Secura Antifungal
- Product NDC
- 69740-328
- 11-digit product format
- 697400328
- Labeler code
- 69740
- Product ID
- 69740-328_4e7a7f19-4af6-d825-e063-6394a90aa2d4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- MICONAZOLE NITRATE
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Smith & Nephew Medical Ltd
- Application
- M005
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2003-08-01
- Substance
- MICONAZOLE NITRATE
- Active strength
- 20 mg/g
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 69740-328 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 1332a3947898… | d4bfe170f9cd… | ||
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 69740-328 | 69740-328-00 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 1332a3947898… | d4bfe170f9cd… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Secura Antifungal
- Brand name suffix
- Greaseless
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MICONAZOLE NITRATE | 20 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| VW4H1CYW1K | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 998483 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9be600e4-76ec-4071-a8ec-a0b23155271d | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 3a55f4fb-5aec-4c88-0ff7-4d608ad4866a | Product name | 1 | 20140508 |
| 5b9a7965-36d2-8412-dcaf-f76a65411611 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69740-328-00 | 2024-03-12 | C162847 | 48780-1 | 1030e365-1b60-111a-e063-dadaa90a10e2 | Secura Antifungal |
| 69740-328-00 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1b60-111a-e063-dadaa90a10e2 | Secura Antifungal |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69740-328-00 | Secura AntifungalGreaseless | 57 g in 1 TUBE | CREAM | 57 | 13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69740-328 | SECURA ANTIFUNGAL GREASELESS (MICONAZOLE NITRATE) CREAM SECURA ANTIFUNGAL EXTRA THICK (MICONAZOLE NITRATE) CREAM [SMITH & NEPHEW MEDICAL LTD] | 12 | Current NDC, Legacy NDC, 1 package rows | 20250418_9be600e4-76ec-4071-a8ec-a0b23155271d.zip |
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 |
|---|---|---|---|---|---|---|
| Tolnaftate | TOLNAFTATE | Sheffield Pharmaceuticals LLC | ca52af37-c3a2-414c-a24a-a37a92925133 | 2025-02-20 | Warnings | M005 |
| Dr Sheffield Athletes Foot | CLOTRIMAZOLE | Sheffield Pharmaceuticals LLC | b8b8e6b2-1022-4592-91ba-3cf94c7cf318 | 2025-02-19 | Warnings | M005 |
| UKVOA Toenail Fungus Treatment | TOLNAFTATE 1% FUNGI NAIL | Jiashen International Trade Limited | 2e3cde7b-850e-f9d2-e063-6394a90adb18 | 2025-02-16 | Warnings | M005 |
| UKOVA FOOT ODOR PROBIOTIC | TOLNAFTATE 1% FUNGI NAIL | Jiashen International Trade Limited | 2de0225d-dd85-e2da-e063-6294a90a050b | 2025-02-11 | Warnings | M005 |
| Dr. Scholls Instant Cool Athletes Foot Wipes | TOLNAFTATE | Cosco International, Inc. | cde656a9-7841-4a73-a2f4-f5a76a3e15c1 | 2025-02-06 | Warnings | M005 |
| Silka Athletes Foot | MICONAZOLE NITRATE | Genomma Lab USA | 307104a2-2df6-43b0-bf3f-f4d93d3e40f1 | 2025-02-05 | Warnings | M005 |
| MICONAZOLE Nitrate | MICONAZOLE NITRATE | NuCare Pharmaceuticals,Inc. | fd7dd2eb-03a7-ef1f-e053-6294a90a8557 | 2025-02-04 | Warnings | M005 |
| Molecular AF | TOLNAFTATE | Renu Laboratories, LLC | 1b47e687-29cf-48ce-8bc3-ac8f44f05baa | 2025-02-03 | Warnings | M005 |
| Dermatool Fungal Nail Treatment | TOLNAFTATE 1% | Papalo Group LLC | 2d2c0e12-123d-75bd-e063-6394a90ae546 | 2025-01-31 | Warnings | M005 |
| 70% Isopropyl Alcohol | ISOPROPYL ALCOHOL | IDO PHARM | d5833c6f-81dd-6ff6-e053-2995a90ac76d | 2025-01-30 | Warnings | M005 |
| AWAS ALCOHOLSPRAY | ALCOHOL | IDO PHARM | 03010837-0289-3e08-e063-6394a90a7d04 | 2025-01-30 | Warnings | M005 |
| ELON Dual Defense Anti Fungal Formula | UNDECYLENIC ACID | Little Giant Holdings LLC | 45c4567d-7876-6459-e054-00144ff88e88 | 2025-01-28 | Warnings | M005 |
| DCH Labs Antifungal Jock | MICONAZOLE NITRATE 2% | Derma Care Research Labs, LLC | fc749882-2e1e-cad3-e053-6294a90a33ca | 2025-01-27 | Warnings | M005 |
| Antifungal Pen | UNDECYLENIC ACID 25% | XF Agencija Limited | a15d4512-0fc6-424f-9dd3-ab433d9b7a26 | 2025-01-27 | Warnings | M005 |
| Mata Hongos | UNDECYLENIC ACID | Vitamex USA, Corp | 21ca7edb-dde3-5846-e063-6394a90a3cc0 | 2025-01-23 | Warnings | M005 |
| Povidone Iodine Scrub | POVIDONE-IODINE | Jianerkang Medical Co., Ltd | 53cb4c0d-40b5-4cf3-b122-fd6dd654883f | 2025-01-23 | Warnings | M005 |
| NATUREPLEX TOLNAFTATE ANTIFUNGAL | TOLNAFTATE | Natureplex, LLC | 575b8645-9166-4242-a74f-f4aa4acaaf3d | 2025-01-15 | Warnings | M005 |
| Tobcharm Antifungal Treatment Cream | ANTIFUNGAL TREATMENT CREAM | Guangzhou Zanming Trading Co., Ltd. | 2ba241cc-2767-1190-e063-6294a90ac66b | 2025-01-13 | Warnings | M005 |
| MICONAZOLE Nitrate 2% | MICONAZOLE NITRATE | Akron Pharma Inc. | 8933f939-098a-4257-8d9c-4d5c3240e9a6 | 2025-01-10 | Warnings | M005 |
| ANTI-ITCH FEMININE CARE | HYDROCORTISONE 0.5% | OL PHARMA TECH, LLC Drs PHARMACY | d6fa5ff3-ebdc-222d-e053-2a95a90a88d5 | 2025-01-09 | Warnings | M005 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 998483 | miconazole nitrate 2 % Topical Cream | PSN | 9be600e4-76ec-4071-a8ec-a0b23155271d | 13 |
| 998483 | miconazole nitrate 20 MG/ML Topical Cream | SCD | 9be600e4-76ec-4071-a8ec-a0b23155271d | 13 |
| 998483 | miconazole nitrate 2 % Topical Cream | SY | 9be600e4-76ec-4071-a8ec-a0b23155271d | 13 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69740-328-00 | 69740032800 | 57 g in 1 TUBE (69740-328-00) | 57 g | 2003-08-01 | 0000-00-00 | No | No | Current |