FDA.reportPublic FDA data

Miconazole 1 Combination Pack

Manufacturer
WALGREEN COMPANY | Insight Pharmaceuticals
Effective date
2026-01-23
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-09-08 02:02:40

Label at a glance#

ProductMiconazole 1 Walgreens
Active ingredientMiconazole Nitrate
Label structure11 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 the applicator, place the vaginal insert into the vagina. Throw applicator away. 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 fo...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Miconazole nitrate 1200 mg (in 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 if

OTC - DO NOT USE SECTION

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 the applicator, place the vaginal insert into the vagina. Throw applicator away.
    • 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 pouch is 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)
  • this is a 1-dose treatment. Most women do not get complete relief of their symptoms in just 1 day. Most women get some improvement in 1 day and complete relief by 7 days.

Inactive ingredients

INACTIVE INGREDIENT SECTION

vaginal insert: gelatin, glycerin, lecithin, mineral oil, titanium dioxide, white petrolatum

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 1-855-590-5695

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Miconazole 1
Miconazole Nitrate Vaginal Insert (1200 mg) &

Miconazole Nitrate Vaginal Cream (2%)


VAGINAL ANTIFUNGAL | COMBINATION PACK| 1-DAY TREATMENT

Cream for External Relief

  • Maximum Strength Insert

Net Wt. 0.32oz (9g) tube

1 Vaginal Insert Net Wt. 2.6g

Miconazole 1 Miconazole Nitrate Vaginal Insert (1200 mg) & Miconazole Nitrate Vaginal Cream (2%) VAGINAL ANTIFUNGAL | COMBINATION PACK| 1-DAY TREATMENT Cream for External Relief...Miconazole 1 Miconazole Nitrate Vaginal Insert (1200 mg) & Miconazole Nitrate Vaginal Cream (2%) VAGINAL ANTIFUNGAL | COMBINATION PACK| 1-DAY TREATMENT Cream for External Relief...

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-5201-012023-01-30C16284748780-1f386c649-da85-0266-e053-dadaa90a7c1aMiconazole 1 Combination Pack
0363-5201-012023-01-30C16284748780-1f386c649-da85-0266-e053-dadaa90a7c1aMiconazole 1 Combination Pack

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-52010363-5201-01
0363-52040363-5204-01
0363-52050363-5205-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
Miconazole NitrateVW4H1CYW1KACTIB
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
MINERAL OILT5L8T28FGPIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
PETROLATUM4T6H12BN9UIACT
Miconazole NitrateVW4H1CYW1KACTIB
Benzoic Acid8SKN0B0MIMIACT
Cetyl Alcohol936JST6JCNIACT
Isopropyl Myristate0RE8K4LNJSIACT
Polysorbate 60CAL22UVI4MIACT
Potassium HydroxideWZH3C48M4TIACT
Propylene Glycol6DC9Q167V3IACT
Water059QF0KO0RIACT
Stearyl Alcohol2KR89I4H1YIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42021-08-30full-release2026-05-31 23:45:09

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
N021308-001MONISTAT 1 COMBINATION PACKMICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-29

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.

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 22:38:342026-08N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-2984e616aacf4f…
2026-08-18 06:07:402026-07N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS2001-06-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS2001-06-2987673890dc5c…
2021-03-12 10:30 UTC2021-03N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS2001-06-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS2001-06-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS2001-06-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS2001-06-293f01610625f2…
2019-09-15 20:21 UTC2019-09N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS2001-06-29b00525d2431f…
2019-07-19 19:46 UTC2019-07N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS2001-06-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-293f0d92c62455…
2023-05-13 08:27 UTC2023-05N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-29053a50430f4f…
2023-01-26 05:58 UTC2023-01N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-29f41ea6bd6efb…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021308-00161536352020-11-28Delist requested74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N021308-00161536352020-11-28Delist requested8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021308-00161536352020-11-28Delist requestedc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021308-00161536352020-11-28Delist requested3f01610625f2…
2019-09-15 20:21 UTC2019-09N021308-00161536352020-11-28Delist requestedb00525d2431f…
2019-07-19 19:46 UTC2019-07N021308-00161536352020-11-28Delist requestedea99ee380514…

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 1 WalgreensMICONAZOLE NITRATEWALGREEN COMPANY1fe7b02a-f60b-4572-b4e8-35bda290b1762026-01-23WarningsExact identifier
ndc (package): 0363-5201-01
ndc (package): 0363-5204-01
ndc (package): 0363-5205-01
ndc (product): 0363-5201
ndc11 (package): 00363520501
ndc11 (package): 00363520401
ndc11 (package): 00363520101
spl id: 2a57ccf7-f616-40e9-a19d-2a0c547c1084
spl set id: 1fe7b02a-f60b-4572-b4e8-35bda290b176

Reported adverse events (FAERS/openFDA)#

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