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: applicator: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw applicator away after use. use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze a small amount of cream onto your fing...
Drug Facts
Miconazole nitrate, USP 2% (100 mg in each applicator)
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.
benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxyl 7 stearate, purified water
1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68071-3219-7 | 2024-07-30 | C162847 | 48780-1 | ba0f9c33-4014-a910-e053-dadaa90a0b85 | Miconazole Nitrate Vaginal Cream |
| 68071-3219-7 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-4014-a910-e053-dadaa90a0b85 | Miconazole Nitrate Vaginal Cream |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0472-0730-41 | GM - Gram | 0472-0730 | 608157e8-46b9-48c2-b35e-8d1bb87ee876 | 1 | 2012-07-24 |
| 0472-0730-63 | GM - Gram | 0472-0730 | ff103514-2f56-452d-ac6c-27c42aeb5c70 | 1 | 2012-07-24 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68071-3219 | 68071-3219-7 |
| 0472-0730 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BENZOIC ACID | 8SKN0B0MIM | IACT |
| BUTYLATED HYDROXYANISOLE | REK4960K2U | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| WATER | 059QF0KO0R | IACT |
| MICONAZOLE NITRATE | VW4H1CYW1K | ACTIB |
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 |
|---|---|---|---|---|---|---|---|
| A074164-001 | MICONAZOLE 7 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-03-29 |
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 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 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 |
|---|---|---|---|---|---|---|
| 1cc0fb91-ad2e-0741-e063-6394a90ae728 | 55270c7a-72d8-644d-e054-00144ff8d46c | 2024-07-08 | Warnings | 55270c7a-72d8-644d-e054-00144ff8d46c |
Adverse event summaries are temporarily unavailable. Other product information remains available.