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 | 2026-10-05 | |
| excluded package | package | 53329-080 | 53329-080-57 | D | Discontinued by firm | 2026-10-05 |
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 |
|---|---|---|---|---|---|---|
| BlissCare tea tree oil antifungal | TOLNAFTATE | Guangdong Aimu Biological Technology Co., Ltd | 58f9ff8c-d75a-ad1d-e063-6294a90af3dc | 2026-08-21 | Warnings | M005 |
| GPPEE TOENAIL FUNGUS TREATMENT | UNDECYLENIC ACID 25% | Guangzhou Huixue Biotechnology Co., Ltd. | 598d05bc-459d-71cf-e063-6394a90a1932 | 2026-08-21 | Warnings | M005 |
| Claravie | MICONAZOLE NITRATE | Gentell LLC | 596d590b-e7ff-4be3-e063-6294a90a871d | 2026-08-20 | Warnings | M005 |
| WISH ADVANCED HAND SANITIZER SALTED CARAMEL PISTACHIO | ALCOHOL HAND SANITIZER | PT SUPER HOME PRODUCT INDONESIA | 595f9f2a-7857-0752-e063-6394a90af8de | 2026-08-19 | Warnings | M005 |
| WISH ADVANCED HAND SANITIZER DRAGONFRUIT JASMINE | ALCOHOL HAND SANITIZER | PT SUPER HOME PRODUCT INDONESIA | 595fd84a-fead-3818-e063-6394a90aa4f1 | 2026-08-19 | Warnings | M005 |
| WISH HAND SANITIZER vanilla cream | ALCOHOL HAND SANITIZER | PT SUPER HOME PRODUCT INDONESIA | 594bb903-2406-abb9-e063-6294a90a1cee | 2026-08-18 | Warnings | M005 |
| WISH HAND SANITIZER rose petal | ALCOHOL HAND SANITIZER | PT SUPER HOME PRODUCT INDONESIA | 594befe7-1701-02a2-e063-6294a90a236c | 2026-08-18 | Warnings | M005 |
| WISH ADVANCED HAND SANITIZER SWEETR GUAVA FRESH COCONUT | ALCOHOL HAND SANITIZER | PT SUPER HOME PRODUCT INDONESIA | 594c32b7-6905-4ab9-e063-6294a90a1db3 | 2026-08-18 | Warnings | M005 |
| BYT BANGYTONG FOLLICULITIS | 5% BENZOYL PEROXIDE FOLLICULITIS | Shenzhen Jindali Technology Co., Ltd | 595363f9-6aee-93a5-e063-6394a90a0f0e | 2026-08-18 | Warnings | M005 |
| Clotrimazole 1% Athletes Foot | CLOTRIMAZOLE | Shield Line LLC | 9ddb13cd-34ed-2d63-e053-2a95a90ad9da | 2026-08-18 | Warnings | M005 |
| WISH ADVANCED HAND SANITIZER BLACK PLUM VANILLA | ALCOHOL HAND SANITIZER | PT SUPER HOME PRODUCT INDONESIA | 595f0c9f-645d-a047-e063-6294a90a996a | 2026-08-18 | Warnings | M005 |
| FUNGAL NAIL PATCHES | TOLNAFTATE | Yunqi Cosmetics (Shenzhen) Co., Ltd | 5939c492-6481-ddae-e063-6294a90a40bb | 2026-08-17 | Warnings | M005 |
| WISH HAND SANITIZER cherry rouge | ALCOHOL HAND SANITIZER | PT SUPER HOME PRODUCT INDONESIA | 593a7fc9-8d56-f9cb-e063-6294a90a3dae | 2026-08-17 | Warnings | M005 |
| APUREE Maximum Strength Athletes Foot Antifungal | APUREE MAXIMUM STRENGTH ATHLETES FOOT ANTIFUNGAL | Guangzhou Meixi Biotechnology Co., Ltd. | 593dc9a3-ae04-5642-e063-6294a90adb4b | 2026-08-17 | Warnings | M005 |
| MENTOL CHINO FORTE | METHYL SALICYLATE, MENTHOL, CAMPHOR | LABORATORIOS H.G. C.A. | 12652c98-e2a8-21fc-e063-6394a90a94cb | 2026-08-17 | Warnings | M005 |
| WISH HAND SANITIZER Sea Salt Green Herbs | ALCOHOL HAND SANITIZER | PT SUPER HOME PRODUCT INDONESIA | 59259ea7-f1bb-9688-e063-6394a90afb3c | 2026-08-16 | Warnings | M005 |
| WISH HAND SANITIZER Marshmallow Vanilla | ALCOHOL HAND SANITIZER | PT SUPER HOME PRODUCT INDONESIA | 5925e9a7-eb93-c0e3-e063-6294a90ad265 | 2026-08-16 | Warnings | M005 |
| WISH HAND SANITIZER Lychee Vanilla Milk | ALCOHOL HAND SANITIZER | PT SUPER HOME PRODUCT INDONESIA | 592625c8-cbc5-f864-e063-6394a90aeb9d | 2026-08-16 | Warnings | M005 |
| WISH HAND SANITIZER Banana Cream Sugar | ALCOHOL HAND SANITIZER | PT SUPER HOME PRODUCT INDONESIA | 5912d7e8-94a7-e8b9-e063-6394a90a74d6 | 2026-08-15 | Warnings | M005 |
| WISH HAND SANITIZER Caramel Vanilla Popcorn | ALCOHOL HAND SANITIZER | PT SUPER HOME PRODUCT INDONESIA | 591317be-856e-1374-e063-6394a90a7aaf | 2026-08-15 | 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 |