FifthPulse Miconazole Nitrate Cream 1oz
- Product NDC
- 69571-016
- 11-digit product format
- 695710016
- Labeler code
- 69571
- Product ID
- 69571-016_3a37a3a8-9d06-926c-e063-6294a90a9ed8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Miconazole Nitrate
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Front Pharmaceutical PLC
- Application
- M005
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-07-19
- Substance
- MICONAZOLE NITRATE
- Active strength
- 20 mg/g
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FifthPulse Miconazole Nitrate Cream 1oz
- Listing expiration
- 2026-12-31
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 |
|---|---|
| 3a37a3a8-9d05-926c-e063-6294a90a9ed8 | 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 |
|---|---|---|---|---|---|---|
| 69571-016-01 | FifthPulse Miconazole Nitrate Cream 1oz | 28.4 g in 1 TUBE | CREAM | 28.4 | 1 |
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 |
|---|---|---|---|---|---|---|
| Defense Antifungal Medicated Bar | TOLNAFTATE | Defense Soap LLC | 812d78ea-a14a-e3a2-e053-2a91aa0a6ff5 | 2026-09-09 | Warnings | M005 |
| Radthary GROIN ANTIFUNGAL Cream | MICONAZOLE NITRATE 2% GROIN ANTIFUNGAL CREAM | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 5b1945f3-84ba-f3dc-e063-6294a90ab8a0 | 2026-09-09 | Warnings | M005 |
| Medline | MICONAZOLE NITRATE | Medline Industries, LP | 0d997d1d-8663-201f-e063-6394a90a285e | 2026-09-08 | Warnings | M005 |
| Remedy Antifungal With Olivamine | MICONAZOLE NITRATE | Medline Industries, LP | 28c5183e-05b4-1754-e054-00144ff8d46c | 2026-09-08 | Warnings | M005 |
| Claravie | MICONAZOLE NITRATE 2% | Gentell LLC | 5afdc429-cb44-703c-e063-6294a90a971a | 2026-09-08 | Warnings | M005 |
| HSENJT Antifungal Cream | MICONAZOLE NITRATE | Huizhou Haosen Trading Co., Ltd. | 5aa587f5-5ddf-542a-e063-6294a90a522b | 2026-09-07 | Warnings | M005 |
| Inlifay ANTIFUNGAL | MICONAZOLE NITRATE 2% ANTIFUNGAL | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a832f39-ac11-d8b3-e063-6394a90acb39 | 2026-09-06 | Warnings | M005 |
| Noicaky FUNGAL NAIL Patches | TOLNAFTATE 1% FUNGAL NAIL PATCHES | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 5adcc5f7-2d47-2ad7-e063-6294a90a4848 | 2026-09-06 | Warnings | M005 |
| LIFE66II ANTIFUNGAL NAIL | UNDECYLENIC ACID 25% ANTIFUNGAL NAIL | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 5ab83796-0780-3b58-e063-6394a90a2e4e | 2026-09-05 | Warnings | M005 |
| FGPER Topical Antifungal Pen | UNDECYLENIC ACID | Guangzhou ChuanMa International Trading Co.,Ltd. | 5abdcbff-6ab1-2f0a-e063-6294a90a57ef | 2026-09-05 | Warnings | M005 |
| AOUGK SALICYLIC ACID WART REMOVER | SALICYLIC ACID | Guangzhou ChuanMa International Trading Co.,Ltd. | 5ac88b51-b46c-5cc6-e063-6394a90af9e5 | 2026-09-05 | Warnings | M005 |
| Jock Itch Powder | MICONAZOLE NITRATE | Premier Brands of America Inc | 5aaacc88-6752-ab47-e063-6394a90af7cd | 2026-09-04 | Warnings | M005 |
| ANTIFUNGAL BODY WASH | TOLNAFTATE | Guangzhou ChuanMa International Trading Co.,Ltd. | 5a695043-f776-df5a-e063-6394a90ac274 | 2026-09-01 | Warnings | M005 |
| KetoconClear Cream | KETOCONAZOLE | Guangzhou Shunfei Network Technology Co., Ltd. | 5a54eebe-5b4a-28dd-e063-6294a90a607f | 2026-08-31 | Warnings | M005 |
| Clotrimazole | CLOTRIMAZOLE | InvaDerm Corporation | 5a5cfed9-0587-7bef-e063-6294a90a64bf | 2026-08-31 | Warnings | M005 |
| Gembooxt RINGWORM Cream | MICONAZOLE NITRATE, HYDROCORTISONE | Guangdong Quadrant Ecological Technology Co., Ltd. | 464a33c3-6d16-0cfd-e063-6294a90abf4b | 2026-08-27 | Warnings | M005 |
| DrAny NAIL FUNGUS TREATMENT | UNDECYLENIC ACID, TOLNAFTATE | Hong Kong Juxin Negosyo Kag Komersyo Co., Limited | 59ef412b-fc7b-0a84-e063-6394a90abf25 | 2026-08-26 | Warnings | M005 |
| Miconazole Nitrate | MICONAZOLE NITRATE | Sun Pharmaceutical Industries, Inc. | 7fd4037e-d350-47b7-a7d9-a43b8e366fa0 | 2026-08-25 | Warnings | M005 |
| WISH HAND SANITIZER pink dragon blossom | ALCOHOL HAND SANITIZER | PT SUPER HOME PRODUCT INDONESIA | 593b3fbe-a8de-1c09-e063-6294a90adc69 | 2026-08-24 | Warnings | M005 |
| Okkazhie WART REMOVER | 40% SALICYLIC ACID | Guangzhou Huixue Biotechnology Co., Ltd. | 59c2d759-d1e9-6c9d-e063-6294a90a04db | 2026-08-23 | Warnings | M005 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 998483 | miconazole nitrate 2 % Topical Cream | PSN | 3a37a3a8-9d05-926c-e063-6294a90a9ed8 | 1 |
| 998483 | miconazole nitrate 20 MG/ML Topical Cream | SCD | 3a37a3a8-9d05-926c-e063-6294a90a9ed8 | 1 |
| 998483 | miconazole nitrate 2 % Topical Cream | SY | 3a37a3a8-9d05-926c-e063-6294a90a9ed8 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 69571-016-01 | 69571001601 | 28.4 g in 1 TUBE (69571-016-01) | 28.4 g | 2025-07-19 | No | No | Current |