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 |
|---|---|---|---|---|---|---|
| Terramed Just Think Comfort Armor Antifungal Medicated | TOLNAFTATE | Rida LLC | 33994035-b429-4ead-8885-98e38b25059a | 2026-02-04 | Warnings | M005 |
| BeamBalm FUNGL NAIL | TOLNAFTATE 1% FUNGL NAIL | Jiangxi Yudexi Pharmaceutical Co., LTD | 49f72e97-2393-dca8-e063-6394a90a6f10 | 2026-02-03 | Warnings | M005 |
| MARIANP FUNGAL NAIL PATCHES | TEA TREE OIL | Shenzhen Shandian Jingling Technology Co., Ltd. | 49d1dbc4-91be-1f5c-e063-6394a90a55ec | 2026-02-02 | Warnings | M005 |
| Jorvinl Nail Fungus Treatment | UNDECYLENIC ACID 25% | Guangzhou Huixue Biotechnology Co., Ltd. | 49d88844-9cb0-f575-e063-6394a90a0d2f | 2026-02-02 | Warnings | M005 |
| FlyLeaf Fungal Nail Treatment | TOLNAFTATE 1% | Guangzhou Huixue Biotechnology Co., Ltd. | 49d8e823-b7a2-8c18-e063-6294a90a7745 | 2026-02-02 | Warnings | M005 |
| BLDAXN FUNGUS NAIL PEN | UNDECYLENIC ACID, TOLNAFTATE | Guangdong Quadrant Ecological Technology Co., Ltd. | 49e291e1-be83-8926-e063-6394a90a13c2 | 2026-02-02 | Warnings | M005 |
| INSTANT HAND SANITIZER | INSTANT HAND SANITIZER | NINGBO MEITELI COSMETICS CO., LTD | 49e44671-5d79-aa8e-e063-6294a90a9d2e | 2026-02-02 | Warnings | M005 |
| Alveora FOOT ODOR PROBIOTIC | TOLNAFTATE 1% FOOT ODOR PROBIOTIC | Jiangxi Yudexi Pharmaceutical Co., LTD | 49964c81-1c86-e1f5-e063-6394a90a7d08 | 2026-01-30 | Warnings | M005 |
| Alveora NAIL FUNGUS TREATMENT | ALVEORA NAIL FUNGUS TREATMENT | Jiangxi Yudexi Pharmaceutical Co., LTD | 49985b01-ef96-0d27-e063-6294a90ac169 | 2026-01-30 | Warnings | M005 |
| ProClearz Laser Antifungal | TOLNAFTATE | Rooftop Consumer Health, inc | 53648135-7b79-4775-993b-48fa1298b747 | 2026-01-29 | Warnings | M005 |
| Proclearz Professional Fungal Shield | TOLNAFTATE | Rooftop Consumer health, inc | 51125209-c279-4abb-af07-500982651cab | 2026-01-29 | Warnings | M005 |
| TheraCare Antifungal Cream | TOLNAFTATE | Veridian Healthcare | e9478d74-c0d9-4b88-a474-b88d10f52571 | 2026-01-29 | Warnings | M005 |
| BLDAXN NAIL REPAIR PEN | UNDECYLENIC ACID | Guangdong Quadrant Ecological Technology Co., Ltd. | 4992fbd8-f205-2ff6-e063-6394a90a7d06 | 2026-01-29 | Warnings | M005 |
| Jock Itch Clotrimazole Antifungal | CLOTRIMAZOLE | WalMart | a7677ad4-5239-40da-809a-501b91caedbf | 2026-01-29 | Warnings | M005 |
| ProCure Antifungal | MICONAZOLE NITRATE 2% | Twin Med LLC | 3d380fe4-a870-cb55-e063-6394a90a9c90 | 2026-01-28 | Warnings | M005 |
| Antifungal Liquid | TOLNAFTATE | Wal-Mart Stores, Inc. | 401f4993-0200-f1fd-e063-6294a90a6589 | 2026-01-28 | Warnings | M005 |
| Foot Powder | MICONAZOLE NITRATE | Walgreens Company | 137a493b-6ed5-d649-e063-6294a90ac442 | 2026-01-28 | Warnings | M005 |
| Miconazole Nitrate | JOCK ITCH SPRAY | Wal-Mart Stores, Inc. | 76259769-9923-4856-a160-a738bc8a72f0 | 2026-01-27 | Warnings | M005 |
| Signature Select Instant Hand Sanitizer Wipes with Aloe Vera | ALCOHOL | Living Better Brands LLC | cf4b671f-697a-47d3-921e-2de433073918 | 2026-01-26 | Warnings | M005 |
| Signature Select Advanced Hand Sanitizer with Aloe Vera | ALCOHOL | Living Better Brands LLC | cbf0fead-0729-460b-82c0-1596c995cf2b | 2026-01-26 | 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 |