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 | 2026-10-15 | |
| excluded package | package | 53329-080 | 53329-080-57 | 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 |
|---|---|---|---|---|---|---|
| Maximum Strength Antifungal Liquid | TOLNAFTATE | FSA Store Inc. | fae36294-68b6-bf14-e053-6394a90aaacd | 2025-10-27 | Warnings | M005 |
| EVERLIT CARE Hand Sanitizer | ETHYL ALCOHOL | Nantong Health & Beyond Hygienic Products Inc. | 58dd955e-e68b-4fbd-90c8-a85b15c00dc7 | 2025-10-25 | Warnings | M005 |
| EVERLIT CARE Hand Sanitizer | ETHYL ALCOHOL | EVERLIT GLOBAL INC. | 1360cdd8-b2b2-4af9-b6ff-af1101d49e18 | 2025-10-25 | Warnings | M005 |
| Tolnafate | TOLNAFTATE POWDER SPRAY | Better Living Brands LLC | ccff8d63-ee7d-eada-e053-2995a90ac5dd | 2025-10-24 | Warnings | M005 |
| Tolnaftate | ANTIFUNGAL LIQUID SPRAY | Better Living Brands LLC | ccff4830-6d81-2a0d-e053-2a95a90a154c | 2025-10-24 | Warnings | M005 |
| Liquid Antifungal Treatment | TOLNAFTATE | Hudson Health LLC | 14a9efd8-e49f-12fa-e063-6394a90aa8a0 | 2025-10-24 | Warnings | M005 |
| Miconazole Nitrate | ANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREE | Hudson Health LLC | 36ec5f05-5d1c-25df-e063-6394a90a9dd9 | 2025-10-24 | Warnings | M005 |
| Signature Care Antifungal Cream Tolnaftate 1% | TOLNAFTATE | BETTER LIVING BRANDS LLC | b02b81d6-8db4-927b-e053-2995a90a3958 | 2025-10-24 | Warnings | M005 |
| Winco Foods Tolnaftate | TOLNAFTATE | Winco Foods, LLC | 218f7613-1401-4f1b-bf46-576b536825af | 2025-10-23 | Warnings | M005 |
| zourunan MULTI-PURPOS TREATMENT | MULTI-PURPOS TREATMENT | Guchutang Biotechnology (Longyan) Co., Ltd | 41bad254-b674-9521-e063-6294a90ab634 | 2025-10-22 | Warnings | M005 |
| zourunan FOOT ODOR PROBIOTIC | FOOT ODOR | Guchutang Biotechnology (Longyan) Co., Ltd | 41bbc02c-53f2-2d94-e063-6394a90ac9ec | 2025-10-22 | Warnings | M005 |
| Signature Care Athletes Foot | CLOTRIMAZOLE | Safeway | c1750c17-4afb-aecf-e053-2a95a90af35b | 2025-10-22 | Warnings | M005 |
| Athletes Foot | TOLNAFTATE | Imperial Feet B.V. | 1189c7d8-7c8f-ae01-e063-6294a90ac270 | 2025-10-21 | Warnings | M005 |
| Fungicure Liquid Gel | CLOTRIMAZOLE | Kobayashi Healthcare International, Inc. | dfd03852-29bd-4e16-97f3-64dfde5f8ff8 | 2025-10-21 | Warnings | M005 |
| Athlete Foot Medicated bar | TOLNAFTATE | Beautivity LLC | 3b2cedb2-18f4-f571-e063-6394a90a6418 | 2025-10-21 | Warnings | M005 |
| Athletes Foot | TOLNAFTATE | Quantum, Inc. | 6cb95707-9831-41f1-a23e-9e3356141fdc | 2025-10-20 | Warnings | M005 |
| Toe Fungus | TOLNAFTATE | Imperial Feet B.V. | 118a6c97-4e8a-050a-e063-6294a90a1108 | 2025-10-17 | Warnings | M005 |
| Inlifay ANTIFUNGAL | TOLNAFTATE | Guangzhou Haishi Biological Technology Co., Ltd. | 4141574d-7a5b-c437-e063-6394a90aacb6 | 2025-10-16 | Warnings | M005 |
| Tolnaftate | ANTIFUNGAL LIQUID SPRAY | HY-VEE, INC | 415ecf9b-460d-82b6-e063-6294a90a0e05 | 2025-10-16 | Warnings | M005 |
| SEACALL NAIL REVIVE SERUM | NAIL REVIVE SERUM | Guangdong Quadrant Ecological Technology Co., Ltd. | 1f4d0c9a-361e-72e5-e063-6394a90a7cda | 2025-10-15 | 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 |