-e063-6294a90a23f0 | 2026-04-23 | 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 |