Soothe And Cool Treat
- Product NDC
- 53329-080
- 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 product | product | 53329-080 | D | Discontinued by firm | 2026-10-12 | ||
| excluded product | product | 53329-080 | D | Discontinued by firm | 2026-10-12 | ||
| excluded package | package | 53329-080 | 53329-080-57 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 53329-080 | 53329-080-58 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 53329-080 | 53329-080-57 | 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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 53329-080-58 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 53329-080-58 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 53329-080-57 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 53329-080-57 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 53329-080-58 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 53329-080-58 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 53329-080-57 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 53329-080-57 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 53329-080-58 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 53329-080-58 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 53329-080-57 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 53329-080-57 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 53329-080-58 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 53329-080-58 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 53329-080-57 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 53329-080-57 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 53329-080-58 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 53329-080-58 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 53329-080-57 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 53329-080-57 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 53329-080-58 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 53329-080-58 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 53329-080-57 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 53329-080-57 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 53329-080-58 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 53329-080-57 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 53329-080-58 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 53329-080-57 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 53329-080-58 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 53329-080-57 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 53329-080-58 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 53329-080-57 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 53329-080-58 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 53329-080-57 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 53329-080-58 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 53329-080-57 | 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 |
|---|---|---|---|---|---|---|
| Hongo Killer | UNDECYLENIC ACID | Efficient Laboratories Inc | 5c433182-0c0c-4a0a-8dd8-a14f60e52425 | 2024-10-14 | Warnings | M005 |
| Miconazole nitrate | ANTIFUNGAL MICONAZOLE LIQUID CONTINUOUS SPRAY | Meijer Distribution Inc | 6c2ebe17-994d-41c8-bacb-87b6a63b2db4 | 2024-10-14 | Warnings | M005 |
| Miconazole Nitrate | ANTIFUNGAL | McKesson | 8dcca44a-16c7-7262-e053-2a95a90a1b23 | 2024-10-10 | Warnings | M005 |
| CAREALL Clotrimazole | CLOTRIMAZOLE | New World Imports, Inc | ebc565bb-e56c-43ba-a5cb-d2fad2aafc4a | 2024-10-07 | Warnings | M005 |
| Micotrin AL | TOLNAFTATE | PureTek Corporation | cc0fba1e-82c5-42fd-e053-2995a90af249 | 2024-10-02 | Warnings | M005 |
| Mycozyl AL | TOLNAFTATE | PureTek Corporation | b82c9a8a-f6f1-dca6-e053-2995a90a47f9 | 2024-10-02 | Warnings | M005 |
| MY MEDIC SUPER SANITIZER | ALCOHOL | Nantong Health & Beyond Hygienic Products Inc. | f19971b1-2aeb-4c37-82b0-9525026cff7a | 2024-10-02 | Warnings | M005 |
| Micotrin AC | CLOTRIMAZOLE | PureTek Corporation | cbe4dd18-c9ef-a4e4-e053-2995a90a5289 | 2024-10-01 | Warnings | M005 |
| Micotrin AP | MICONAZOLE NITRATE | PureTek Corporation | cbe3d495-cdee-2343-e053-2a95a90a5b82 | 2024-10-01 | Warnings | M005 |
| Mycozyl AC | CLOTRIMAZOLE | PureTek Corporation | b676d257-3cfd-7f24-e053-2995a90a546e | 2024-10-01 | Warnings | M005 |
| Mycozyl AP | MICONAZOLE NITRATE | PureTek Corporation | b3c46a30-7ff2-0dc4-e053-2995a90aa571 | 2024-10-01 | Warnings | M005 |
| AOSI HEALTHCARE HAND SANITIZER | ALCOHOL | Nantong Health & Beyond Hygienic Products Inc. | 59d631d0-d8ae-45a8-a7a9-26de9cc427b3 | 2024-09-25 | Warnings | M005 |
| Clotrimazole 1% | CLOTRIMAZOLE | Dabur India Limited | 22916978-303f-e62a-e063-6394a90a2100 | 2024-09-20 | Warnings | M005 |
| Mentholatum Heel Revival Cream | MENTHOLATUM HEEL REVIVAL CREAM | The Mentholatum Company | 21b643c2-eb6e-8939-e063-6394a90aaeac | 2024-09-09 | Warnings | M005 |
| VAGISTEN-V 7 DAY | MICONAZOLE NITRATE | OPMX LLC | a5bfa501-5ae1-4434-bc31-995d0665b99e | 2024-09-04 | Warnings | M005 |
| COTTON ON FOUNDATION Tropical Hand Sanitizer | ETHYL ALCOHOL | Nantong Health & Beyond Hygienic Products Inc. | 3645359c-06a2-4b97-b982-c54e4a0b8cda | 2024-09-04 | Warnings | M005 |
| COTTON ON FOUNDATION Coastal Hand Sanitizer | ETHYL ALCOHOL | Nantong Health & Beyond Hygienic Products Inc. | 645c09dc-15a4-481f-a605-f12fb8f8e9bd | 2024-09-04 | Warnings | M005 |
| Publix Athletic Foot | CLOTRIMAZOLE 1% | PUBLIX SUPER MARKETS, INC. | d9f99680-5636-4136-a7c6-c3643339e6b4 | 2024-08-02 | Warnings | M005 |
| ANTIFUNGAL FOOT | TOLNAFTATE | Universal Distribution Center LLC | 10579848-5793-4d72-ad5f-62d191c71074 | 2024-07-16 | Warnings | M005 |
| MY MEDIC SUPER SANITIZER | ETHYL ALCOHOL | Nantong Health & Beyond Hygienic Products Inc. | cd8f4ccd-b75e-4de0-87c0-150dfb6e0bf3 | 2024-07-02 | 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 |
| 53329-080-58 | 53329008058 | 56 g in 1 TUBE (53329-080-58) | 56 g | 2007-01-01 | 0000-00-00 | No | No | Current |