Indications and uses
• treats vaginal yeast infections • relieves external itching and irritation due to a vaginal yeast infection
Miconazole 7
- Manufacturer
- Preferred Pharmaceuticals Inc.
- Effective date
- 2026-07-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- weekly-update
- Hydrated at
- 2026-07-17 21:44:10
Label at a glance#
ProductMiconazole 7
Active ingredientMICONAZOLE NITRATE
Label structure11 sections
Dosage and administration
• before using this product read the enclosed consumer information leaflet for complete directions and information • adults and children 12 years of age and over: o applicator: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Wash applicator after use. o 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 fi...
Storage and handling
• to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use • do not use if foil seal on tube opening is broken or missing • do not purchase if carton is open • store at room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] excursions permitted to 15°-30°C (59°-86°F) • before using any medication, read all label directions. Keep carton, it contains important informat...
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient
Miconazole nitrate USP, 2% (100 mg in each applicator)
Purpose
Vaginal antifungal
Uses
- treats vaginal yeast infections
- relieves external itching and irritation due to a vaginal yeast infection
Warnings
For vaginal use only
OTC - DO NOT USE SECTION
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
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur.
When using this product
- do not use tampons, douches, spermicides or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs).
- do not have vaginal intercourse
- mild increase in vaginal burning, itching or irritation may occur
- if you do not get complete relief ask a doctor before using another product
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
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- 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. Apply to itchy, irritated skin outside the vagina (vulva). Use 2 times daily for up to 7 days as needed.
- children under 12 years of age: ask a doctor
Other information
- to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use
- do not use if foil seal on tube opening is broken or missing
- do not purchase if carton is open
- store at room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] excursions permitted to 15°-30°C (59°-86°F)
- before using any medication, read all label directions. Keep carton, it contains important information.
Inactive ingredients
benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water
Questions?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
SPL UNCLASSIFIED SECTION
Distributed by: H2-Pharma, LLC
Montgomery, AL 36117
Relabeled By: Preferred Pharmaceuticals Inc.
PRINCIPAL DISPLAY PANEL - 45 g Tube Carton
NDC 68788-7917-4
*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
Relieves associated external itching and irritation
Net wt. 1.59 oz (45 g) Tube
7 day vaginal cream (1 tube) with 1 reusable applicator
H2pharma
Relabeled By: Preferred Pharmaceuticals Inc.
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Data code | Code 128 | 399 | miconazole-01.jpg | |
| Data code | Data Matrix | **081225* | miconazole-01.jpg |
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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61269-730-41 | GM - Gram | 61269-730 | c08120f8-57b4-41e7-b73b-aebd8fac5f5c | 1 | 2021-05-05 |
| 61269-730-63 | GM - Gram | 61269-730 | f361e5bb-302a-4a82-818f-5ac9991e1ac8 | 1 | 2021-04-08 |
Products#
Every source-derived product name is available through these pages.
- Miconazole 7
- Miconazole Nitrate
- MICONAZOLE
- BENZOIC ACID
- BUTYLATED HYDROXYANISOLE
- MINERAL OIL
- APRICOT KERNEL OIL PEG-6 ESTERS
- PEGOXOL 7 STEARATE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68788-7917 | 68788-7917-4 |
| 61269-730 |
Ingredients#
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 |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 5 | 2025-08-12 | full-release | 2026-06-01 01:10:11 |
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| 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 Orange Book product history#
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | c2088c7a36db… | ||
| 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… |
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 |
|---|---|---|---|---|---|---|
| Miconazole 7 | MICONAZOLE NITRATE | Preferred Pharmaceuticals Inc. | 99c66cbd-7063-4b4c-b827-4f2fcb6ed67f | 2026-07-08 | Warnings | 68788-7917-4 68788-7917 68788791704 8459106a-4717-4369-99f6-a0f926a9241f 99c66cbd-7063-4b4c-b827-4f2fcb6ed67f |
| Miconazole 7 | MICONAZOLE NITRATE | H2-Pharma, LLC | 4bf1a555-a24f-4807-ac13-db19c55cf280 | 2023-01-13 | Warnings | 61269-730 |
| Miconazole 7 | MICONAZOLE NITRATE | H2-Pharma, LLC | 67dc7d38-a663-48d5-9abf-b3bd8dc0eddf | 2023-01-13 | Warnings | 61269-730 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.