Miconazole Nitrate

Manufacturer
Rebel Distributors Corp | PSS World Medical, Inc. | STAT RX USA LLC | Dispensing Solutions, Inc. | SCRIPT PAK | Keltman Pharmaceuticals, Inc. | Rebel Distirbutors Corp.
Effective date
2012-09-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:35:03

Label at a glance#

ProductMiconazole Nitrate
Active ingredientMiconazole Nitrate
Label structure11 sections

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)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Miconazole nitrate 100 mg

OTC - PURPOSE SECTION

Vaginal Antifungal

INDICATIONS & USAGE SECTION

Use
• treats vaginal yeast infections

WARNINGS SECTION

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.

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 right away.

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

• 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 SECTION

hydrogenated vegetable oil base

OTC - QUESTIONS SECTION

QUESTION?
call 1-800-922-1038

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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.
 

Miconazole Nitrate 100mg
Miconazole Nitrate 100mg

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MICONAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42254-295-072019-09-24C16284748780-19350213a-3c50-c013-e053-90daa90a1393Miconazole Nitrate, Vaginal Suppositories USP, 100 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-295-07Miconazole Nitrate7 in 1 BOXSUPPOSITORY71

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-295MICONAZOLE NITRATE SUPPOSITORY [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20130329_0e4c7ff6-7bea-4257-bd95-d4d5298ae426.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-295-07EA - Each42254-295c5d44f30-1c71-48b9-892e-201cc456773912013-04-01
0713-0197-57EA - Each0713-0197b8adbe3c-8db9-4c9e-b155-5ce31467b2c112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Miconazole NitrateACTIVE INGREDIENTVW4H1CYW1K1
MiconazoleACTIVE MOIETY7NNO0D7S5M1
Hydrogenated Coconut OilINACTIVE INGREDIENTJY81OXM1OM1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42254-29542254-295-07
0713-0197

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
Miconazole NitrateVW4H1CYW1KACTIB
Hydrogenated Coconut OilJY81OXM1OMIACT

Source Document#

Source XML

Inactive ingredient matches#

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.

Inactive ingredient links page 1 of 1 · 1 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Hydrogenated Coconut OilHYDROGENATED COCONUT OILJY81OXM1OMSUPPOSITORY / RECTALNAExact identifier — unii candidate

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074414-001MICONAZOLE NITRATEMICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-30

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.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-30c2088c7a36db…
2026-09-14 22:38:342026-08A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-3084e616aacf4f…
2026-08-18 06:07:402026-07A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-303f01610625f2…
2019-09-15 20:21 UTC2019-09A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-303a93d1ddd44b…

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0e4c7ff6-7bea-4257-bd95-d4d5298ae4260e4c7ff6-7bea-4257-bd95-d4d5298ae4262012-09-26WarningsExact identifier
spl id: 0e4c7ff6-7bea-4257-bd95-d4d5298ae426
spl set id: 0e4c7ff6-7bea-4257-bd95-d4d5298ae426

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.