Micatin
- Product NDC
- 65197-103
- 11-digit product format
- 651970103
- Labeler code
- 65197
- Product ID
- 65197-103_d9d5ec5c-ee44-42cd-9579-969f3ae1f166
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Miconazole nitrate
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- WellSpring Pharmaceutical Corporation
- Application
- M005
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2009-06-24
- Marketing end
- 2026-11-30
- Substance
- MICONAZOLE NITRATE
- Active strength
- 20 mg/g
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS]
- NDC exclude flag
- No
- 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
- Micatin
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MICONAZOLE NITRATE | 20 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| VW4H1CYW1K | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 96c56ba1-c3a8-48ce-ab58-550959485e3c | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| 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 |
|---|---|---|---|---|---|---|
| 65197-103-05 | Micatin | 14 g in 1 TUBE | CREAM | 14 | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65197-103-05 | GM - Gram | 65197-103 | efc568b5-c1ec-4767-b2b3-a2c85664732d | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| MICONAZOLE NITRATE | ACTIVE INGREDIENT | VW4H1CYW1K | MICATIN (MICONAZOLE NITRATE) CREAM [WELLSPRING PHARMACEUTICAL CORPORATION] | 5 | |
| MICONAZOLE | ACTIVE MOIETY | 7NNO0D7S5M | MICATIN (MICONAZOLE NITRATE) CREAM [WELLSPRING PHARMACEUTICAL CORPORATION] | 5 | |
| BENZOIC ACID | INACTIVE INGREDIENT | 8SKN0B0MIM | MICATIN (MICONAZOLE NITRATE) CREAM [WELLSPRING PHARMACEUTICAL CORPORATION] | 5 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | MICATIN (MICONAZOLE NITRATE) CREAM [WELLSPRING PHARMACEUTICAL CORPORATION] | 5 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | MICATIN (MICONAZOLE NITRATE) CREAM [WELLSPRING PHARMACEUTICAL CORPORATION] | 5 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Medi-First Clotrimazole 1% ANTIFUNGAL Cream | CLOTRIMAZOLE | Unifirst First Aid Corporation | 522eeb91-8378-32f4-e063-6394a90aff43 | 2026-05-20 | Warnings | M005 |
| Kopa Haiku Antifungal Cream | MICONAZOLE NITRATE 2% | Trovina Co. Ltd | 47cf1251-5965-045a-e063-6394a90ab04f | 2026-05-19 | Warnings | M005 |
| APUREE PRO Nailtific Maximum Strength Antifungal Patches | APUREE PRO NAILTIFIC MAXIMUM STRENGTH ANTIFUNGAL PATCHES | Guangzhou Meixi Biotechnology Co., Ltd. | 5218bd5d-53b4-107f-e063-6394a90ae769 | 2026-05-18 | M005 | |
| APUREE Pro Nailtific Maximum Strength Dual-Action Antifungal Pen | APUREE PRO NAILTIFIC MAXIMUM STRENGTH DUAL-ACTION ANTIFUNGAL PEN | Guangzhou Meixi Biotechnology Co., Ltd. | 521a0e40-a218-fabb-e063-6294a90ae9a2 | 2026-05-18 | Warnings | M005 |
| Beukow Antifungal Pen | UNDECYLENIC ACID 25% ANTIFUNGAL PEN | Jiangxi Yudexi Pharmaceutical Co., LTD | 511d1edf-dfda-477c-e063-6294a90aa423 | 2026-05-17 | Warnings | M005 |
| Nail Repair Pen | NAIL REPAIR PEN | Shenzhen Earth Surface Trading Co., Ltd. | 520f6514-6660-d6a8-e063-6394a90adf82 | 2026-05-17 | Warnings | M005 |
| Fungicure Intensive | CLOTRIMAZOLE | Kobayashi Healthcare International, Inc. | 1f1b413f-278e-434f-8590-4cf731663f5c | 2026-05-15 | Warnings | M005 |
