Indications and uses
• treats repeat vaginal yeast infections • relieves external itching and irritation due to a repeat vaginal yeast infection
• treats repeat vaginal yeast infections • relieves external itching and irritation due to a repeat vaginal yeast infection
• do not use if seal over tube opening has been punctured or cannot be seen • store at room temperature 15°-30°C (59°-86°F). Avoid heat over 30°C or 86°F.
Miconazole nitrate 2% (100 mg in each applicator)
Miconazole nitrate 2% (as external cream)
Vaginal antifungal
• treats repeat vaginal yeast infections
• relieves external itching and irritation due to a repeat vaginal yeast infection
For vaginal use only
Do not use if you have never had a vaginal yeast infection diagnosed by a doctor
Ask a doctor before use if you have
• vaginal itching and discomfort for the first time
• lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition.
• vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system.
• been exposed to the human immunodeficiency virus (HIV) that causes AIDS.
Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medication warfarin, because bleeding or bruising may occur.
When using this product
• do not use tampons, douches, spermicides, or other vaginal products
• do not have vaginal intercourse
• condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs)
Stop use and ask a doctor if
• symptoms do not get better in 3 days
• symptoms last more than 7 days
• you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting,or foul-smelling vaginal discharge
ask a health professional before use.
If swallowed, get medical help or contact a Poison Control Center right away.
• before using this product read the enclosed consumer information leaflet for complete instructions
• adults and children 12 years of age and over:
• applicator: insert one applicatorful into the vagina at bedtime for 7 nights in a row
• external cream: squeeze a small amount of cream onto your fingertip. Gently apply the cream onto the itchy, irritated
skin outside the vagina. Use daily for up to 7 days as needed
• children under 12 years of age: ask a doctor
• do not use if seal over tube opening has been punctured or cannot be seen
• store at room temperature 15°-30°C (59°-86°F). Avoid heat over 30°C or 86°F.
benzoic acid, BHA, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water
CommUnityCare Federally Qualified Health Centers
MICONAZOLE
2% VAGINAL
CREAM
Date:
Name:
Dr.
USE AS DIRECTED
123456
1/1/01
MICONAZOLE 2% VAG.CRM 45gNDC 76413-318-45
Batch: 123456
Lot: 123456
Exp: 1/1/01
G&W LABS
Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

| Class | Version | Type | Effective |
|---|---|---|---|
| MICONAZOLE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| 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 |
|---|---|---|---|---|---|
| 76413-318-45 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-2637-f424-e053-dadaa90a57ce | Miconazole nitrate |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76413-318-45 | Miconazole Nitrate | 45 g in 1 TUBE, WITH APPLICATOR | CREAM | 45 | 1 | |
| 76413-318-45 | Miconazole Nitrate | 1 in 1 CARTON | CREAM | 1 | 1 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0713-0252-37 | GM - Gram | 0713-0252 | 4eef55c7-51cd-4f3e-aa0f-27909ec64d7b | 1 | 2012-07-24 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 76413-318 | 76413-318-45 |
| 0713-0252 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Miconazole Nitrate | VW4H1CYW1K | ACTIB |
| Benzoic Acid | 8SKN0B0MIM | IACT |
| Butylated Hydroxyanisole | REK4960K2U | IACT |
| Mineral Oil | T5L8T28FGP | IACT |
| Peg-5 Oleate | 0240V77G50 | IACT |
| Pegoxol 7 Stearate | 3EW5AXE5X5 | IACT |
| Water | 059QF0KO0R | IACT |
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 |
|---|---|---|---|---|---|---|---|
| A074366-001 | MICONAZOLE NITRATE | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 |
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 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 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 |
|---|---|---|---|---|---|---|
| 6f218797-be08-4b07-8c82-21e2b57f0eb1 | 0878a5d4-d6c7-4e66-8956-9bd1acd9dfd4 | 2016-04-21 | Warnings | 6f218797-be08-4b07-8c82-21e2b57f0eb1 0878a5d4-d6c7-4e66-8956-9bd1acd9dfd4 |
Adverse event summaries are temporarily unavailable. Other product information remains available.