Lotrimin AF
- Product NDC
- 11523-0134
- 11-digit product format
- 115230134
- Labeler code
- 11523
- Product ID
- 11523-0134_4526e0ac-2219-182b-e063-6294a90a3a3b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Miconazole nitrate
- Dosage form
- AEROSOL, POWDER
- Route
- TOPICAL
- Labeler
- Bayer Healthcare LLC.
- Application
- M005
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-02-26
- 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
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
- Lotrimin AF
- 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 |
|---|---|
| 998428 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 163996c6-af54-21ac-e063-6394a90ac05c | 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11523-0134-1 | Lotrimin AF | 133 g in 1 CAN | AEROSOL, POWDER | 133 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 11523-0134 | LOTRIMIN AF (MICONAZOLE NITRATE) AEROSOL, POWDER [BAYER HEALTHCARE LLC.] | 1 | Current NDC, 1 package rows | 20240524_163996c6-af54-21ac-e063-6394a90ac05c.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 |
|---|---|---|---|---|---|---|
| FIRST SHIELD | BENZALKONIUM CHLORIDE, LIDOCAINE HCI | Ever Ready First Aid | ee198aa1-ad0d-9185-e053-2a95a90a6595 | 2024-01-15 | Warnings | M005 |
| Ever Ready HAND SANITIZER | ETHYL ALCOHOL | Ever Ready First Aid | ec1af7ef-3c95-9c60-e053-2a95a90acf47 | 2024-01-15 | Warnings | M005 |
| MY MEDIC SUPER SANITIZER | ETHYL ALCOHOL | Sled Distribution, LLC | e7451738-75d5-5dc4-e053-2a95a90a7aee | 2024-01-15 | Warnings | M005 |
| Medical Super | ALCOHOL | Beijing HKKY Medical Tech. Co., Ltd. | ed2649c6-d971-4338-8745-cd0a40f7b0c2 | 2024-01-13 | Warnings | M005 |
| ER Hand Sanitizer Packets | ALCOHOL | EVER READY FIRST AID | d0b6d09c-26e0-45c7-8d37-7d42143b2e31 | 2024-01-11 | Warnings | M005 |
| clotrimazole | CLOTRIMAZOLE | Proficient Rx LP | eeb241a3-93ee-4b74-8cbb-65713d15e7e0 | 2024-01-01 | Warnings | M005 |
| Clotrimazole | CLOTRIMAZOLE | Proficient Rx LP | ba1dc4a4-073f-4f30-bb9c-9ed043700431 | 2024-01-01 | Warnings | M005 |
| RUGBY ANTIFUNGAL CLOTRIMAZOLE | CLOTRIMAZOLE | Proficient Rx LP | 7c64553b-589c-4e65-a6f0-b2847bbbe8a6 | 2024-01-01 | Warnings | M005 |
| Dr. Scholls Instant Cool Athletes foot treatment with Menthol | TOLNAFTATE | Scholl's Wellness Company | dad00745-e411-35b8-e053-2a95a90a1000 | 2023-12-21 | Warnings | M005 |
| TINEACIDE | TOLNAFTATE | Blaine Labs Inc. | 273eb424-5dc3-40c8-9ea7-2f732cbd11c9 | 2023-12-21 | Warnings | M005 |
| TERPENICOL ANTIFUNGAL | UNDECYLENIC ACID | Blaine Labs Inc. | a020334e-aac9-4ea5-a0ea-8e5b021fe2eb | 2023-12-21 | Warnings | M005 |
| TERPENICOL | UNDECYLENIC ACID | Blaine Labs Inc. | efd99ed1-07d3-4862-ae47-883f7d1c91c6 | 2023-12-21 | Warnings | M005 |
| sunmark antifungal | TOLNAFTATE | A-S Medication Solutions | 6f85fbb0-297c-4949-83f2-ed9a52172154 | 2023-12-16 | Warnings | M005 |
| Miconazole Nitrate | MICONAZOLE NITRATE | A-S Medication Solutions | 7a0ef38a-9584-4e67-ba86-c31f86da1ed0 | 2023-12-11 | Warnings | M005 |
| Miconazole Nitrate | MICONAZOLE NITRATE | A-S Medication Solutions | 7d284f6f-a970-49fe-b45a-d5c6c2688bc2 | 2023-12-11 | Warnings | M005 |
| Hi Vetic | TOLNAFTATE | Sato Pharmaceutical Co., Ltd. | 2096e241-3ed3-49cd-88c4-71db1fd2934a | 2023-12-06 | Warnings | M005 |
| Undecylenic Acid | UNDECYLENIC ACID | Chemco Corporation | 7391b53f-5567-1f45-e053-2991aa0a4fce | 2023-12-05 | Warnings | M005 |
| Hi Vetic | TOLNAFTATE | Sato Pharmaceutical Co., Ltd. | be92b480-56e8-4371-adbc-40fe74f6747c | 2023-12-01 | Warnings | M005 |
| Antifungal Cream | ANTIFUNGAL | BluePoint Laboratories | b4c4240f-f84c-ec5e-e053-2a95a90aa082 | 2023-11-17 | Warnings | M005 |
| Antifungal Cream | ANTIFUNGAL | BluePoint Laboratories | b564f971-2a9b-a605-e053-2995a90aee69 | 2023-11-17 | Warnings | M005 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 998428 | miconazole nitrate 2 % Powder Spray | PSN | 163996c6-af54-21ac-e063-6394a90ac05c | 2 |
| 998428 | miconazole nitrate 0.02 MG/MG Powder Spray | SCD | 163996c6-af54-21ac-e063-6394a90ac05c | 2 |
| 998428 | miconazole nitrate 2 % Powder Spray | SY | 163996c6-af54-21ac-e063-6394a90ac05c | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 11523-0134-1 | 11523013401 | 133 g in 1 CAN (11523-0134-1) | 133 g | 2024-02-26 | No | No | Current |