| Dr Scholls Fungal Nail Clear and Cure Tolnaftate Antifungal | TOLNAFTATE | Scholl's Wellness Company LLC | 8abd6d8e-c69e-4374-ace8-d42b2d3e171e | 2026-05-14 | Warnings | M005 |
| Dr.Scholl s Odor X Athlete s Foot | TOLNAFTATE | Scholl's Wellness Company LLC | 0e864882-5e00-491e-a008-0762c131637a | 2026-05-14 | Warnings | M005 |
| Athletes Foot | TOLNAFTATE | Rugby Laboratories | 50c46cf5-3e64-9e0f-e063-6294a90a2317 | 2026-05-14 | Warnings | M005 |
| TOSSOYA Rainforest SecretGuard Antibacterial Quick-Cleanse Wipes | TOSSOYA RAINFOREST SECRETGUARD ANTIBACTERIAL QUICK-CLEANSE WIPES | Shenzhen Shierjie Biological Engineering Co., LTD | 3d53463d-8d8e-9030-e063-6294a90ab454 | 2026-05-13 | Warnings | M005 |
| Anti-Fungal Powder | MICONAZOLE NITRATE | CVS Pharmacy | 1651bdd7-ab15-7a2d-e063-6294a90a8b91 | 2026-05-11 | Warnings | M005 |
| Lightning X Hand Cleanser | ETHYL ALCOHOL | Nantong Health & Beyond Hygienic Products Inc. | 51861f1e-8961-e876-e063-6394a90a2fd0 | 2026-05-11 | Warnings | M005 |
| APUREE Nailtific Maximum Strength Antifungal Patches PRO | APUREE NAILTIFIC MAXIMUM STRENGTH ANTIFUNGAL PATCHES PRO | Guangzhou Meixi Biotechnology Co., Ltd | 5189ebc5-8ee5-1b2c-e063-6294a90af5c8 | 2026-05-11 | Warnings | M005 |
| APUREE Nailtific Maximum Strength Dual-Action Antifungal Pen Pro | APUREE NAILTIFIC MAXIMUM STRENGTH DUAL-ACTION ANTIFUNGAL PEN PRO | Guangzhou Meixi Biotechnology Co., Ltd. | 518abf2b-6ac8-ab9b-e063-6294a90ae693 | 2026-05-11 | Warnings | M005 |
| CLOTRIMAZOLE | CLOTRIMAZOLE | Rugby Laboratories, Inc. | 2c60e631-5930-4420-886d-eb1990c720b6 | 2026-05-11 | Warnings | M005 |
| Tolfyra | TOLNAFTATE | Oncora Pharma, LLC | b28ee9f2-fc45-4336-b374-be7aa51d44e9 | 2026-05-11 | Warnings | M005 |
| clotrimazole | CLOTRIMAZOLE | A-S Medication Solutions | c0f58a0d-a304-41f9-bbdf-c2e488230cf0 | 2026-05-11 | Warnings | M005 |
| Inlifay ANTIFUNGAL | TOLNAFTATE | Guangdong Aimu Biological Technology Co., Ltd | 5148b838-d26e-cf66-e063-6394a90ae469 | 2026-05-09 | Warnings | M005 |
| HuiPoLii NAIL PFLASTER | TOLNAFTATE 1% NAIL PFLASTER | Jiangxi Yudexi Pharmaceutical Co., LTD | 514b1c2d-cecb-30a2-e063-6394a90af266 | 2026-05-08 | Warnings | M005 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 998509 | Micatin 2 % Topical Cream | PSN | 96c56ba1-c3a8-48ce-ab58-550959485e3c | 11 |
| 998483 | miconazole nitrate 2 % Topical Cream | PSN | 96c56ba1-c3a8-48ce-ab58-550959485e3c | 11 |
| 998509 | miconazole nitrate 20 MG/ML Topical Cream [Micatin] | SBD | 96c56ba1-c3a8-48ce-ab58-550959485e3c | 11 |
| 998483 | miconazole nitrate 20 MG/ML Topical Cream | SCD | 96c56ba1-c3a8-48ce-ab58-550959485e3c | 11 |
| 998509 | Micatin 2 % Topical Cream | SY | 96c56ba1-c3a8-48ce-ab58-550959485e3c | 11 |
| 998509 | Micatin 20 MG/ML Topical Cream | SY | 96c56ba1-c3a8-48ce-ab58-550959485e3c | 11 |
| 998483 | miconazole nitrate 2 % Topical Cream | SY | 96c56ba1-c3a8-48ce-ab58-550959485e3c | 11 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 65197-103-05 | 65197010305 | 14 g in 1 TUBE (65197-103-05) | 14 g | 2009-06-24 | 2026-11-30 | No | No | Current |