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. Wash applicator 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 fingertip....
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, pegoxol 7 stearate, purified water
1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.
Actavis
NDC 0472-0730-63
Compare to the active ingredient
in Monistat® 7 Vaginal Cream*
Miconazole 7
Miconazole Nitrate Vaginal Cream, USP 2%
(Miconazole Nitrate 100 mg per applicator)
Vaginal Antifungal
Cures Most Vaginal Yeast Infections
and Relieves Associated External Itching and Irritation
7 Day Vaginal Cream (1 Tube)
With 1 Reusable Applicator
NET WT 1.59 OZ (45 g) Tube

| 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 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| MICONAZOLE NITRATE | ACTIVE INGREDIENT | VW4H1CYW1K | 4 | |
| MICONAZOLE | ACTIVE MOIETY | 7NNO0D7S5M | 4 | |
| BENZOIC ACID | INACTIVE INGREDIENT | 8SKN0B0MIM | 4 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | 4 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 4 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0472-0730 | 0472-0730-41, 0472-0730-63 |
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 |
| APRICOT KERNEL OIL PEG-6 ESTERS | DRG3KJZ1TJ | IACT |
| PEGOXOL 7 STEARATE | 3EW5AXE5X5 | IACT |
| WATER | 059QF0KO0R | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CAPSULE / ORAL | 120 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | GEL / TOPICAL | 0.1 %w/w | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | SUSPENSION / ORAL | 2.5 mg/5ml | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | TABLET / SUBLINGUAL | 2 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUPPOSITORY / RECTAL | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, FILM COATED / ORAL | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CREAM / VAGINAL | 402 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | SUPPOSITORY / RECTAL | 1 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SOAP / TOPICAL | 0.82 %w/w | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | CREAM / VAGINAL | 10 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | FILM / TRANSDERMAL | 11.42 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CREAM / TOPICAL | 2772 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CAPSULE, EXTENDED RELEASE / ORAL | 120 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SYSTEM / TRANSDERMAL | 6.09 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | INJECTION, SOLUTION / INTRAMUSCULAR | 0.2 %w/v | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | PASTE / DENTAL | 95 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, COATED / ORAL | 1.5 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | SOLUTION / ORAL | 100 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | CREAM / TOPICAL | 6 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | MOUTHWASH / BUCCAL | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUSPENSION / AURICULAR (OTIC) | 0.5 %w/v | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | TABLET / ORAL | 8 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, DELAYED RELEASE / ORAL | 5.67 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | AEROSOL, FOAM / TOPICAL | 1 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | FILM / SUBLINGUAL | 0.08 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | CAPSULE, LIQUID FILLED / ORAL | 4 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | TABLET, EXTENDED RELEASE / ORAL | 1 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | SUPPOSITORY / VAGINAL | 2 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OIL / TOPICAL | 43.29 %v/v | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | GEL / TOPICAL | 2.5 %w/w | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | OINTMENT / TOPICAL | 0.01 %w/w | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | TABLET, FILM COATED / ORAL | 0.4 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | SUSPENSION / ORAL | 15 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | INJECTION / INTRAVENOUS | 5 %w/v | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | SOLUTION / ORAL | 5 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | NA | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | DROPS / ORAL | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, CHEWABLE / ORAL | 6 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | OINTMENT / VAGINAL | 0.02 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET / ORAL | 113.75 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SPRAY / TOPICAL | 1379 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | SUSPENSION / RECTAL | 0.1 %w/w | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | CONCENTRATE / ORAL | 12.5 mg/5ml | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OINTMENT / AURICULAR (OTIC) | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SYSTEM / TOPICAL | 654.36 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | GEL / TOPICAL | 7 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | TABLET, COATED / ORAL | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | LOTION / TOPICAL | 1428 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | FILM, EXTENDED RELEASE / TRANSDERMAL | 34 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | ELIXIR / ORAL | 90 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUPPOSITORY / VAGINAL | 30 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | SYRUP / ORAL | 20 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OINTMENT / TOPICAL | 9938 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | SOLUTION / IRRIGATION | 0.02 %w/v | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | TABLET, FILM COATED / ORAL | NA | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | GEL / RECTAL | 11 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | LOTION / TOPICAL | NA |
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 |
|---|---|---|---|---|---|---|
| fb1e266e-2272-4ac5-b8df-0a16251556a1 | f7d96038-ef8b-4f2f-a4c8-b24b2d33037f | 2022-10-04 | Warnings | fb1e266e-2272-4ac5-b8df-0a16251556a1 f7d96038-ef8b-4f2f-a4c8-b24b2d33037f |
Adverse event summaries are temporarily unavailable. Other product information remains available.