Storage and handling
• store at 15°-30°C (59°-86°F). Avoid heat over 30°C (86°F). • do not use if suppository wrapper is missing or damaged (each suppository is individually wrapped)
• store at 15°-30°C (59°-86°F). Avoid heat over 30°C (86°F). • do not use if suppository wrapper is missing or damaged (each suppository is individually wrapped)
Miconazole nitrate 100 mg
Vaginal Antifungal
Use
• treats vaginal yeast infections
WARNINGS
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
• 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 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 by this product and fail to prevent pregnancy or sexually transmitted diseases (STDs).
• do not have vaginal intercourse
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, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge
• In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.
If pregnant or breast-feeding, ask a health professional before use
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
• before using this product, read the enclosed brochure for complete instructions
• adults and children 12 years of age and over:
• insert 1 suppository into the vagina at bedtime for 7 nights in a row
• wash applicator after each use
• children under 12 years of age: ask a doctor
• store at 15°-30°C (59°-86°F). Avoid heat over 30°C (86°F).
• do not use if suppository wrapper is missing or damaged (each suppository is individually wrapped)
hydrogenated vegetable oil base
QUESTION?
call 1-800-922-1038
Miconazole Nitrate Vaginal Suppositories USP, 100 mg
NDC 42254-295-07
7 Day Treatment
Miconazole Nitrate Vaginal Suppositories USP, 100 mg
Cures Most Vaginal Yeast Infections
Contains 7 Vaginal Suppositories
Drug Facts
Active ingredient (in each vaginal suppository) Purpose
Miconazole nitrate 100 mg.........................................................................................Vaginal antifungal
Use
• treats vaginal yeast infections
Warnings
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
• 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 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 by this product and fail to prevent pregnancy or sexually transmitted diseases (STDs).
• do not have vaginal intercourse
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, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge
If pregnant or breast-feeding, ask a health professional before use
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
• before using this product, read the enclosed brochure for complete instructions
• adults and children 12 years of age and over:
• insert 1 suppository into the vagina at bedtime for 7 nights in a row • wash applicator after each use
• children under 12 years of age: ask a doctor
Drug Facts
(continued)
Other information
• store at 15°-30°C (59°-86°F). Avoid heat over 30°C (86°F).
• do not use if suppository wrapper is missing or damaged (each suppository is individually wrapped)
Inactive ingredient
hydrogenated vegetable oil base
Drug Facts (continued)
Questions? call
1-800-922-1038
Manufactured by: G&W Laboratories, Inc.
111 Coolidge Street
South Plainfield, NJ 07080
Visit our website @
www.gwlabs.com
Repackaged by: Rebel Distributors Corp.
3607 Old Conejo Rd.
Thousand Oaks, CA 91320
TAMPER-EVIDENT: For your safety each suppository is individually wrapped. If a suppository is unwrapped or there are signs of tampering, DO NOT USE.

| Class | Version | Type | Effective |
|---|---|---|---|
| MICONAZOLE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| 42254-295-07 | 2019-09-24 | C162847 | 48780-1 | 9350213a-3c50-c013-e053-90daa90a1393 | Miconazole Nitrate, Vaginal Suppositories USP, 100 mg |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42254-295-07 | Miconazole Nitrate | 7 in 1 BOX | SUPPOSITORY | 7 | 1 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42254-295-07 | EA - Each | 42254-295 | c5d44f30-1c71-48b9-892e-201cc4567739 | 1 | 2013-04-01 |
| 0713-0197-57 | EA - Each | 0713-0197 | b8adbe3c-8db9-4c9e-b155-5ce31467b2c1 | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Miconazole Nitrate | ACTIVE INGREDIENT | VW4H1CYW1K | 1 | |
| Miconazole | ACTIVE MOIETY | 7NNO0D7S5M | 1 | |
| Hydrogenated Coconut Oil | INACTIVE INGREDIENT | JY81OXM1OM | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 42254-295 | 42254-295-07 |
| 0713-0197 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Miconazole Nitrate | VW4H1CYW1K | ACTIB |
| Hydrogenated Coconut Oil | JY81OXM1OM | 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 |
|---|---|---|---|---|---|---|
| Hydrogenated Coconut Oil | HYDROGENATED COCONUT OIL | JY81OXM1OM | SUPPOSITORY / RECTAL | 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 |
|---|---|---|---|---|---|---|---|
| A074414-001 | MICONAZOLE NITRATE | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 |
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 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A074414-001 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY / VAGINAL | 1997-04-30 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| 0e4c7ff6-7bea-4257-bd95-d4d5298ae426 | 0e4c7ff6-7bea-4257-bd95-d4d5298ae426 | 2012-09-26 | Warnings | 0e4c7ff6-7bea-4257-bd95-d4d5298ae426 0e4c7ff6-7bea-4257-bd95-d4d5298ae426 |
Adverse event summaries are temporarily unavailable. Other product information remains available.