Miconazole 7

Manufacturer
Strategic Sourcing Services LLC
Effective date
2025-09-09
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
full-release
Hydrated at
2026-06-01 01:13:16

Label at a glance#

ProductMiconazole 7
Active ingredientMICONAZOLE NITRATE
Label structure10 sections

Dosage and administration

before using this product read the enclosed consumer information leaflet for complete instructions and information 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 use. children under 12 years: ask a doctor

Label contents#

Full prescribing information#

Active ingredient (in each vaginal suppository)

OTC - ACTIVE INGREDIENT SECTION

Miconazole nitrate, USP 100 mg

Purpose

OTC - PURPOSE SECTION

Vaginal antifungal

Use

INDICATIONS & USAGE SECTION

  • treats vaginal yeast infections

Warnings

WARNINGS SECTION

For vaginal use only

Do not use

OTC - DO NOT USE SECTION

if you have never had a vaginal yeast infection diagnosed by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • vaginal itching and discomfort for the first time
  • vaginal yeast infections often (such as once a month or 3 in 6 months). You may have a more serious condition. You could be pregnant or have a medical condition, such as diabetes or a weakened immune system.
  • lower abdominal, back, or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge
  • been exposed to the human immunodeficiency virus (HIV) that causes AIDS

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking a prescription blood thinning medicine, such as warfarin, because bleeding or bruising may occur

When using this product

OTC - WHEN USING SECTION

  • do not use tampons, douches, spermicides or other vaginal products
  • do not use condoms or diaphragms. They may be damaged by this product and not prevent pregnancy or sexually transmitted diseases (STDs).
  • do not have vaginal intercourse (sex)
  • mild increase in vaginal burning, itching or irritation may occur

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • side effects occur.
  • symptoms do not get better after 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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • before using this product read the enclosed consumer information leaflet for complete instructions and information
  • 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 use.
  • children under 12 years: ask a doctor

Other information

OTHER SAFETY INFORMATION

  • do not purchase if carton is open
  • each suppository is individually wrapped. Do not use if wrapper is missing or damaged.
  • store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature] excursions permitted to 15º-30ºC (59º-86ºF).

Inactive ingredient

INACTIVE INGREDIENT SECTION

hydrogenated vegetable oil

Questions?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARETO MONISTAT® 7 ACTIVE INGREDIENT*

miconazole 7

Vaginal Suppositories

Miconazole Nitrate Vaginal

Suppositories, USP 100 mg

Vaginal antifungal

Cures most vaginal yeast infections

7 VAGINAL SUPPOSITORIES WITH 1 REUSABLE PLASTIC APPLICATOR

*This product is not affiliated with, manufactured by, or produced by the makers or owners of Monistat®

Distributed by McKesson Corp.,

via Strategic Sourcing Services LLC,

Memphis, TN 38141

www.sunmarkbrand.com

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SUNMARK Vaginal Suppositories
SUNMARK Vaginal Suppositories

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
992780miconazole nitrate 100 MG Vaginal InsertPSN14
992780miconazole nitrate 100 MG Vaginal InsertSCD14

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49348-833-61Miconazole 77 in 1 APPLICATORSUPPOSITORY714

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-833-61EA - Each49348-83391bde22e-afb4-40cf-9552-9e3aeca0a3db12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1K3
MICONAZOLEACTIVE MOIETY7NNO0D7S5M3
HYDROGENATED PALM KERNEL OILINACTIVE INGREDIENTFM8D1RE2VP3

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49348-83349348-833-61

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Source Document#

Source XML

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
A073507-001MICONAZOLE NITRATEMICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-19

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 13:18:302026-09A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-19c2088c7a36db…
2026-09-14 22:38:342026-08A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-1984e616aacf4f…
2026-08-18 06:07:402026-07A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-1987673890dc5c…
2021-03-12 10:30 UTC2021-03A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-193f01610625f2…
2019-09-15 20:21 UTC2019-09A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-19b00525d2431f…
2019-07-19 19:46 UTC2019-07A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-19ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-193f0d92c62455…
2023-05-13 08:27 UTC2023-05A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-19053a50430f4f…
2023-01-26 05:58 UTC2023-01A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-193a93d1ddd44b…

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
Miconazole 7MICONAZOLE NITRATEStrategic Sourcing Services LLC89132802-beb1-42f4-8da4-39918fc5c4dd2025-09-09WarningsExact identifier
ndc (package): 49348-833-61
ndc (product): 49348-833
ndc11 (package): 49348083361
spl id: 274e7b2b-9aaa-4b8e-8cc0-a88ca1cbecde
spl set id: 89132802-beb1-42f4-8da4-39918fc5c4dd

Reported adverse events (FAERS/openFDA)#

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