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 |
|---|---|---|---|---|---|---|
| Kroger Jock Itch | CLOTRIMAZOLE | Kroger Company | cc536b67-8b0b-4939-b0fb-9a9e4188c4e5 | 2025-07-08 | Warnings | M005 |
| Rite Aid antifungal ringworm | CLOTRIMAZOLE | Rite Aid Corporation | 1ad7cd82-d01b-403e-a2c1-2302db2a78df | 2025-07-08 | Warnings | M005 |
| Conazol | MICONAZOLE NITRATE | Laboratorios Liomont, S.A. de C.V. | 84780538-8618-5750-e053-2a91aa0a6054 | 2025-07-07 | Warnings | M005 |
| Clotrimazole 1% Athletes Foot | CLOTRIMAZOLE | STRATEGIC SOURCING SERVICES LLC | 9aba1345-ef47-4951-8448-a43d6696b616 | 2025-07-07 | Warnings | M005 |
| sunmark antifungal | TOLNAFTATE | Strategic Sourcing Services LLC | d0c30c74-9472-4978-9623-8c7dbeb99411 | 2025-07-07 | Warnings | M005 |
| Clotrimazole | CLOTRIMAZOLE | Sun Pharmaceutical Industries, Inc. | a3a5cbf5-cabb-48d8-8877-74a97f7c0f57 | 2025-07-03 | Warnings | M005 |
| OMZOK ANTIFUNGAL PEN | UNDECYLENIC ACID 25% | Shenzhen Shandian Jingling Technology Co., Ltd. | 38edf699-93af-e550-e063-6294a90a368c | 2025-07-02 | Warnings | M005 |
| meijer Athletes Foot | CLOTRIMAZOLE | Meijer Distribution Inc | fdb15cd8-6726-4150-9b9d-6ef3ee01a5d2 | 2025-07-02 | Warnings | M005 |
| meijer antifungal | TOLNAFTATE | Meijer Distribution Inc | 374af35a-b8bb-4784-bfc8-c3342de875ca | 2025-07-02 | Warnings | M005 |
| Rexall Jock Itch | CLOTRIMAZOLE | Dollar General | 11427a79-f262-4702-9b2e-ec1955a9b2da | 2025-07-02 | Warnings | M005 |
| Rexall Athletes Foot | CLOTRIMAZOLE | Dollar General | 664579a1-a5b0-4a4c-bff6-4347f3e1d3bb | 2025-07-02 | Warnings | M005 |
| Athletes Foot Antifungal | TOLNAFTATE | Dollar General | 43fc473e-c1fd-4245-af38-2e9de5ad91dc | 2025-07-02 | Warnings | M005 |
| SEFUDUN FUNGAL NAIL PATCHES | GLYCERIN | Shenzhen Shandian Jingling Technology Co., Ltd. | 38db97d6-27c8-da99-e063-6294a90aac66 | 2025-07-01 | Warnings | M005 |
| Tolnaftate Antifungal | TOLNAFTATE | Sun Pharmaceutical Industries, Inc. | fa16fa08-fbbd-4f45-b64a-9bffe78e8861 | 2025-07-01 | Warnings | M005 |
| Clotrimazole | CLOTRIMAZOLE | Granules Pharmaceuticals Inc. | 1280353c-9f96-557e-e063-6294a90a10f9 | 2025-06-30 | Warnings | M005 |
| Miconazole | MICONAZOLE NITRATE | Chain Drug Consortium, LLC | 246be926-79ea-4e0c-a3ef-2aa7fc3a52bf | 2025-06-30 | Warnings | M005 |
| Miconazole Nitrate | ANTIFUNGAL LIQUID CONTINUOUS SPRAY | Chain Drug Consortium, LLC | 7f6912a6-a576-4138-bd78-a075a7d24036 | 2025-06-27 | Warnings | M005 |
| Tolnaftate | ANTIFUNGAL LIQUID SPRAY | Rite Aid Corporation | aee58c44-5dba-8acb-e053-2a95a90a23af | 2025-06-21 | Warnings | M005 |
| Miconazole Nitrate | ATHLETES FOOT POWDER SPRAY TALC FREE | Rite Aid Corporation | 5e2f2372-4b79-4b6a-bdea-74289b1e2053 | 2025-06-21 | Warnings | M005 |
| Tolnaftate | JOCK ITCH POWDER | Rite Aid Corporation | b6968587-45c2-d2f8-e053-2a95a90a8401 | 2025-06-21 | 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 |