Indications and uses
treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection
treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection
before using this product read the enclosed consumer information leaflet for complete directions and information adults and children 12 years of age and over: vaginal insert: with a disposable applicator, place the insert into the vagina at bedtime for three nights in a row. Throw applicator away after use. external cream: squeeze a small amount of cream onto your fingertip. Apply the cream onto the itchy, irritat...
Drug Facts
Miconazole nitrate (200 mg in each vaginal insert)
Miconazole nitrate 2% (external cream)
Vaginal antifungal
Vaginal antifungal
For vaginal use only
if you have never had a vaginal yeast infection diagnosed by a doctor.
taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur
ask a health professional before use.
If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).
vaginal insert: gelatin, glycerin, hydrogenated vegetable oil base, titanium dioxide
external cream: benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol.
call toll-free 1-8 55-590-5695
- Kit Carton
Miconazole 3
Miconazole Nitrate Vaginal Inserts (200 mg) &
Miconazole Nitrate Cream (2%)
Vaginal Antifungal | 3-Day Treatment
3 Ready-to-Use Vaginal Inserts
Cream for External Relief
Net Wt. 0.32 oz (9 g) TUBE
3 Vaginal Inserts Net Wt. 2.5 g each
| 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 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0363-5203-01 | 2026-01-20 | C162847 | 48780-1 | f386c649-b8f1-0266-e053-dadaa90a7c1a | Miconazole 3 Combination Pack |
| 0363-5203-01 | 2026-01-20 | C162847 | 48780-1 | f386c649-b8f1-0266-e053-dadaa90a7c1a | Miconazole 3 Combination Pack - 0363-5203 |
| 0363-5203-01 | 2023-01-30 | C162847 | 48780-1 | f386c649-b8f1-0266-e053-dadaa90a7c1a | Miconazole 3 Combination Pack |
| 0363-5203-01 | 2023-01-30 | C162847 | 48780-1 | f386c649-b8f1-0266-e053-dadaa90a7c1a | Miconazole 3 Combination Pack - 0363-5203 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0363-5203 | 0363-5203-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MICONAZOLE NITRATE | VW4H1CYW1K | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| GELATIN | 2G86QN327L | IACT |
| MICONAZOLE NITRATE | VW4H1CYW1K | ACTIB |
| BENZOIC ACID | 8SKN0B0MIM | IACT |
| CETYL ALCOHOL | 936JST6JCN | IACT |
| ISOPROPYL MYRISTATE | 0RE8K4LNJS | IACT |
| POLYSORBATE 60 | CAL22UVI4M | IACT |
| POTASSIUM HYDROXIDE | WZH3C48M4T | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| STEARYL ALCOHOL | 2KR89I4H1Y | IACT |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 2 | 2026-01-23 | full-release | 2026-06-01 01:33:50 |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020670-002 | MONISTAT 3 COMBINATION PACK | MICONAZOLE NITRATE | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N020670-002 | MONISTAT 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | RLD, RS | 1996-04-16 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| Miconazole 3 Walgreen Company | MICONAZOLE NITRATE | WALGREEN COMPANY | 32b373be-9c8e-49b0-a796-8d87f6a20cef | 2026-07-21 | Warnings | 0363-5203-01 0363-5203 00363520301 ebf44c6d-f4bb-48b9-9171-e69fc64e321a 32b373be-9c8e-49b0-a796-8d87f6a20cef |
Adverse event summaries are temporarily unavailable. Other product information remains available.