Miconazole 3 Combination Pack - 0363-5203

Manufacturer
WALGREEN COMPANY | Insight Pharmaceuticals
Effective date
2026-07-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-07-21 05:10:23

Label at a glance#

ProductMiconazole 3 Walgreen Company
Active ingredientMICONAZOLE NITRATE
Label structure10 sections

Indications and uses

treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection

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: vaginal insert: with a disposable applicator, place the insert into the vagina at bedtime for three nights in a row. Throw applicator away after use. external cream: squeeze a small amount of cream onto your fingertip. Apply the cream onto the itchy, irritat...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Miconazole nitrate (200 mg in each vaginal insert)

Miconazole nitrate 2% (external cream)

Purpose

OTC - PURPOSE SECTION

Vaginal antifungal

Vaginal antifungal

Uses

INDICATIONS & USAGE SECTION

  • treats vaginal yeast infections
  • relieves external itching and irritation due to a vaginal yeast infection

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
  • 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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the prescription blood thinning medicine 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. 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:

OTC - STOP USE SECTION

  • 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.

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 right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • before using this product read the enclosed consumer information leaflet for complete directions and information
  • adults and children 12 years of age and over:
    • vaginal insert: with a disposable applicator, place the insert into the vagina at bedtime for three nights in a row. Throw applicator away after use.
    • external cream: squeeze a small amount of cream onto your fingertip. Apply the cream onto the itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 days, as needed.

  • children under 12 years of age: ask a doctor.

Other Information

OTHER SAFETY INFORMATION

  • do not use if printed sealed pouches containing vaginal inserts are torn, open or incompletely sealed
  • do not use if seal over tube opening has been punctured 
  • do not purchase if carton is open
  • store at 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

vaginal insert: gelatin, glycerin, hydrogenated vegetable oil base, titanium dioxide

external cream: benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol.

Questions?

OTC - QUESTIONS SECTION

call toll-free 1-8 55-590-5695

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

- Kit Carton

Miconazole 3

Miconazole Nitrate Vaginal Inserts (200 mg) &

Miconazole Nitrate Cream (2%) 

Vaginal Antifungal | 3-Day Treatment

3 Ready-to-Use Vaginal Inserts

Cream for External Relief

Net Wt. 0.32 oz (9 g) TUBE

3 Vaginal Inserts Net Wt. 2.5 g each

Miconazole 3 Miconazole Nitrate Vaginal Inserts (200 mg) & Miconazole Nitrate Cream (2%) Vaginal Antifungal | 3-Day Treatment 3 Ready-to-Use Vaginal Inserts Cream for External R...Miconazole 3 Miconazole Nitrate Vaginal Inserts (200 mg) & Miconazole Nitrate Cream (2%) Vaginal Antifungal | 3-Day Treatment 3 Ready-to-Use Vaginal Inserts Cream for External R...

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

FDA-Initiated Inactive NDC Indexing#

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-52030363-5203-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-01-23full-release2026-06-01 01:33:50

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 43.

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
N020670-002MONISTAT 3 COMBINATION PACKMICONAZOLE NITRATE2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-1684e616aacf4f…
2026-08-18 06:07:402026-07N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-1687673890dc5c…
2021-03-12 10:30 UTC2021-03N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-163f01610625f2…
2019-09-15 20:21 UTC2019-09N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16b00525d2431f…
2019-07-19 19:46 UTC2019-07N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-163f0d92c62455…
2023-05-13 08:27 UTC2023-05N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16053a50430f4f…
2023-01-26 05:58 UTC2023-01N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16f41ea6bd6efb…

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 3 Walgreen CompanyMICONAZOLE NITRATEWALGREEN COMPANY32b373be-9c8e-49b0-a796-8d87f6a20cef2026-07-21WarningsExact identifier
ndc (package): 0363-5203-01
ndc (product): 0363-5203
ndc11 (package): 00363520301
spl id: ebf44c6d-f4bb-48b9-9171-e69fc64e321a
spl set id: 32b373be-9c8e-49b0-a796-8d87f6a20cef

Reported adverse events (FAERS/openFDA)#

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