FDA.reportPublic FDA data

Monistat 3 Combination Pack

Manufacturer
Insight Pharmaceuticals LLC
Effective date
2025-10-27
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:40:41

Label at a glance#

ProductMonistat 3 Combination Pack
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: applicators : insert 1 applicatorful into the vagina at bedtime for 3 nights in a row. Throw away applicator after use. external cream: squeeze a small amount of cream onto your fingertip. Apply the cream onto the itchy, irritated skin outside the vagina. Us...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Miconazole nitrate 4%
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

  • 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.

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:
  • applicators: insert 1 applicatorful into the vagina at bedtime for 3 nights in a row. Throw away applicator 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 applicator wrapper 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)
  • Keep this carton for future reference. It contains important information.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

If you have any questions or comments, please call 1-877-666-4782

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

- Kit Carton

MONISTAT® 3

COMBINATION PACK

Miconazole Nitrate Vaginal Cream (4%) and Miconazole Nitrate Cream (2%) - Vaginal Antifungal

3 PREFILLED APPLICATORS             Net Wt. 0.18 oz. (5g) +0.32 oz. (9g) tube 

MONISTAT® 3 COMBINATION PACK Miconazole Nitrate Vaginal Cream (4%) and Miconazole Nitrate Cream (2%) - Vaginal Antifungal 3 PREFILLED APPLICATORS Net Wt. 0.18 oz. (5g) +0.32 oz....MONISTAT® 3 COMBINATION PACK Miconazole Nitrate Vaginal Cream (4%) and Miconazole Nitrate Cream (2%) - Vaginal Antifungal 3 PREFILLED APPLICATORS Net Wt. 0.18 oz. (5g) +0.32 oz....

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1536604{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream [Monistat]) / 3 (5000 MG) (miconazole nitrate 40 MG/ML Vaginal Cream [Monistat]) } Pack [Monistat 3 Vaginal Cream Combination Pack with Vaginal Creams]BPCK9
992816{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) / 3 (5000 MG) (miconazole nitrate 40 MG/ML Vaginal Cream) } PackGPCK9
992816miconazole 3 Day - (4 % applicator 5 GM / 2 % cream 9 GM) PackPSN9
998540miconazole nitrate 2 % Vaginal CreamPSN9
998544miconazole nitrate 4 % Vaginal CreamPSN9
998541Monistat 2 % Vaginal CreamPSN9
998546MONISTAT 3 4 % Vaginal CreamPSN9
1536604Monistat 3 Vaginal Cream and Topical Cream Combination Pack with Prefilled ApplicatorsPSN9
998541miconazole nitrate 20 MG/ML Vaginal Cream [Monistat]SBD9
998546miconazole nitrate 40 MG/ML Vaginal Cream [Monistat]SBD9
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD9
998544miconazole nitrate 40 MG/ML Vaginal CreamSCD9
992816{3 (5 GM miconazole nitrate 200 MG (4 % ) Prefilled Applicator) / 1 (9 GM miconazole nitrate 2 % Vaginal Cream) } PackSY9
992816{3 (5000 MG miconazole nitrate 4 % Prefilled Applicator) / 1 (0.32 OZ miconazole nitrate 2 % Vaginal Cream) } PackSY9
992816Miconazole 3 Day Prefilled Applicator Combination PackSY9
998540miconazole nitrate 2 % Vaginal CreamSY9
998544miconazole nitrate 4 % Vaginal CreamSY9
998541Monistat 20 MG/ML Vaginal CreamSY9
1536604Monistat 3 Vaginal Cream and Topical Cream Combination Pack with Prefilled ApplicatorsSY9
998546Monistat 4 % Vaginal CreamSY9
998546Monistat 40 MG/ML Vaginal CreamSY9

DailyMed Pharmacologic Classes#

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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63736-010-01Monistat 3 Combination Pack1 in 1 PACKAGE, COMBINATIONKIT19

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63736-01063736-010-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICONAZOLE NITRATEVW4H1CYW1KACTIB
BENZOIC ACID8SKN0B0MIMIACT
CETYL ALCOHOL936JST6JCNIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
POLYSORBATE 60CAL22UVI4MIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
STEARYL ALCOHOL2KR89I4H1YIACT
Miconazole NitrateVW4H1CYW1KACTIB
Benzoic Acid8SKN0B0MIMIACT
Cetyl Alcohol936JST6JCNIACT
Isopropyl Myristate0RE8K4LNJSIACT
Polysorbate 60CAL22UVI4MIACT
Potassium HydroxideWZH3C48M4TIACT
Propylene glycol6DC9Q167V3IACT
Water059QF0KO0RIACT
Stearyl Alcohol2KR89I4H1YIACT

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72024-11-25full-release2026-06-01 00:38:33

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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)MICONAZOLE NITRATE2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-02
N021261-003MONISTAT 3 COMBINATION PACKMICONAZOLE NITRATE2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-17

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 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-02c2088c7a36db…
2026-10-15 13:18:302026-09N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-17c2088c7a36db…
2026-09-14 22:38:342026-08N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-0284e616aacf4f…
2026-09-14 22:38:342026-08N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-1784e616aacf4f…
2026-08-18 06:07:402026-07N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-02caaa826d4ba7…
2026-08-18 06:07:402026-07N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-02d06236e962d9…
2024-10-29 15:01 UTC2024-10N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-028072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-174b0b4de00fa7…

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
Monistat 3 Combination PackMICONAZOLE NITRATEInsight Pharmaceuticals LLCe1b8ad40-5adb-482a-b532-3f8e30d901282025-10-27WarningsExact identifier
ndc (package): 63736-010-01
ndc (product): 63736-010
ndc11 (package): 63736001001
spl id: 03108766-1001-4aac-9dd8-799a63662a25
spl set id: e1b8ad40-5adb-482a-b532-3f8e30d90128

Reported adverse events (FAERS/openFDA)#

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